[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anxiety":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,623,0,25,[9,52,75,111,135,170,201,231,257,285,310,338,364,392,413,440,468,501,531,553,590,608,640,673,694],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100652765","the-effect-of-using-virtual-reality-glasses-and-gaming-cards-on-fear-anxiety-and-physiological-parameters-in-children-administered-inhaler-medication-100652765",false,"NCT07780331","The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication","Inclusion Criteria:\n\n* Child being between the ages of 4 and 6 years.\n* Parents and children being completely voluntary to participate in the study.\n* Child having no visual, auditory, or cognitive communication barriers.\n* Child's cognitive level and motor development being appropriate for their age.\n* Child having no life-threatening acute or chronic systemic disease.\n* Child having no mental or neurological disability or condition.\n* Child and parent being fully open to effective communication and clinical cooperation.\n* Child having no medical condition that prevents inhaler mask or nebulizer application.\n\nExclusion Criteria:\n\n* Child having any acute clinical condition that mechanically prevents inhaler treatment.\n* Child having a severe, life-threatening acute or chronic health problem at presentation.\n* Sudden development of severe clinical instability preventing completion of the trial.",true,"ALL","4 Years","6 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate the effects of using virtual reality headsets and play cards during the administration of inhaler medication in pediatric patients. The primary goal is to determine how these distraction methods influence children's fear, anxiety levels, and physiological parameters (such as heart rate and oxygen saturation). The study population consists of pediatric patients aged between 4 and 6 years. Data collection for the targeted sample size of 150 children commenced in September, and the recruitment process is currently ongoing.Children receiving inhaler treatments often experience fear and anxiety, which can negatively affect their treatment compliance and vital signs. In this study, participants are divided into different groups to compare the effectiveness of virtual reality headsets and traditional play cards as distraction tools.",[28,29,30,31],"Respiratory Tract Diseases","Pediatric Disorders","Anxiety","Fear",[33,34,35,36,31,37,38],"Virtual Reality","Distraction Techniques","Inhalation Therapy","Procedural Anxiety","Pediatric Nursing","Randomized Controlled Trial","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2025-09-28",{"date":47,"type":22},"2026-10",{"name":49,"class":50},"Bandırma Onyedi Eylül University","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":51},"100634672","phase-4-diphenhydramine-as-an-adjunct-to-moderate-sedation-for-procedural-first-trimester-abortions-100634672","NCT07542730","Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions","Inclusion Criteria:\n\n* Adults age 18 years and older\n* Desire procedural abortion with moderate sedation\n* Gestational age less than or equal to 13 weeks\n* Intrauterine pregnancy or pregnancy of unknown location\n* Body mass index less than or equal to 40\n\nExclusion Criteria:\n\n* Desire medical abortion or desire to continue pregnancy\n* Gestational age greater than 13 weeks\n* Body mass index greater than 40\n* Age younger than 18 years\n* Confirmed ectopic pregnancy\n* Medical condition that is a contraindication to moderate sedation as determined by the treating clinician","FEMALE","18 Years",{"count":61,"type":22},98,[63],"PHASE4","This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.",[66,67,30],"Pain","Abortion",{"date":42,"type":43},{"date":70,"type":43},"2026-06-29",{"date":72,"type":22},"2027-02",{"name":74,"class":50},"University of Rochester",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":16,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":51},"100652087","ai-based-personalized-exercise-prescription-through-mobile-health-on-physical-activity-and-health-outcomes-in-older-adults-a-feasibility-study-100652087","NCT07768670","AI-Based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study","Artificial Intelligence-based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study","Inclusion Criteria:\n\n* Be aged 65 years or older.\n* Own a smartphone (Android or iOS) compatible with study applications.\n* Have reliable access to the internet or Wi-Fi.\n* Demonstrate basic digital literacy sufficient to operate a smartphone (e.g., ability to open applications, navigate simple interfaces, and follow on-screen instructions), with or without initial guidance from the research staff.\n* Be able to safely engage in physical activity, as determined by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) or physician approval if indicated.\n* Report engaging in less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week.\n* Be able to communicate in English sufficiently to complete study procedures and assessments.\n\nExclusion Criteria:\n\n* Are younger than 65 years of age.\n* Do not own a compatible smartphone (Android or iOS) or do not have reliable internet\u002FWi-Fi access.\n* Are deemed unable to safely participate in physical activity based on the screening process (including PAR-Q+, STEADI, and research staff assessment), or do not obtain required physician clearance when indicated.\n* Currently meet or exceed 150 minutes of moderate-to-vigorous physical activity (MVPA) per week.\n* Are unable to communicate in English sufficiently to understand study procedures, provide informed consent, or complete study-related assessments.\n* Have any medical, physical, or cognitive condition that, in the judgment of the research team, would make participation unsafe or prevent completion of study procedures.","65 Years",{"count":84,"type":22},20,[25],"The purpose of this research is to investigate the feasibility, acceptability, appropriateness, and preliminary efficacy of a wearable and artificial intelligence-driven mobile application-based exercise prescription grounded in self-determination theory (SDT) and behavioral change techniques (BCTs) among older adults. As no data exists on the feasibility of AI-driven exercise programs grounded in SDT and multiple BCTs specifically for older adults, this will be a pioneering study to explore the feasibility of wearable and AI-driven exercise program protocols and the rates of acceptance and appropriateness of the exercise prescription intervention among older adults. In addition, this study will test the preliminary efficacy of the intervention on physical activity (PA), mental health, and quality of life. This study follows the National Institute of Health (NIH) stage model, and it represents stage 1b of the NIH stage model, which emphasizes the feasibility and actionable processes for delivering a new health intervention. Specifically, this study will: 1.Evaluate the research protocol feasibility of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs (of goal setting, self-monitoring, graded task, and demonstration) on older adults over 8 weeks 2. Evaluate the acceptability and appropriateness of a wearable, AI-driven, mobile application-based exercise prescription grounded in SDT and BCTs among older adults over 8 weeks. 3. Evaluate the preliminary impact of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs on older adult PA (steps per day and daily duration of light PA and Moderate-vigorous PA), sedentary time, sleep, mental health (depression and anxiety), and quality of life.",[88,89,90,30,91],"Feasibility Studies","Physical Activity","Mental Health (Depression)","Quality of Life",[93,94,95,96,97,98,99,100,101],"AI-based intervention","mobile health technology","wearable","fitness app","feasibility study","study acceptability and appropriateness","older adult","age 65 years","60 years","2026-08-18",{"date":104,"type":43},"2026-08-20",{"date":106,"type":22},"2026-10-01",{"date":108,"type":22},"2026-12-31",{"name":110,"class":50},"The University of Tennessee, Knoxville",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":51},"100643043","the-effect-of-rhythmc-skn-tappng-and-internal-vbraton-appled-proxmal-to-the-procedure-ste-on-pan-and-fear-percepton-durng-pedatrc-perpheral-venpuncture-100643043","NCT07650591","THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE","THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE: A RANDOMİZED CONTROLLED TRİAL","Inclusion Criteria:\n\n* Being between 6 and 12 years of age\n\nRequiring a peripheral venipuncture procedure\n\nHaving written informed consent from the parents\n\nHaving verbal assent from the child\n\nBeing able to speak and understand Turkish\n\nHaving a cognitive development level appropriate for age\n\nAbsence of any chronic pain condition\n\nExclusion Criteria:\n\n* Refusing to participate in the study or wishing to withdraw at any stage\n\nDevelopment of complications during the procedure\n\nHaving used analgesics within the last 24 hours\n\nHaving previously participated in the same study\n\nImpaired skin integrity at the procedure site\n\nHaving a neurological or psychiatric diagnosis","12 Years",{"count":120,"type":22},126,[25],"What is this study about, in short?\n\nThis study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested:\n\n* A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go (\"rhythmic skin tapping\").\n* The child making an \"mmmm\" humming sound while the blood is being drawn (\"internal vibration\" or \"humming\").\n\nThese methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method.\n\nWhy is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children.\n\nSome methods used to reduce pain have practical limits:\n\n* Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost.\n* Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene.\n\nFor these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that.\n\nHow do the methods work? (Simple science) Both methods rest on an idea called the \"Gate Control Theory\": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a \"gate\" that partly blocks the pain signal from reaching the brain.\n\n* Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help \"close the gate,\" so the pain is felt less.\n* Internal vibration (humming): The \"mmmm\" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control.\n\nWho can take part in the study?\n\nCan take part:\n\n* Children aged 6-12 years\n* Children who will have a blood draw\n* Children whose parent has given written permission and who themselves agree verbally\n* Children who can understand and speak Turkish\n* Children whose cognitive development is appropriate for their age\n* Children who do not have an ongoing (chronic) pain condition\n\nCannot take part, or will be withdrawn:\n\n* Children who do not want to take part, or wish to withdraw at any stage\n* Children who develop a complication (an unexpected medical problem) during the procedure\n* Children who have used a painkiller within the last 24 hours\n* Children who have already taken part in this study before\n* Children whose skin is broken at the site where the needle will go\n* Children who have a neurological or psychiatric diagnosis\n\nWhat will happen if my child takes part?\n\nThe blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step:\n\n* Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called \"randomization\" and it keeps the comparison fair.\n* The blood draw is done as usual. The only difference is the method used, depending on your child's group.\n* Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4).\n* A short form collects details such as age, sex, and any previous blood-draw experience.\n* No extra needle, medicine, or laboratory test is done beyond the routine blood draw.\n\nThe three groups are:\n\nGroup What is done in this group?\n\n1. Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site.\n2. Internal vibration (humming) The child is asked to make an \"mmmm\" humming sound during the blood draw.\n3. Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods.\n\nWhere and when will the study take place?\n\n* Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye).\n* Data collection period: June 2026 - June 2027. The total study duration is about 12 months.\n* Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable.\n\nTaking part is completely voluntary\n\n* Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason.\n* Not taking part, or withdrawing, will not affect the health care your child receives in any way.\n* Your child may also say they do not want the method; the child's decision is",[124,125,126,31,30,127],"Procedural Pain","Acute Pain","Needle-Related Pain and Distress","Phlebotomy",{"date":40,"type":43},{"date":130,"type":43},"2026-07-01",{"date":132,"type":22},"2027-06",{"name":134,"class":50},"Akdeniz University",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":51},"100652383","effect-of-alpha-binaural-beat-music-on-pain-after-orthodontic-separator-placement-100652383","NCT07771920","Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement","The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial","ABB-PainRCT","Inclusion Criteria:\n\n* Patients aged 15-30 years.\n* Permanent dentition.\n* Mild crowding (≤3 mm arch length discrepancy).\n* Good periodontal health.\n* Requirement for fixed orthodontic treatment.\n* Requirement for bilateral maxillary first molar banding.\n* Requirement for placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar.\n* Ability to understand study instructions and complete study assessments.\n* Willingness to use stereo headphones.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Previous fixed orthodontic treatment.\n* Congenital or acquired hearing impairment.\n* Use of hearing aids or assistive listening devices.\n* History of tinnitus, hyperacusis, or sound sensitivity.\n* Active ear infection.\n* Recent upper respiratory tract infection associated with ear symptoms.\n* Neurological disorders.\n* Psychiatric disorders requiring treatment, including anxiety and depressive disorders.\n* Current use of analgesics, anti-inflammatory medications, antidepressants, anxiolytics, antipsychotics, or sedatives.\n* Chronic pain disorders.\n* Active periodontal disease or significant gingival inflammation.\n* Active dental pain, pulpal pathology, or oral infection.\n* Inability or unwillingness to use stereo headphones.\n* Inability to understand study instructions or complete study assessments.","15 Years","30 Years",{"count":146,"type":22},72,[25],"Orthodontic pain is one of the most frequently reported adverse experiences during fixed appliance therapy and is particularly pronounced during the initial stages of treatment. Placement of orthodontic separators, a routine procedure performed to create interproximal space for orthodontic band placement, often causes discomfort that may negatively influence patient motivation, treatment acceptance, and overall orthodontic experience. Psychological factors, particularly anxiety, may also influence pain perception and contribute to individual differences in pain responses during orthodontic treatment. Therefore, interventions that address both pain and anxiety may improve patient comfort and adaptation to treatment.\n\nBinaural beats are auditory stimuli generated when two slightly different frequencies are presented separately to each ear, resulting in the perception of a third frequency equal to the difference between the two tones. Alpha-frequency binaural beats (8-13 Hz) have been associated with relaxation and reduced psychological arousal and have demonstrated promising analgesic and anxiolytic effects in various medical and dental settings. However, limited evidence exists regarding their role in the management of orthodontic pain following separator placement.\n\nThis prospective parallel-arm randomized controlled trial aims to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain and anxiety following separator placement. Seventy-two orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be recruited from the orthodontic clinics of Aga Khan University Hospital, Karachi, Pakistan. To minimize potential confounding factors and standardize the painful stimulus, all participants will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar. Participants will be randomly allocated in a 1:1 ratio to either an intervention group receiving alpha-frequency binaural beat stimulation or a control group undergoing a standardized five-minute resting period without auditory stimulation.\n\nThe binaural beat intervention consists of an 11-Hz alpha-frequency stimulus generated through the presentation of a 285-Hz carrier tone to one ear and a 296-Hz carrier tone to the other ear. Participants assigned to the intervention group will listen to a standardized pre-recorded audio file through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), anxiety levels will be measured using the Visual Analogue Scale for Anxiety (VAS-A), and analgesic consumption will be recorded during the observation period. Assessments will be conducted before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure.\n\nThe primary objective of this study is to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the 48-hour observation period. The findings of this study will provide evidence regarding the effectiveness of alpha-frequency binaural beats as a simple, inexpensive, safe, and non-pharmacological adjunct for reducing orthodontic pain and anxiety and improving patient comfort during the early stages of orthodontic treatment.",[150,30],"Orthodontic Pain (D013850)",[152,153,154,155,156,30,157,158,159,160],"Orthodontics","Orthodontic Appliances","Orthodontic Pain","Pain Measurement","Acoustic Stimulation","Orthodontic Separators","Alpha Binaural Beats","Music Therapy","Nonpharmacological Pain Management","NOT_YET_RECRUITING","2026-08-17",{"date":40,"type":43},{"date":165,"type":22},"2026-08-03",{"date":167,"type":22},"2026-09-18",{"name":169,"class":50},"Aga Khan University",{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":190,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":51},"100652361","anxiety-skills-study-100652361","NCT07774481","Anxiety Skills Study","Personalizing and Optimizing CBT Skills for Anxiety","Inclusion Criteria:\n\n* Presence of clinically elevated anxiety\n* Living in Ohio\n\nExclusion Criteria:\n\n* No access to a smartphone\n* Presence of conditions that would necessitate alternative care",{"count":178,"type":22},600,[25],"The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.",[30,182,183,184,185,186,187,188,189],"Anxiety Acute","Anxiety Chronic","Anxiety and Mood Disorders","Social Anxiety Disorder","Panic Disorder (With or Without Agoraphobia)","Generalized Anxiety Disorder","Obsessive-Compulsive Disorder","Specific Phobia",[191,192,193],"anxiety","CBT","treatment",{"date":40,"type":43},{"date":196,"type":43},"2025-10-20",{"date":198,"type":22},"2030-08-31",{"name":200,"class":50},"Ohio State University",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":16,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":219,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":51},"100652211","the-effect-of-multisensory-stimulation-administered-before-clinical-encounters-at-the-pediatric-surgery-outpatient-clinic-on-childrens-anxiety-and-fear-levels-and-parental-anxiety-100652211","NCT07769788","The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety","The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety: A Randomized Controlled Study","Inclusion Criteria:\n\n* For the children to be sampled, the inclusion criteria plan to involve children who:\n* Are aged between 5 and 10 years,\n* Are undergoing their first outpatient pediatric surgery evaluation,\n* Have no prior history of surgery, and Agree (along with their parents) to voluntarily participate in the study.\n\nExclusion Criteria:\n\n* For the children to be sampled, the exclusion criteria plan to omit children who:\n* Are in unstable general condition or require emergency medical intervention,\n* Have intellectual disabilities, or Have visual or hearing impairments.","5 Years","10 Years",{"count":211,"type":22},80,[25],"Encounters with healthcare services during childhood, particularly surgical evaluation processes, are a significant source of stress for both children and their parents. The initial evaluation, physical examination, and the prospect of a possible procedure conducted in pediatric surgery outpatient clinics can lead to increased levels of anxiety and fear in children. This situation not only affects the child's current psychological state but also reduces their cooperation during the examination, makes collaboration with healthcare professionals more difficult, and can negatively impact the overall healthcare experience. Increased levels of anxiety and fear in children are not limited to emotional reactions alone; they also affect physiological and behavioral responses, thereby shaping the entire healthcare process. Similarly, parents may also experience significant situational anxiety due to uncertainty about their child's health status, the possibility of surgical intervention, and the responsibility for care. Parental anxiety is a significant factor that can influence children's levels of anxiety and fear and can indirectly shape the child's healthcare experience through parent-child interaction.",[30,31,215,216,217,218],"Multisensory Stimulation","Pediatric Surgery","Parental Anxiety","Randomized Controlled Study",[191,220,221,222,223],"fear","parental anxiety","multisensory stimulation","pediatric surgery",{"date":40,"type":43},{"date":226,"type":22},"2026-07-29",{"date":228,"type":22},"2026-09-01",{"name":230,"class":50},"Bilecik Seyh Edebali Universitesi",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100535845","comparing-radiotherapy-immobilization-systems-for-anxious-hnc-patients-100535845","NCT06257121","Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients","A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety","CRISP","Inclusion Criteria:\n\n* Eighteen years of age or older\n* Able to fluently speak, read and write French or English\n* Histologically confirmed head and neck cancer\n* Patients treated with radiotherapy as primary treatment\n* Identified as having moderate mask anxiety \u002F claustrophobia (i.e. a score of 10 or more on the Generalized Anxiety Disorder 7 item (GAD-7) questionnaire and \u002F or a score of 28 or more on the Claustrophobia questionnaire (CLQ) suffocation subscale and \u002F a score of 24 or more on the CLQ restriction subscale\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-2\n* Able to understand and sign consent form\n* Patients must be willing to comply with treatment plan and other study procedures\n\nExclusion Criteria:\n\n* Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study\n* Patients who cannot stay still during fraction because of a disorder or physical condition (e.g., Parkinson's disease)",{"count":240,"type":22},15,[25],"Background: Radiotherapy is a mainstay of treatment for ENT cancers, and its indication is frequent. Patients are positioned and immobilized using a thermoplastic mask, which is attached to the treatment table for the duration of each daily treatment. The mask's purpose is to prevent patient movement and ensure reproducible positioning. The advantages of using thermoplastic masks come at a cost for many patients. It is well established that mask fixation and mask anxiety are major concerns for patients, adversely affecting their quality of life and hindering treatment compliance. Surface-guided radiotherapy (SGRT) enables patients to be positioned and their movements monitored in real time during treatment. This technique has become more widely available in recent years, and is attractive because it does not involve ionizing radiation. However, although preliminary data have suggested a potential reduction in anxiety, this technique has not been evaluated for ENT RT in anxious\u002Fclaustrophobic patients who cannot tolerate immobilization masks.\n\nObjective: Investigators propose a pilot study to evaluate the feasibility and tolerability of using SGRT to manage position for patients with ENT cancer who report claustrophobia\u002Fanxiety.\n\nMethodology: 15 participants will be recruited by the treating radiation oncologist from among patients scheduled to undergo radiation therapy at CHUM for their ENT cancer and identifying as claustrophobic\u002Fanxious. Participants who consent will be scheduled to undergo their radiotherapy using SGRT. Patients will be systematically treated with Volumetric Modulated Arc Therapy (VMAT) using SGRT on the linear accelerator with the Optical Surface Management System (OSMS) for the duration of the radiotherapy.\n\nMeasures: Patients' anxiety will be assessed using the GAD-7 and the CLQ throughout the treatment process. The feasibility and accuracy of radiotherapy treatment will be assessed using planning and daily pre-treatment examinations. In addition, skin toxicity will be assessed weekly.\n\nAnalyses: 1) Descriptive analyses, i.e. frequencies for categorical variables and means and standard deviations for continuous variables. 2) Estimation of confidence intervals.\n\nAnticipated outcomes: Completion of this pilot project will enable investigators to plan and refine the methodological and organizational aspects for a large-scale study, i.e., a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients.",[244,245,30],"Head and Neck Cancer","Claustrophobia",[247,30,245,248,249],"Head and neck cancer","Surface-guided imagery","Radiation therapy",{"date":40,"type":43},{"date":252,"type":22},"2026-10-15",{"date":254,"type":22},"2029-02-01",{"name":256,"class":50},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":284},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":264,"type":22},300,[25],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[268,269,30],"Post Traumatic Stress Disorder (PTSD)","Depression",[271,268,272,273,274,269,30,275],"Psychological Distress","Mindfulness","Primary Care","Brief Intervention","Problem-solving training",{"date":40,"type":43},{"date":278,"type":43},"2024-08-19",{"date":280,"type":22},"2027-12-31",{"name":282,"class":283},"VA Office of Research and Development","FED",4,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":301,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":51},"100587993","healing-hearts-of-hospitalized-patients-100587993","NCT06935604","Healing Hearts of Hospitalized Patients","Healing Hearts of Hospitalized Patients With Virtual Reality: A Pragmatic, Crossover Trial","Inclusion Criteria:\n\n* Adults aged 18 years and above\n* Able to provide informed consent\n* Able to follow verbal instructions\n* Adequate motor skills for upper extremities to operate VR equipment\n* Clinically stable\n* English speaking\n* Willing to participate in mindfulness activities\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Clinically unstable\n* Facial trauma prohibiting headset use\n* Physical limitations in facial, neck, upper extremities that hinder use of VR equipment\n* History of seizures or other neurological conditions\n* Severe motion sickness\n* Active nausea\n* Severe visual impairment\n* Severe cognitive impairment","99 Years",{"count":294,"type":22},42,[25],"The study aims to evaluate the impact of a bedside-delivered virtual reality (VR) mindfulness experience on well-being and psychosocial outcomes among hospitalized adult patients compared to standard of care (SOC; no added mindfulness intervention).",[298,30,299,300],"Well-Being, Psychological","Affect","Relaxation",[33],"2026-08-16",{"date":102,"type":43},{"date":305,"type":43},"2026-05-07",{"date":307,"type":22},"2027-05-31",{"name":309,"class":50},"Stanford University",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100610876","high-intensity-low-frequency-periodic-rtms-over-the-right-dorsolateral-prefrontal-cortex-on-cardiac-autonomic-regulation-in-women-with-recurrent-pregnancy-loss-and-anxiety-100610876","NCT07233278","High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety","High-intensity, Low-frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex for Acute Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Generalized Anxiety Disorder: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-rTMS-2)","Inclusion Criteria:\n\n* (i) Female, aged 18-45 years, and right-handed;\n* (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;\n* (iii) Not currently pregnant or in a state of missed miscarriage;\n* (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17.\n\nExclusion Criteria:\n\n* (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;\n* (ii) Unstable blood pressure (systolic \\>180 mmHg or \\\u003C90 mmHg);\n* (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;\n* (iv) Significant suicide risk;\n* (v) Other current major psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium. To preserve diagnostic homogeneity of the study sample, participants whose current primary diagnosis is another anxiety-related disorder will also be excluded, including panic disorder, social anxiety disorder, separation anxiety disorder, specific phobia, obsessive-compulsive and related disorders, and trauma- and stressor-related disorders; Current use of psychotropic medication at screening, or continuous use within the 4 weeks before screening of antidepressants, anxiolytics, antipsychotics, mood stabilizers, or sedative-hypnotics, in order to minimize hemodynamic confounding.","45 Years",{"count":319,"type":22},48,[25],"The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are:\n\nDoes 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation?\n\nDoes 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation?\n\nResearchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity.\n\nParticipants will:\n\nUndergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC;\n\nHave continuous electrocardiography (ECG) recordings collected during the entire stimulation session;\n\nComplete clinical and psychiatric assessments before participation.",[323,30],"Recurrent Pregnancy Loss(RPL)",[325,30,326,327,328],"Recurrent pregnancy loss","Dorsolateral Prefrontal Cortex","Cardiac Autonomic Regulation","repetitive transcranial magnetic stimulation","2026-08-15",{"date":102,"type":43},{"date":332,"type":43},"2025-11-19",{"date":334,"type":22},"2026-12-30",{"name":336,"class":50},"Shenyang Medical College",3,{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":51},"100638123","active-vs-passive-vr-during-office-based-ent-procedures-100638123","NCT07599826","Active vs. Passive VR During Office-based ENT Procedures","Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures","Inclusion Criteria Active and Passive VR:\n\n* Individuals 18 years old and older are included\n* Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (RhinAer\u002FVivAer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection\n* Able to consent\n* English speaking\n\nExclusion Criteria Active VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller\n* Any records flagged \"break the glass\" or \"research opt out.\"\n\nExclusion Criteria Passive VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo\n* Any records flagged \"break the glass\" or \"research opt out.\"",{"count":346,"type":22},132,[25],"The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars-Sinai.",[66,30,350,351,352,353,354,355],"Chronic Rhinosinusitis (CRS)","Nasal Obstruction","Nasal Polyp","Eustachian Tube Dysfunction","Dysphonia","Subglottic Stenosis (SGS)","2026-08-13",{"date":162,"type":43},{"date":359,"type":22},"2026-09",{"date":361,"type":22},"2027-12",{"name":363,"class":50},"Cedars-Sinai Medical Center",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":380,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":51},"100650942","dexmedetomidine-esketamine-combination-on-depression-and-anxiety-after-laparoscopic-ureteral-reconstruction-100650942","NCT07753772","Dexmedetomidine-Esketamine Combination on Depression and Anxiety After Laparoscopic Ureteral Reconstruction","Perioperative Use of Dexmedetomidine-esketamine Combination on Depression and Anxiety in Patients Undergoing Laparoscopic Ureteral Reconstruction: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged ≥ 18 years;\n2. Diagnosed with ureteral stricture and scheduled for elective laparoscopic ureteral reconstruction under general anesthesia;\n3. Requiring patient-controlled intravenous analgesia after surgery.\n\nExclusion Criteria:\n\n1. Preoperative inability to communicate due to coma, delirium, severe dementia, or language barrier;\n2. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;\n3. Presence of preexisting left ventricular ejection fraction (LVEF) \\\u003C 30%, sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C 50 beats\u002Fmin), or atrioventricular block above grade II without pacemaker implanted;\n4. Uncontrolled hyperthyroidism or history of pheochromocytoma;\n5. Severe hepatic insufficiency (Child-Pugh Class C), severe renal insufficiency (required preoperative dialysis), or American Society of Anesthesiologists (ASA) physical status classification ≥ IV;\n6. Allergy to dexmedetomidine and\u002For esketamine;\n7. Other conditions deemed unsuitable for study participation by the investigators.",{"count":372,"type":22},658,[63],"Anxiety and depressive symptoms are prevalent in patients undergoing surgical repair for ureteral stricture, driven by chronic pain, renal function concerns, and surgical uncertainty. Dexmedetomidine has anxiolytic and antidepressant effects but may increase bradycardia and hypotension; esketamine provides rapid antidepressant efficacy but may cause psychiatric side effects. Preliminary studies showed that combined use of low-dose dexmedetomidine and esketamine reduced the prevalence of postoperative depressive symptoms without increasing adverse events. This study is designed to test the hypothesis that perioperative use of low-dose dexmedetomidine-esketamine combination may relieve postoperative depressive symptoms and anxiety in patients undergoing laparoscopic ureteral reconstruction.",[376,377,378,379,30],"Ureteral Stricture","Dexmedetomidine","Esketamine","Depressive Symptoms",[381,377,378,382,30],"Laparoscopic ureteral reconstruction","Depressive symptoms","2026-08-12",{"date":385,"type":43},"2026-08-14",{"date":387,"type":22},"2026-08",{"date":389,"type":22},"2029-08",{"name":391,"class":50},"Peking University First Hospital",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":51},"100375079","the-role-of-virtual-reality-during-regional-anesthesia-100375079","NCT04163809","The Role of Virtual Reality During Regional Anesthesia","Inclusion Criteria:\n\n1. Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia\n2. Between ages 18-64\n3. Patient must be able to provide informed consent\n\nExclusion Criteria:\n\n1. Patients under the age of 18 \\& above age 64\n2. Visual impairment\n3. Pregnant women\n4. Diagnosis of epilepsy\u002Fseizures, dementia, and\u002For cognitive impairment","64 Years",{"count":211,"type":22},[25],"In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center.",[30,66],[404,191,405,406],"virtual reality","pain","regional anesthesia",{"date":385,"type":43},{"date":409,"type":22},"2027-01-01",{"date":411,"type":22},"2028-06",{"name":363,"class":50},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":424,"conditions":425,"keywords":426,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":439},"100624328","early-phase-1-sleep-dreaming-and-virtual-reality-for-mental-health-100624328","NCT07408206","Sleep, Dreaming, and Virtual Reality for Mental Health","Transformative Benefits of Contemplative Sleep Practices and a Novel Pathway to Deliver Benefits to the General Public","Inclusion Criteria:\n\n* Individuals interested in participating will be screened for eligibility through a Qualtrics survey, a Score between 5-21 points in GAD-7.\n\nHealthy, English-speaking adults (at least 18 years old) with high dream recall (at least 1\u002Fweek).\n\nExclusion Criteria:\n\n* We will exclude people who self-report any of the following:\n\n  1. history of an established meditative practice\n  2. psychological or psychiatric disorders (other than mild anxiety)\n  3. sleep disorders, nightshift work in the past month, extreme chronotype or irregular sleeping pattern\n  4. use of recreational drugs in the past month\n  5. history of asthma, seizures or heart problems\n  6. unwillingness to wear headband during sleep",{"count":421,"type":22},70,[423],"EARLY_PHASE1","People spend approximately one-third of their lives asleep, yet sleep is often underused as an opportunity to support psychological well-being. Contemplative traditions, including Tibetan Dream Yoga, have developed practices that use waking imagination and lucid dreaming to explore perception, awareness, and habitual patterns of thinking. Recent advances in sleep monitoring, dream communication, and lucid dream induction now make it possible to study these practices using scientific methods.\n\nThis study is a randomized controlled trial designed to examine the feasibility and effects of a Dream-Yoga-inspired intervention compared with an active control condition. The intervention combines waking and dreaming practices that are adapted for individuals without prior experience and delivered using virtual reality-based training and home sleep technology. The program is designed to be scalable and culturally neutral, without requiring prior knowledge of contemplative or religious traditions.\n\nThe primary goals of the study are to characterize sleep and waking neurophysiology associated with Dream-Yoga-inspired practices and to evaluate whether participation is associated with changes in sleep-related brain activity and cognitive processes. Outcomes include measures of lucid dreaming, sleep physiology, and waking cognitive and perceptual processes. Anxiety will be assessed as an exploratory outcome to examine whether participation may be associated with changes in emotional experience. This study is not designed to provide treatment for anxiety or other clinical conditions.\n\nResults from this study will help inform the development of scalable sleep-based mental training approaches and guide future research on the use of dreaming and sleep practices to support psychological health and well-being.",[30],[427,428,429,430,431],"lucid dreaming","dream yoga","contemplative practices","meditation","mind-body interventions","2026-08-11",{"date":356,"type":43},{"date":435,"type":43},"2026-01-15",{"date":280,"type":22},{"name":438,"class":50},"Northwestern University",2,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":51},"100585192","phase-2-psilocybin-assisted-therapy-for-intergenerational-trauma-100585192","NCT06899165","Psilocybin-Assisted Therapy for Intergenerational Trauma","Processing Intergenerational Trauma With Psilocybin-Assisted Therapy","Inclusion Criteria:\n\n* Age at least 18 years old at time of signing the informed consent.\n* Biological child of at least one parent who directly survived\u002Fescaped a genocide.\n* Evidence of clinically significant intergenerational trauma-related symptoms, as determined by the modified Parental PTSD Questionnaire (mPPQ).\n* Meet diagnostic criteria for a depressive, anxiety, trauma-, or stressor-related disorder on the Structured Clinical Interview for DSM-5 (SCID-5).\n* BMI of ≥ 17.\n* Capable of providing written informed consent and complying with study procedures.\n* If of reproductive potential, willing to use a highly effective method of contraception throughout study participation. Participants who can father a child and have partners of reproductive potential must also agree to use effective contraception throughout study participation.\n* Willing and medically appropriate to discontinue serotonergic medications before study treatment and remain off such medications throughout study participation, as determined by the study physician in consultation with the participant's treating healthcare provider.\n* Fluent in speaking and reading English.\n* Able to swallow pills.\n* Agree to have all study visits (both in-person and remote) recorded with audio and video.\n* Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable.\n* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n* Agree to release relevant medical and psychiatric records for eligibility determination and safety monitoring.\n* Agree to comply with protocol-specified lifestyle restrictions and study requirements.\n\nSafety note (not incl.\u002Fexcl. criteria): Note to Potential Participants: Individuals interested in this study should not stop, taper, or otherwise change prescribed medications before speaking with the study team. Any medication changes required for study participation will be evaluated by qualified study clinicians and, when appropriate, coordinated with the participant's treating healthcare provider.\n\nExclusion Criteria:\n\n* Individual was directly exposed to the genocide.\n* Current or recent illicit drug or prescription drug substance use disorder (excluding cannabis and tobacco use disorders), as determined by DSM-5 criteria and clinical assessment.\n* Current or recent alcohol or cannabis use disorder that, in the opinion of the investigator, may interfere with safe participation or study outcomes.\n* Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months.\n* Recent use of psychedelic substances.\n* Recent non-medical or illicit use of ketamine.\n* Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder.\n* Current serious suicide risk, recent suicidal behavior, or clinician concern that the participant poses a risk to self or others.\n* Acute, severe, or unstable medical illness, including clinical or laboratory evidence of severe renal and\u002For hepatic impairment.\n* Any physical or intellectual disability adversely affecting ability to complete assessments.\n* Current pregnancy or currently chest\u002Fbreastfeeding.\n* Any clinically meaningful abnormal laboratory test result, as determined by the investigator.\n* Current treatment with medications contraindicated with study treatment that cannot be safely tapered, discontinued, or substituted in accordance with the protocol.\n* History of clinically significant QT prolongation or other clinically significant cardiac conduction abnormality.\n* Use of medications known to prolong the QT interval that cannot be safely discontinued.\n* Any congenital prolongation of the QT interval or a family history of long QT syndrome.\n* A family history in a first-degree relative of psychosis\u002Fschizophrenia or related disorders as assessed by clinical interview with Study MD.\n* A first-degree family history of bipolar disorder as assessed by clinical interview with Study MD.\n* Current anorexia nervosa or bulimia nervosa as determined by DSM-V criteria using the SCID-V.\n* A clinically meaningful history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication.\n* Preexisting clinically meaningful cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension that may be worsened\u002Fexacerbated by elevated blood pressure or heart rate.\n* Neurological conditions including stroke, transient ischemic attack (TIA), epilepsy, neurodegenerative disease, brain tumor, or other neurological disorders that would impact participation in the trial.\n* Insulin-dependent diabetes.\n* Vital sign abnormalities at screening that exceed protocol-defined safety thresholds.\n* Hypersensitivity to psilocybin.\n* Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and\u002For safe exposure to psilocybin.\n* Positive toxicology findings not adequately explained by prescribed medications or approved treatment regimens.\n* Clinically meaningful abnormalities on screening electrocardiogram (ECG).\n* Fall risk if not mitigated by assistance from study staff.\n* Can't identify a support person who will be able to accompany them home and stay the night with them post experimental session.",{"count":448,"type":22},100,[450],"PHASE2","This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.\n\nThe study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.",[453,269,30],"Psychological Stress",[455,456,457,458,459,460],"psilocybin","psilocybin-assisted therapy","intergenerational trauma","psychedelic","stress","genocide",{"date":356,"type":43},{"date":463,"type":22},"2026-08-28",{"date":465,"type":22},"2030-01-02",{"name":467,"class":50},"Rachel Yehuda",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":476,"maxAge":118,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":284},"100651994","grow-with-grit-a-school-nurse-led-sbirt-pilot-for-early-anxiety-detection-100651994","NCT07766785","Grow With Grit: A School Nurse-Led SBIRT Pilot for Early Anxiety Detection","Grow With Grit: A Nurse-Led SBIRT Model for Early Anxiety Detection and School-Based Mental Health Intervention in Rural Youth","GwG","Inclusion Criteria:\n\n1. GFPS students aged 8-12 years and enrolled at one of the following schools:\n\n   Mountain View Elementary West Elementary Longfellow Elementary Sunnyside Elementary School\n2. Participants will be identified through a weekly review of school nurse electronic health records (Frontline EHR) and attendance logs, and will include students who have either:\n\n   1. Three or more nurse visits for somatic complaints within the past 6 weeks. For this study, somatic complaints are defined as the following physical symptoms that are not otherwise linked to exclusionary illness or chronic medical processes: stomach aches, headaches, fatigue, \\& generalized muscle aches.\n   2. Absenteeism greater than or equal to 10% of total school days due to the previously defined somatic complaints, within the past 6 weeks.\n   3. English-speaking without an interpreter (both student and guardian).\n\nExclusion Criteria\n\n1. Currently receiving ongoing behavioral health services, including psychotherapy, psychiatric medication management, or active behavioral health case management.\n\n   1. Brief, one-time crisis counseling is not considered ongoing services.\n   2. Questions about eligibility should be directed to the Principal Investigator.\n2. Presence of a chronic medical diagnosis that fully accounts for the student's repeated somatic visits (e.g., asthma with frequent exacerbations, epilepsy, diabetes, sickle cell disease, or active cancer treatment).\n\n   a. Students with partially explained symptoms who are also suspected to have co-occurring anxiety may be reviewed on a case-by-case basis by the PI\u002Fdesignee.\n3. Documented cognitive or communication impairments that preclude meaningful completion of the SCARED screening tool or informed assent.\n\n   1. Examples include moderate to severe intellectual disability or severe receptive\u002Fexpressive language disorder without feasible accommodations.\n   2. Students with an IEP or 504 plan that includes communication supports may be included if they can complete the tool with reasonable accommodations.\n4. Students who are wards of the state or in foster care.\n5. Non-English speaking students or guardians.\n6. Acute safety concerns at the time of screening (e.g., active suicidal ideation with plan\u002Fintent, recent suicide attempt, or other crisis requiring immediate intervention).\n\n   1. Such students will be triaged to crisis protocols and excluded from study participation at that time.","8 Years",{"count":478,"type":22},60,[25],"All enrolled students and their parents or guardians will complete baseline anxiety questionnaires. Students with a positive baseline screen will receive a brief school nurse-delivered coping skill, referral support when indicated, and follow-up assessments at approximately three and six months. Students with a negative screen will not enter the intervention and follow-up phase.",[30],[483,484,485,486,487,488,489,490,491,492,493],"pediatric anxiety","school nursing","school-based mental health","somatic symptoms","anxiety screening","early identification","Brief cognitive behavioral intervention","rural health","school absenteeism","SBIRT","elementary school students","2026-08-10",{"date":162,"type":43},{"date":497,"type":43},"2026-02-09",{"date":361,"type":22},{"name":500,"class":50},"McLaughlin Research Institute for Biomedical Sciences, Inc.",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":16,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":439},"100651870","virtual-nature-versus-guided-imagery-for-anxiety-and-well-being-in-hospitalized-older-adults-100651870","NCT07765355","Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults","Bottom-Up Virtual Nature Versus Top-Down Guided Imagery in Hospitalized Older Adults: A Randomized Parallel-Group Clinical Trial","Inclusion Criteria:\n\n* Aged 65 years or older\n* Receiving inpatient hospital care, with at least two weeks of hospitalisation at the time of enrolment\n* Montreal Cognitive Assessment (Hungarian version) score of 18 or above, with education correction\n* Physically able to safely wear a head-mounted virtual reality display\n* Adequate corrected or uncorrected vision and hearing\n* Able to communicate in Hungarian\n* Stable psychiatric and cardiovascular condition, as determined from medical history and in consultation with the treating physician\n* Able to provide independent written informed consent\n\nExclusion Criteria:\n\n* Epilepsy with recurrent seizures, or photosensitivity\n* Neurological condition associated with increased risk during virtual reality use, including Meniere's disease and significant carotid stenosis\n* Active psychosis, hallucinations, or severe depression with psychotic features\n* Open wound or skin lesion on the face, chronic neck pain, or spinal condition preventing safe use of the head-mounted display\n* Severe uncorrectable sensory impairment\n* Unstable psychotropic medication during the preceding eight weeks\n* Regular use of analgesic or psychotropic medication that may substantially affect perception of the experience\n* Active alcohol or substance use disorder within the past year\n* Refusal or inability to provide informed consent\n\nEnrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.",{"count":478,"type":22},[25],"Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside.\n\nThis study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination.\n\nBoth approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds.\n\nParticipants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end.\n\nThe main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.",[30,512,91,271,269],"Hospitalization",[404,514,515,516,517,518,519,520,521,522,523],"guided imagery","nature exposure","heart rate variability","hospitalized older adults","top-down processing","bottom-up processing","RMSSD","geriatrics","Katathym Imaginative Psychotherapy","symbol therapy",{"date":385,"type":43},{"date":526,"type":43},"2025-06-01",{"date":528,"type":22},"2027-01",{"name":530,"class":50},"Semmelweis University",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":51},"100650641","using-a-stress-ball-on-fear-anxiety-pain-and-satisfaction-during-allergy-testing-100650641","NCT07750236","Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing","The Effect of Watching Cartoons and Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing in Children","Inclusion Criteria:\n\n* Aged 4-10 years\n* Undergoing an allergy test for the first time\n* Voluntary participation by both the child and the parent\n\nExclusion Criteria:\n\n* The child must not have taken any medication prior to the skin test\n* The child must have a visual, hearing, or intellectual disability\n* The child must have a physical condition that would prevent them from using the stress ball",{"count":539,"type":22},90,[25],"This randomized controlled trial aims to evaluate and compare the effects of watching cartoons and using a stress ball on levels of fear, anxiety, pain, and satisfaction among 90 children aged 4-10 undergoing skin prick testing at the Pediatric Allergy Outpatient Clinic of Çukurova University Balcalı Hospital. Participants will be randomly allocated via a computer algorithm into three equal groups ($n = 30$ each): a cartoon-watching intervention group, a stress ball intervention group, and a control group receiving routine pediatric care. Data will be gathered using a Demographic Information Form, the Children's Fear Scale, the Children's Anxiety Scale-State, the Wong-Baker FACES Pain Rating Scale, and a Child Satisfaction Form at three time points-2 minutes prior to the test, immediately after the procedure, and at the 15th-minute post-test evaluation-through child, parent, and observer nurse assessments.",[543,30,31,66],"Child Allergy",[545,191,220,405,546],"child","satisfaction",{"date":432,"type":43},{"date":494,"type":43},{"date":550,"type":22},"2027-05-10",{"name":552,"class":50},"Tarsus University",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":144,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":51},"100594275","non-invasive-cranial-electrical-stimulation-for-mealtime-anxiety-in-adults-with-eating-disorders-100594275","NCT07017322","Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders","Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders","Inclusion Criteria:\n\n1. Age 18-30 years old at the time of enrollment\n2. Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location\n3. Have a primary diagnosis of any DSM-5 eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant\u002Frestrictive food intake disorder, other specified feeding or eating disorder)\n4. Ability to communicate effectively using written and spoken English\n5. Participant is eligible for mealtime anxiety support based on:\n\n   * ≤ 75% meal plan compliance\n   * Visible anxiety\u002Fdistress during program meals\n   * Engagement in compensatory behaviors or self-harm before, during, or after meals, or medical staff judge patient to be at risk of same\n\nExclusion Criteria:\n\n1. Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices\u002Fdefibrillators, prostheses)\n2. Currently taking medication that reduces seizure threshold (e.g., clomipramine)\n3. Cranial pathologies (e.g., holes, plates)\n4. History of seizure or black-out concussion\n5. Pregnancy\n6. Risk of suicide\u002Fself-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff\n7. Participant calibrates to a stimulation level below 200 microampere (μA)",{"count":561,"type":22},30,[25],"The study is to evaluate the feasibility of using a non-invasive brain stimulation device in a sample of inpatients with eating disorders (ED). The study will help researchers evaluate whether their device protocol is practical for eating disorder inpatients as a way to manage eating disorder and anxiety symptoms. A secondary aim of the study is to evaluate preliminary effectiveness of the protocol for reducing pre-meal anxiety during the treatment, and explore effects on eating disorder symptoms over the course of the inpatient admission.",[565,30],"Eating Disorders",[567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582],"electrotherapy stimulation","Alpha-Stim AID","cranial electrotherapy stimulation","CES","meal anxiety","Non-invasive cranial electrotherapy stimulation","Inpatient weight restoration","avoidant restrictive food intake disorder","other specified feeding or eating disorder","anorexia nervosa","bulimia nervosa","purging disorder","binge eating disorder","ARFID","OSFED","procedural anxiety",{"date":383,"type":43},{"date":585,"type":43},"2025-06-03",{"date":587,"type":22},"2027-11-01",{"name":589,"class":50},"Rogers Behavioral Health",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":51},"100577649","phase-2-trips---treatment-to-improve-depression-andor-anxiety-using-psilocybin-assisted-psychotherapy-in-cancer-survivors-100577649","NCT06801041","TRIPS - Treatment to Improve Depression and\u002For Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","Inclusion Criteria:\n\n1. Subjects must have solid or hematological malignancy that does not involve the brain.\n2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months\n3. Age ≥ 18 years.\n4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder, Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnoses are determined by. an MD Anderson licensed healthcare provider with graduate-level profession training and clinical experience in psychotherapy, licensed to practice independently.\n5. Have an ECOG performance status of 0, 1, or 2.\n6. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n7. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n8. Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.\n9. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Patient tested positive for a prescribed substance are eligible. Patient failing on the 2nd test (UDS) will be excluded.\n10. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n11. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n12. Eligible subjects will have a third-party transportation by a licenses driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n13. Fluent in Englishria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n\nExclusion Criteria:\n\n1. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self injurious behavior\n2. History of bipolar disorder, psychosis (including a history of schizophrenia).\n3. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n4. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n5. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n6. Documentation of current malignancy that is being treated with palliative intent.\n7. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n8. Patients with brain metastases.\n9. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \\>blood pressure \\>180\u002F120mmHG, HR \\>110 bpm . Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n10. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n11. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm on imaging ii. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a one-time febrile seizure in childhood iii. History of stroke in the past 3 years iv. Untreated cerebral aneurysm v. Dementia vi. Ongoing delirium in which subjects would not have the capacity to participate in the study.\n\n12 a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort) viii. efavirenz f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\ni. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\nii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\niii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\niv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\ng. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin.\n\nh. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\ni. Have an allergy or intolerance to any of the materials contained in the drug product.\n\nj. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and\u002For existential distress (e.g., pharmacologic or psychotherapeutic interventions).\n\n13\\. Patients with non-fMRI compatible implants will be eligible but will not have fMRI.",{"count":84,"type":22},[450],"This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and\u002For anxiety.",[269,30,600],"Cancer",{"date":383,"type":43},{"date":603,"type":43},"2025-05-23",{"date":605,"type":22},"2029-03-31",{"name":607,"class":50},"M.D. Anderson Cancer Center",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":23,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":635,"leadSponsor":637,"locationsCount":51},"100651626","physician-vs-artificial-intelligence-counseling-before-elective-cesarean-delivery-a-randomized-controlled-trial-100651626","NCT07762534","Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial","A Randomized Controlled Trial Comparing Physician-Provided Versus Artificial Intelligence-Based Preoperative Counseling Before Elective Cesarean Delivery","CAI-CS","Inclusion Criteria:\n\n* Women aged 18 years or older\n* Singleton pregnancy\n* Third trimester of pregnancy\n* Scheduled for elective cesarean delivery\n* Full proficiency in written and spoken Hebrew\n\nExclusion Criteria:\n\n* Non-elective cesarean delivery (urgent or emergency cesarean delivery) that does not allow completion of the counseling process and study questionnaires\n* Known anxiety disorder or depression\n* Cognitive impairment\n* Insufficient Hebrew language proficiency to independently complete study questionnaires\n* Multiple gestation pregnancy\n* Known fetal anomaly or significant fetal pathology diagnosed before delivery",{"count":617,"type":22},50,[25],"This randomized controlled trial will compare two methods of providing preoperative counseling before elective cesarean delivery: counseling by an obstetrician-gynecologist and counseling delivered through an artificial intelligence (AI)-based system. The study aims to evaluate the effects of these counseling methods on patients' anxiety levels, understanding of medical information, and satisfaction with the counseling process.\n\nWomen scheduled for elective cesarean delivery will be randomly assigned to receive either standard physician counseling or AI-based counseling containing the same medical information. Anxiety, knowledge, and satisfaction will be assessed using questionnaires before and after counseling.",[621,622,30],"Cesarean Section","Informed Consent",[624,621,625,626,622,627,628,30,629,630,631,38],"Elective Cesarean Delivery","Artificial Intelligence","AI Counseling","Preoperative Counseling","Patient Education","STAI","Shared Decision Making","Patient Satisfaction","2026-08-08",{"date":356,"type":43},{"date":104,"type":22},{"date":636,"type":22},"2027-08-01",{"name":638,"class":639},"Wolfson Medical Center","OTHER_GOV",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":647,"minAge":648,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":655,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":51},"100651440","structured-periprocedural-nursing-interventions-in-men-undergoing-transrectal-prostate-biopsy-100651440","NCT07760688","Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy","Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification","Inclusion Criteria:\n\n* Male participants aged 40 years or older.\n* Scheduled for transrectal ultrasound-guided prostate biopsy because of suspected prostate cancer.\n* Able to understand the study procedures and provide written informed consent.\n* Willing to complete all study assessments during the follow-up period.\n\nExclusion Criteria:\n\n* Inabillity to provide informed consent.\n* Severe cognitive impairment or psychiatric disorder preventing questionnaire completion.\n* Previous disgnosis of prostate cancer.\n* Inabillity to complete follow-up assessments.\n* Withdrawal of informed consent at any time.","MALE","40 Years",{"count":650,"type":22},120,[25],"This prospective longitudinal interventional study aims to evaluate the effect of structured peri-procedural nursing interventions on resilience and anxiety in men undergoing transrectal prostate biopsy. Participants will receive a standardized nursing intervention before and after the biopsy procedure. Resilience, anxiety, pain, lower urinary tract symptoms, and perceived nursing support will be assessed at predefined time points. Histopathological findings (benign or malignant) will be used for subgroup analyses. The study is conducted at the University Clinical Hospital Mostar, Bosnia and Herzegovina.",[30,654],"Biopsy",[656,657,658,659,660,661,662,663,664],"Prostate biopsy","Resilience","Nursing Intervention","Periprocedural nursing care","Prostate cancer","Patient education","Lower urinary tract symptoms","Hamilton Anxiety Rating Scale","International Prostate Symptom Score","2026-08-07",{"date":383,"type":43},{"date":668,"type":43},"2026-08-04",{"date":670,"type":22},"2027-08-04",{"name":672,"class":50},"University of Mostar",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":680,"enrollmentInfo":681,"targetDuration":4,"studyType":23,"phases":683,"briefSummary":684,"conditions":685,"keywords":686,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":690,"leadSponsor":692,"locationsCount":51},"100624910","effect-of-ctbs-on-startle-and-tms-evoked-bold-100624910","NCT07415772","Effect of cTBS on Startle and TMS-evoked BOLD","The Effect of Right dlPFC cTBS on Acute Measures of Anxiety, Functional Connectivity, and TMS-evoked BOLD Responses.","Inclusion Criteria:\n\n* Able to give their consent\n* Right-handed\n* Individuals receiving therapy for anxiety must be stable on their regimen for at least 4 weeks prior to study enrollment.\n\nExclusion Criteria:\n\n* Non-english speaking\n* Any significant medical or neurological problems\n* Current or past non-anxiety-related psychiatric comorbidity, active or history of active suicidal ideation\n* Alcohol\u002Fdrug problems in the past year or lifetime alcohol or drug dependence\n* Medications that act on the central nervous system\n* History of seizure\n* History of epilepsy\n* Increased risk of seizure for any reason\n* Pregnancy, or positive pregnancy test\n* Any medical condition that increases risk for fMRI or TMS\n* Any metal in their body which would make having an MRI scan unsafe\n* Any sort of medical implants\n* Hearing loss\n* Claustrophobia\n* orthostatic hypotension","50 Years",{"count":682,"type":22},140,[25],"The right dorsolateral prefrontal cortex (dlPFC) is increasingly being targeted with transcranial magnetic stimulation (TMS) to reduce anxiety expression; however, there is little mechanistic evidence supporting an optimized treatment protocol. Thus, the objective of the current project is to develop an interleaved TMS\u002FfMRI that can assess the effect of neuromodulatory (potentially therapeutic) TMS protocols on neural and behavioral measures related to anxiety expression. PUBLIC HEALTH RELEVANCE: These results will yield direct evidence that 1 Hz and cTBS modulate brain activity associated with anxiety expression and regulation, thus informing novel TMS based anxiety treatments.",[30],[191,687],"transcranial magnetic stimulation",{"date":494,"type":43},{"date":228,"type":22},{"date":691,"type":22},"2031-06-30",{"name":693,"class":50},"University of Pennsylvania",{"id":695,"slug":696,"hasResults":12,"nctId":697,"briefTitle":698,"officialTitle":699,"acronym":4,"eligibilityCriteria":700,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":118,"enrollmentInfo":701,"targetDuration":4,"studyType":23,"phases":702,"briefSummary":703,"conditions":704,"keywords":709,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":719,"lastUpdatePostDateStruct":720,"startDateStruct":721,"completionDateStruct":722,"leadSponsor":724,"locationsCount":51},"100650926","latin-dance-and-psychological-health-in-primary-school-children-100650926","NCT07755995","Latin Dance and Psychological Health in Primary School Children","Effects of Latin Dance Intervention on Psychologic Health, Loneliness, Enjoyment and Well-being Among Primary School Children in Gansu, China","Inclusion Criteria:\n\n* Primary school children aged 6-12 years.\n* Currently enrolled in a participating primary school in Gansu, China.\n* Able to participate safely in school-based physical activities and Latin dance sessions.\n* Able to understand and complete the study questionnaires.\n* Willing to participate in the 12-week intervention and study assessments.\n* Written informed consent provided by a parent or legal guardian.\n* Assent provided by the child.\n\nExclusion Criteria：\n\n* A medical condition, physical disability, or musculoskeletal injury that would make participation in physical activity or Latin dance unsafe.\n* A health condition for which a physician or school health professional advises against participation in moderate-intensity physical activity.\n* Current participation in regular Latin dance training or another structured dance intervention.\n* Participation in another psychological or physical activity intervention that may affect the study outcomes.\n* Inability to participate regularly in the intervention sessions or complete the study assessments.",{"count":478,"type":22},[25],"This study aims to examine the effects of a 12-week Latin dance intervention on loneliness, anxiety, depression, perceived stress, physical activity enjoyment, and well-being among primary school children in Gansu, China. Eligible participants will be randomly assigned to either a Latin dance intervention group or a control group. The intervention group will participate in two supervised Latin dance sessions per week, including Rumba, Cha-cha, and Jive, while the control group will participate in regular physical education activities. The outcomes will be assessed before and after the 12-week intervention using validated questionnaires. The findings may provide evidence regarding the effectiveness of school-based Latin dance as a strategy for promoting children's psychological health and well-being.",[705,30,269,706,707,708],"Loneliness","Stress","Well-Being","Enjoyment",[710,711,712,89,713,714,715,707,716,717,718],"Latin Dance","Primary School Children","School-Based Intervention","Physical Activity Enjoyment","Psychological Health","Mental Health","Rumba","Cha-Cha","Jive","2026-08-06",{"date":494,"type":43},{"date":228,"type":22},{"date":723,"type":22},"2026-11-30",{"name":725,"class":50},"Xu Shuishui"]