[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658566":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":32,"studyPopulation":21,"armGroups":33,"interventions":44,"overallOfficials":50,"centralContacts":58,"locations":63,"responsibleParty":78,"collaborators":21,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":21,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":21,"enrollmentInfo":90,"targetDuration":21,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"State Anxiety During Surgery Measured by the State-Trait Anxiety Inventory-State (STAI-S)","State anxiety associated with the surgical procedure will be assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S). The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Participants will self-complete the STAI-S within 5 minutes after the final suture as the standardized assessment of anxiety associated with the just-completed surgical procedure.","Within 5 minutes after the final suture on the day of surgery",[14,17],{"measure":15,"description":16,"timeFrame":12},"Pain During Surgery Measured by a 0-10 Numeric Rating Scale","Pain associated with the just-completed surgical procedure will be self-reported on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. The assessment will be completed within 5 minutes after the final suture.",{"measure":18,"description":19,"timeFrame":20},"Immediate Postoperative Satisfaction","Participant-reported satisfaction with the surgical experience will be assessed using a 0-10 numeric rating scale, with higher scores indicating greater satisfaction.","Within 5 minutes after completion of surgery",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Two-arm parallel-group randomized controlled trial comparing immersive virtual reality plus standard surgical care with standard surgical care alone. Randomization is stratified by baseline STAI-T and uses covariate-adaptive minimization with a biased-coin probability of 0.80\u002F0.20 to balance MDAS, age, and sex.","SUPPORTIVE_CARE",{"masking":28,"maskingDescription":29,"whoMasked":30},"SINGLE","Participants and operating surgeons cannot be masked because of the nature of the virtual reality intervention. Outcome assessment staff are masked to treatment allocation. Self-reported questionnaires are completed by participants using standardized instructions and study data are coded to minimize disclosure of treatment allocation during outcome assessment and data handling.",[31],"OUTCOMES_ASSESSOR","This is a single-center, parallel-group randomized controlled trial involving 120 adults scheduled for surgical removal of a mandibular third molar. Eligible participants will be stratified according to baseline trait anxiety (STAI-T \\\u003C40 or ≥40). Within each stratum, treatment allocation will use a minimization procedure with a biased-coin probability of 0.80\u002F0.20 to improve balance between groups with respect to dental anxiety measured by the Modified Dental Anxiety Scale, age, and sex. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes.\n\nParticipants assigned to the experimental group will use an immersive virtual reality headset (Meta Quest 3) presenting relaxing natural scenery. The headset will be started approximately 2-3 minutes before administration of local anesthesia and will remain in use until completion of the final suture. Participants assigned to the control group will receive standard care without virtual reality.\n\nAll mandibular third molar surgeries will follow the same standardized surgical protocol. Participating surgeons will have at least 5 years of surgical experience and will receive protocol-specific training.\n\nState anxiety will be assessed before surgery and immediately after surgery, within 5 minutes after the final suture, with the post-surgical assessment referring to the participant's anxiety experienced during the procedure. Participants will also be followed for postoperative pain, facial swelling, maximum mouth opening, wound healing, sensory disturbances, analgesic consumption, and postoperative complications.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Immersive Virtual Reality","EXPERIMENTAL","Participants will receive immersive virtual reality using a Meta Quest 3 headset in addition to standardized surgical care during removal of a mandibular third molar",[39],"Device: Immersive Virtual Reality (Meta Quest 3)",{"label":41,"type":42,"description":43,"interventionNames":21},"Standard Care","NO_INTERVENTION","Participants will undergo the same standardized mandibular third molar surgical procedure without virtual reality beyond routine care",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":21},"DEVICE","Immersive Virtual Reality (Meta Quest 3)","Participants will wear a Meta Quest 3 virtual reality headset with integrated audio displaying relaxing natural scenery. The virtual reality intervention will begin approximately 2-3 minutes before administration of local anesthesia and will continue throughout the surgical procedure until completion of the final suture. The intervention may be discontinued if the participant experiences significant cybersickness, such as dizziness, nausea or discomfort",[35],[51,55],{"name":52,"affiliation":53,"role":54},"Van Thang Nguyen, DDS, MSc","The University of Danang - School of Medicine and Pharmacy","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":5,"role":57},"Duc Nguyen Minh, DDS, PhD","STUDY_CHAIR",[59],{"name":52,"role":60,"phone":61,"phoneExt":21,"email":62},"CONTACT","+84 849999942","drthangvan@gmail.com",[64],{"facility":65,"status":66,"city":67,"state":67,"zip":21,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"School of Dentistry, Hanoi Medical University","RECRUITING","Hanoi","Vietnam","VN",{"type":71,"coordinates":72},"Point",[73,74],105.84117,21.0245,{"lat":74,"lon":73},[77],{"name":52,"role":60,"phone":61,"phoneExt":21,"email":62},{"type":54,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"DUC NGUYEN MINH","Lecturer","100658566","virtual-reality-to-reduce-anxiety-in-adults-having-lower-wisdom-tooth-surgery-100658566",false,"NCT07853014","Virtual Reality to Reduce Anxiety in Adults Having Lower Wisdom Tooth Surgery","Effect of Immersive Virtual Reality on Anxiety During Surgical Removal of Mandibular Third Molars in Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\nAdults aged 18 years or older. Indication for surgical removal of a mandibular third molar. Mandibular third molar with a Pederson difficulty score of 5 or higher on panoramic radiography.\n\nGeneral health status permitting oral surgery, with no current acute infection, swelling or acute pain at the surgical site.\n\nAble and willing to provide written informed consent and comply with the study procedures and scheduled follow-up visits.\n\nExclusion Criteria:\n\nSevere psychiatric disorder, severe dizziness or a history of significant motion sickness that may interfere with use of virtual reality.\n\nSystemic medical conditions that do not permit surgical treatment, including uncontrolled cardiovascular disease, uncontrolled diabetes mellitus or current use of immunosuppressive medication.\n\nPregnancy or breastfeeding. Current or previous radiotherapy involving the maxillofacial region.","ALL","18 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"NA","This randomized controlled trial will evaluate whether immersive virtual reality can reduce anxiety in adults undergoing surgical removal of mandibular third molars under local anesthesia. A total of 120 participants will be assigned to either an immersive virtual reality group or a standard-care control group. Participants in the virtual reality group will use a Meta Quest 3 headset displaying relaxing natural scenery beginning 2-3 minutes before local anesthesia and continuing through completion of surgery. Both groups will undergo the same standardized surgical protocol. The primary outcome is state anxiety during surgery, assessed using the State-Trait Anxiety Inventory-State scale (STAI-S). Secondary outcomes include intraoperative pain and immediate postoperative satisfaction. Additional measures will assess postoperative pain, swelling, mouth opening, wound healing, analgesic use, adverse events and acceptability of virtual reality.",[98,99],"Dental Anxiety","Mandibular Third Molar",[101,99,102,103,104,35],"Virtual Reality","Third Molar Surgery","Oral Surgery","State-Trait Anxiety Inventory","2026-09-25",{"date":107,"type":108},"2026-10-01","ACTUAL",{"date":110,"type":108},"2026-06-09",{"date":112,"type":92},"2027-07-30",{"name":5,"class":6},1]