[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646349":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":41,"interventions":59,"overallOfficials":74,"centralContacts":86,"locations":96,"responsibleParty":135,"collaborators":33,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":33,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":164,"whyStopped":33,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":33},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Child Dental Anxiety (Self-Report)","Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.","Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)",{"measure":14,"description":15,"timeFrame":16},"Child Dental Anxiety (Observation-based Assessment)","Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).","Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction",{"measure":18,"description":19,"timeFrame":20},"3a: Physiological Monitoring - Pulse Rate","Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age:\n\nPreschool children (3-5 years): \\~80-120 bpm\n\nSchool-aged children (6-12 years): \\~70-118 bpm\n\nAdolescents (13-18 years): \\~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).","Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction",{"measure":22,"description":23,"timeFrame":20},"3b: Physiological Monitoring - Oxygen Saturation (SpO₂)","Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).",[25,29],{"measure":26,"description":27,"timeFrame":28},"Pain Perception (Self-Report)","Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version). This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome)","at the end of the procedure",{"measure":30,"description":31,"timeFrame":32},"Child Behavior (Observation)","Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:\n\n1. (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism.\n2. (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced.\n3. (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation.\n4. (Definitely Positive): Good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation.\n\nThe total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome).","Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.","SUPPORTIVE_CARE",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE",[42,48,54],{"label":43,"type":44,"description":45,"interventionNames":46},"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",[47],"Device: Virtual reality headset",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Behavioral: Audio-visual distraction with 2D cartoons",{"label":55,"type":50,"description":56,"interventionNames":57},"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.",[58],"Behavioral: Tell-show-do with verbal distraction",[60,65,70],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":33},"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.",[43],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":33},"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.",[49],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":33},"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.",[55],[75,79,82],{"name":76,"affiliation":77,"role":78},"Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd)","Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,","STUDY_DIRECTOR",{"name":80,"affiliation":81,"role":78},"Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd)","Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services",{"name":83,"affiliation":84,"role":85},"Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI)","Oman Medical Specialty Boaered","PRINCIPAL_INVESTIGATOR",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":33,"email":91},"Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)","CONTACT","+96895573313","zalqulhati@gmail.com",{"name":93,"role":89,"phone":94,"phoneExt":33,"email":95},"Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)","+96895692669","azzak@squ.edu.om",[97,119],{"facility":98,"status":33,"city":99,"state":33,"zip":33,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Sultan Qaboos University Hospital - Dental & Maxillofacial Department","Muscat","Oman","OM",{"type":103,"coordinates":104},"Point",[105,106],58.40778,23.58413,{"lat":106,"lon":105},[109,112,116],{"name":110,"role":89,"phone":94,"phoneExt":33,"email":111},"Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)","Azzak@squ.edu.om",{"name":113,"role":89,"phone":114,"phoneExt":33,"email":115},"Mohammed AlAzki, DSA","+968-97674606","m.alazki@squ.edu.om",{"name":117,"role":118,"phone":33,"phoneExt":33,"email":33},"Mohammed AlAzki, Diploma in Dental Surgery Assi","SUB_INVESTIGATOR",{"facility":120,"status":33,"city":99,"state":33,"zip":33,"country":100,"countryCode":101,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"The Medical City of Military and Security Service (Dental Center-AlKhoudh )",{"type":103,"coordinates":122},[105,106],{"lat":106,"lon":105},[125,129,133],{"name":126,"role":89,"phone":127,"phoneExt":33,"email":128},"Dr.Khalifa AlAzri, DclinDent (Ed), MPaeds (RCSEd)","+968-98199877","Khalifaazri_omsb@outlook.com",{"name":130,"role":89,"phone":131,"phoneExt":33,"email":132},"Majid AlFori, DSA","00968-99668984","Superhero-9w8@gmail.com",{"name":134,"role":118,"phone":33,"phoneExt":33,"email":33},"Majid AlFori, Diploma in Dental Surgery Assi",{"type":136,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"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":149,"type":150},168,"ESTIMATED","INTERVENTIONAL",[153],"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).",[156,157],"Dental Anxiety in Children","Pain Perception",[159,160,161,162,163],"pediatric dentistry","dental anxiety","tooth extraction","virtual reality","VR","NOT_YET_RECRUITING","2026-07-03",{"date":167,"type":168},"2026-07-09","ACTUAL",{"date":170,"type":150},"2026-09-01",{"date":172,"type":150},"2027-10-01",{"name":5,"class":6},2]