[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646349":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":53,"locations":63,"responsibleParty":102,"collaborators":31,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":31,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":131,"whyStopped":31,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Virtual Reality Distraction","EXPERIMENTAL","Children wear VR glasses to watch immersive 3D cartoons during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters",[13],"Device: Virtual reality headset",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Audio-Visual Distraction","ACTIVE_COMPARATOR","Children watch 2D cartoons with headset during dental extraction. Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group.",[19],"Behavioral: Audio-visual distraction with 2D cartoons",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 3: Conventional Tell-Show-Do","Children receive the standard tell-show-do technique with verbal distraction during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters.",[24],"Behavioral: Tell-show-do with verbal distraction",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Virtual reality headset","Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"BEHAVIORAL","Audio-visual distraction with 2D cartoons","Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.",[15],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Tell-show-do with verbal distraction","Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.",[21],[42,46,49],{"name":43,"affiliation":44,"role":45},"Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd)","Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,","STUDY_DIRECTOR",{"name":47,"affiliation":48,"role":45},"Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd)","Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services",{"name":50,"affiliation":51,"role":52},"Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI)","Oman Medical Specialty Boaered","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":31,"email":58},"Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)","CONTACT","+96895573313","zalqulhati@gmail.com",{"name":60,"role":56,"phone":61,"phoneExt":31,"email":62},"Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)","+96895692669","azzak@squ.edu.om",[64,86],{"facility":65,"status":31,"city":66,"state":31,"zip":31,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Sultan Qaboos University Hospital - Dental & Maxillofacial Department","Muscat","Oman","OM",{"type":70,"coordinates":71},"Point",[72,73],58.40778,23.58413,{"lat":73,"lon":72},[76,79,83],{"name":77,"role":56,"phone":61,"phoneExt":31,"email":78},"Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)","Azzak@squ.edu.om",{"name":80,"role":56,"phone":81,"phoneExt":31,"email":82},"Mohammed AlAzki, DSA","+968-97674606","m.alazki@squ.edu.om",{"name":84,"role":85,"phone":31,"phoneExt":31,"email":31},"Mohammed AlAzki, Diploma in Dental Surgery Assi","SUB_INVESTIGATOR",{"facility":87,"status":31,"city":66,"state":31,"zip":31,"country":67,"countryCode":68,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"The Medical City of Military and Security Service (Dental Center-AlKhoudh )",{"type":70,"coordinates":89},[72,73],{"lat":73,"lon":72},[92,96,100],{"name":93,"role":56,"phone":94,"phoneExt":31,"email":95},"Dr.Khalifa AlAzri, DclinDent (Ed), MPaeds (RCSEd)","+968-98199877","Khalifaazri_omsb@outlook.com",{"name":97,"role":56,"phone":98,"phoneExt":31,"email":99},"Majid AlFori, DSA","00968-99668984","Superhero-9w8@gmail.com",{"name":101,"role":85,"phone":31,"phoneExt":31,"email":31},"Majid AlFori, Diploma in Dental Surgery Assi",{"type":103,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100646349","evaluation-of-virtual-reality-based-distraction-on-anxiety-and-pain-perception-in-paediatric-dental-extraction-100646349",false,"NCT07693764","Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction","\"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial\"","VR-PED","Inclusion Criteria:\n\n* Children aged 6 to 10 years\n* Classified as ASA class 1 or 2 (healthy or with mild systemic disease)\n* Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures\n* Children with NO previous exposure to invasive dental procedure\n* No prior experience using VR glasses\n* Requiring extraction of mandibular deciduous molar under local anesthesia\n\nExclusion Criteria:\n\n* ASA 3 and above\n* Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures\n* Special needs ( intellectual and developmental)\n* Children on psychotropic medication\n* Children wearing glasses\n* Presence of intra-oral swelling","ALL","6 Years","10 Years",{"count":116,"type":117},168,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:\n\nDoes virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?\n\nDoes virtual reality distraction reduce pain perception during dental extraction?\n\nResearchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.\n\nParticipants will:\n\nWear VR glasses to watch immersive 3D cartoons, or\n\nWatch 2D cartoons with headset, or\n\nReceive the conventional tell-show-do technique with verbal distraction.\n\nOutcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).",[123,124],"Dental Anxiety in Children","Pain Perception",[126,127,128,129,130],"pediatric dentistry","dental anxiety","tooth extraction","virtual reality","VR","NOT_YET_RECRUITING","2026-07-03",{"date":134,"type":135},"2026-07-09","ACTUAL",{"date":137,"type":117},"2026-09-01",{"date":139,"type":117},"2027-10-01",{"name":5,"class":6},2]