[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658352":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":46,"studyPopulation":35,"armGroups":47,"interventions":69,"overallOfficials":83,"centralContacts":88,"locations":97,"responsibleParty":110,"collaborators":35,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":35,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":35,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":99,"whyStopped":35,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Bezmialem Vakif University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":35},[9,13,17,21,24,28,32],{"measure":10,"description":11,"timeFrame":12},"Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score","Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The total score ranges from 15 to 75, with higher scores indicating greater dental fear and anxiety.","During the dental examination session, before dental treatment.",{"measure":14,"description":15,"timeFrame":16},"Facial Image Scale (FIS) Score","Dental anxiety will be assessed using the Facial Image Scale (FIS), a 5-point facial image scale ranging from 1 to 5, with higher scores indicating greater dental anxiety. FIS scores will be recorded at three time points: immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.","Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.",{"measure":18,"description":19,"timeFrame":20},"Frankl Behavior Rating Scale Score","Child behavior and cooperation during dental treatment will be assessed using the Frankl Behavior Rating Scale, which categorizes behavior into four levels ranging from definitely negative to definitely positive.","Immediately before dental treatment ande immediately after dental treatment.",{"measure":22,"description":23,"timeFrame":16},"FLACC Behavioral Pain Assessment Score","Pain-related behavioral responses will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral response. Assessment will be performed by an independent evaluator blinded to group allocation using standardized video recordings.",{"measure":25,"description":26,"timeFrame":27},"Wong-Baker FACES Pain Rating Scale Score","Self-reported pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.","Immediately before and immediately after local anesthetic injection.",{"measure":29,"description":30,"timeFrame":31},"Heart Rate","Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.","Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.",{"measure":33,"description":34,"timeFrame":31},"Peripheral Oxygen Saturation (SpO₂)","Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as percentage (%).",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","\"A four-arm, prospective, randomized, single-blind clinical trial.\"","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":43,"whoMasked":44},"SINGLE","The study employs a single-blind design focused on objective clinical evaluation. While participants and the primary investigator cannot be masked due to the nature of the interventions (VR and weighted blankets), the outcome assessment will be blinded. Video recordings of the dental procedures will be analyzed by an independent researcher who is blinded to the intervention group assignments. This independent assessor will use the FLACC (Face, Legs, Activity, Cry, Consolability) scale to evaluate behavioral stress responses and discomfort, thereby minimizing potential observer bias.",[45],"OUTCOMES_ASSESSOR","This clinical trial is designed as a four-arm, randomized controlled study to compare sensory-based behavior guidance techniques in pediatric dentistry.\n\nStudy Arms:\n\nGroup 1 (Control): Treatment with basic behavior guidance techniques.\n\nGroup 2 (VR): Treatment using virtual reality (VR) glasses as a distraction tool.\n\nGroup 3 (WB): Treatment using a 3-kg weighted blanket for deep-pressure stimulation.\n\nGroup 4 (Combined): Simultaneous use of VR glasses and a weighted blanket.\n\nMethodology:\n\nChildren aged 5-9 years who meet the inclusion criteria will be evaluated at multiple time points: pre-treatment, during local anesthesia, and post-treatment.\n\nOutcome Measures:\n\nDental Anxiety: Assessed using the Facial Image Scale (FIS) and the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).\n\nCooperation: Evaluated using the Frankl Behavior Rating Scale and the FLACC (Face, Legs, Activity, Cry, Consolability) scale.\n\nPain Perception: Measured using the Wong-Baker FACES Pain Rating Scale.\n\nPhysiological Parameters: Heart rate and oxygen saturation will be monitored throughout the procedure.\n\nAcceptability: Subjective feedback from children and parents will be collected via post-treatment surveys to assess the feasibility of and satisfaction with the interventions.\n\nInclusion is restricted to systemically healthy children (ASA I-II) whose body weight (15-30 kg) is compatible with the 3-kg weighted blanket to ensure safety and appropriate therapeutic pressure.",[48,54,60,65],{"label":49,"type":50,"description":51,"interventionNames":52},"Control Group","ACTIVE_COMPARATOR","Participants in this group will receive dental treatment using only basic behavior guidance techniques, such as tell-show-do and positive reinforcement, without any additional sensory interventions.",[53],"Other: Basic Behavior Guidance",{"label":55,"type":56,"description":57,"interventionNames":58},"Virtual Reality Group","EXPERIMENTAL","Participants will wear virtual reality (VR) glasses during the dental procedure. The VR system will be used as a visual and auditory distraction tool to reduce dental anxiety and pain perception.",[59],"Device: Virtual Reality Distraction",{"label":61,"type":56,"description":62,"interventionNames":63},"Weighted Blanket Group","Participants will be covered with a 3-kg weighted blanket during the dental procedure to provide deep-pressure stimulation. This non-pharmacological intervention aims to promote relaxation and reduce physiological stress responses.",[64],"Other: Deep Pressure Stimulation",{"label":66,"type":56,"description":67,"interventionNames":68},"Combined Intervention Group","Participants in this group will receive a combination of the two interventions during the entire dental procedure: virtual reality (VR) glasses for distraction and a weighted blanket for deep-pressure stimulation.",[64,59],[70,74,78],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":35},"Basic Behavior Guidance","Traditional non-pharmacological behavior management techniques, including the \"Tell-Show-Do\" method, positive reinforcement, and distraction through verbal communication, will be used as a standard protocol.",[49],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":35},"Deep Pressure Stimulation","A 3 kg weighted blanket will be placed over the participant's body during the dental treatment. This intervention aims to provide deep pressure stimulation to promote relaxation and decrease behavioral stress responses.",[66,61],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":35},"DEVICE","Virtual Reality Distraction","The participant will wear a Virtual Reality headset during the dental procedure. Audio-visual content specifically selected for pediatric distraction will be played to divert the child's attention away from dental stimuli and reduce anxiety.",[66,55],[84],{"name":85,"affiliation":86,"role":87},"Mustafa Sarp Kaya, Associate Professor","Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry","PRINCIPAL_INVESTIGATOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":35,"email":93},"Ayşe Evirken, DDS","CONTACT","+90 543 927 76 86","ayse.evirken@bezmialem.edu.tr",{"name":85,"role":91,"phone":95,"phoneExt":35,"email":96},"+90 532 230 68 01","mskaya@bezmialem.edu.tr",[98],{"facility":86,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":35,"cosmosGeoPoint":104,"geoPoint":109,"contacts":35},"RECRUITING","Istanbul","Fatih","34093","Turkey (Türkiye)",{"type":105,"coordinates":106},"Point",[107,108],28.94966,41.01384,{"lat":108,"lon":107},{"type":87,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Mustafa Sarp Kaya","Associate Professor, Department of Pediatric Dentistry","100658352","multisensory-approaches-for-managing-pediatric-dental-anxiety-100658352",false,"NCT07848542","Multisensory Approaches for Managing Pediatric Dental Anxiety","Evaluation of the Effects of Virtual Reality and Weighted Blanket Use on Dental Anxiety Among School-Aged Children With High Dental Anxiety","Inclusion Criteria:\n\n* Children aged between 5 and 9 years.\n* Children with a total score of 39 or higher on the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).\n* Requirement for dental treatment necessitating local anesthesia, such as Class II restorations, pulpotomy, pulpectomy, or extractions.\n* Systemically healthy children classified as ASA I or ASA II.\n* Voluntary participation of both the child and the parent, with written informed consent obtained from the parent.\n* Body weight between 15 and 30 kg, ensuring that the 3-kg weighted blanket corresponds to 10-20% of the child's body weight.\n\nExclusion Criteria:\n\n* Children with a CFSS-DS score of 38 or lower.\n* Presence of intellectual or developmental disabilities.\n* Presence of visual or hearing impairments.\n* Presence of neurodevelopmental or neurological disorders, such as epilepsy.\n* Acute or chronic respiratory diseases.\n* Neuromuscular or orthopedic conditions that may pose a risk during the use of the weighted blanket.\n* History of dizziness, nausea, or vertigo associated with virtual reality use.\n* Refusal of the specific interventions, namely VR glasses or the weighted blanket, by the child or the parent.",true,"ALL","5 Years","9 Years",{"count":125,"type":126},60,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this prospective, randomized, single-blind clinical study is to evaluate and compare the effectiveness of distraction using virtual reality (VR) glasses and deep-pressure stimulation using weighted blankets on dental anxiety, cooperation, and pain perception in school-aged children. The study focuses on children aged 5-9 years with high dental anxiety (CFSS-DS score ≥39) who require dental procedures involving local anesthesia, such as Class II restorations, pulpotomy, or extractions. Participants will be randomly assigned to four groups: a control group receiving standard behavior guidance, a VR group, a weighted blanket group, and a combined group using both VR and weighted blankets. The study aims to determine the effects of these non-pharmacological, non-invasive, sensory-based interventions on children's clinical experience and physiological parameters.",[132,133],"Pediatric Dental Anxiety","Dental Anxiety",[135,136,137,138,139,140],"virtual reality","weighted blanket","deep pressure stimulation","distraction techniques","behavior guidance","pediatric dentistry","2026-09-23",{"date":143,"type":144},"2026-09-30","ACTUAL",{"date":146,"type":144},"2026-08-19",{"date":148,"type":126},"2027-04",{"name":5,"class":6},1]