[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"randomized-controlled-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:randomized-controlled-study":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"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":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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",false,"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.",true,"ALL","5 Years","10 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31,32,33],"Anxiety","Fear","Multisensory Stimulation","Pediatric Surgery","Parental Anxiety","Randomized Controlled Study",[35,36,37,38,39],"anxiety","fear","parental anxiety","multisensory stimulation","pediatric surgery","NOT_YET_RECRUITING","2026-08-17",{"date":43,"type":44},"2026-08-19","ACTUAL",{"date":46,"type":22},"2026-07-29",{"date":48,"type":22},"2026-09-01",{"name":50,"class":51},"Bilecik Seyh Edebali Universitesi","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":16,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":52},"100610370","phase-3-suzetrigine-in-total-hip-arthroplasty-100610370","NCT07226700","Suzetrigine in Total Hip Arthroplasty","A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty","Inclusion Criteria:\n\n* Patients undergoing primary THA (posterior approach) with participating surgeons\n* Age 18 to 80 years old\n* Planned discharge to home\n* Planned use of neuraxial anesthesia\n* American Society of Anesthesiologists (ASA) Physical Status 1 - 3\n\nExclusion Criteria:\n\n* ASA greater than 3\n* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)\n* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)\n* History of QT prolongation\n* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device\n* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse\n* Inability to comply with any component of the study protocol\n* Younger than 18 or greater than 80 years old at the time of enrollment\n* Patient already on Suzetrigine\n* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease\u002FChild Pugh B or C, use of strong CYP3 inhibitors or inducers)\n* Contraindications to neuraxial anesthesia or any other part of the study protocol\n* Participation in another investigational drug or device study\n* Pregnancy","18 Years","80 Years",{"count":63,"type":22},210,[65],"PHASE3","Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,33,83],"Total Hip Arthroplasty (THA)","Total Hip Arthroplasty \\(THA\\)","Total Hip Replacement","Total Hip Replacement Surgery","Total Hip Replacements","Total Hip Replacement Arthroplasty","Suzetrigine","Pain Management","Pain","Nav 1.8","JOURNAVX","Opioid Cessation","Opioid Consumption, Postoperative","Multimodal Analgesia","Randomized Controlled Trial","Randomized Controlled Trials","RECRUITING",{"date":86,"type":44},"2026-07-30",{"date":88,"type":44},"2025-11-03",{"date":90,"type":22},"2028-11-01",{"name":92,"class":51},"Hospital for Special Surgery, New York",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100576944","nurture-and-play---a-pilot-study-100576944","NCT06791876","'Nurture and Play' - a Pilot Study","'Nurture and Play' - a Randomized Controlled Pilot Study of a Perinatal Intervention to Strengthen Parenting Among Women with Psychosocial Vulnerabilities and Their Partners.","Inclusion Criteria:\n\n* Known with a current or previous history of anxiety and\u002For depression\n* Referred for labour at Slagelse Hospital\n\nExclusion Criteria:\n\n* Age under 18 years old\n* A need for an interpreter\n* Expecting more than one child\n* Known with schizophrenia or other serious mental illness\n* Expecting a child with a known illness\n* A history of alcohol or drug abuse",{"count":101,"type":22},20,[25],"The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners.\n\nMore specifically the objectives of the study are to:\n\n* Test the feasibility of the NnP including both parents\n* Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention\n* Evaluate the collaboration between the hospitals and the municipalities.\n\nThe study consists of:\n\n1. A randomized controlled pilot study (n=20 women\u002Fcouples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers\u002Fcouples.\n2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.\n\nData will be collected through:\n\n* Online Questionnaires.\n* Interviews.\n* Videotaped settings.",[105,106,33],"Depression, Anxiety","Intervention","2025-01-24",{"date":109,"type":44},"2025-01-28",{"date":111,"type":22},"2025-02-15",{"date":113,"type":22},"2026-10-15",{"name":115,"class":116},"Center for Clinical Research and Prevention","NETWORK"]