[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643391":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":28,"studyPopulation":22,"armGroups":29,"interventions":41,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":78,"collaborators":22,"id":80,"slug":22,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":22,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":22,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":65,"whyStopped":22,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Damascus University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Heart Rate","Assessment tool: Pulse oximeter Measurement unit: Beats per minute (bpm)\n\nAssessment time points:\n\nHeart rate was assessed during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.","during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.",{"measure":14,"description":15,"timeFrame":16},"Facial Image Scale (FIS)","Assessment tool: Facial Image Scale questionnaire Measurement unit: Ordinal score (1-5)\n\nAssessment time points:\n\nFacial Image Scale was assessed during a single dental treatment visit at baseline and during treatment.","The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.",[18],{"measure":19,"description":20,"timeFrame":21},"Oxygen Saturation (SpO₂)","Assessment tool: Pulse oximeter Measurement unit: Percentage (%)\n\nAssessment time points:\n\nOxygen saturation was measured using a pulse oximeter and recorded during a single dental treatment visit at baseline, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during dental treatment.","Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":6,"observationalModel":22,"timePerspective":22,"maskingInfo":26},"RANDOMIZED","PARALLEL",{"masking":27,"maskingDescription":22,"whoMasked":22},"NONE","Dental fear and anxiety in children are associated with several visual stimuli, such as the shape of the dental handpiece or saliva ejector, as well as painful procedures like local anaesthesia, which may create a barrier to receiving dental treatment. Many studies have explored various behaviour management techniques to reduce anxiety during treatment; however, few have investigated the effect of using a video simulation of the real oral environment to familiarise children with treatment steps and reinforce the phrases commonly used by the dentist. This study was designed to reassure children by using a video that demonstrates carious lesions and dental instruments, including the mirror, saliva ejector, handpiece, and syringe, and shows how they work inside the mouth in a child-friendly manner.\n\nThis research is a randomised controlled clinical trial in which participants were assigned to two groups based on the behaviour management technique used. Anxiety was assessed using three integrated measures: a self-reported anxiety scale, an observer-rated behaviour scale, and physiological indicators including oxygen saturation and heart rate. All measures were recorded before, during, and after treatment to provide a comprehensive evaluation of the intervention's effect on children's anxiety levels.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Tell-Show-Do behavior management technique","ACTIVE_COMPARATOR","Children in this group will receive restorative treatment with following the traditional TSD technique without any visual aids.",[35],"Behavioral: Behavioral Treatment",{"label":37,"type":38,"description":39,"interventionNames":40},"Real-Oral Simulation Video-Assisted Tell-Show-Do Technique","EXPERIMENTAL","Children in this group will receive restorative treatment with following the enhanced Tell-Show-Do technique with a video simulating the real oral environment",[35],[42,49],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","Behavioral Treatment","This group received treatment guided by the Tell-Show-Do (TSD) method. Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.' After the explanation and instrument demonstration, restorative treatment was carried out. The protocol excluded the use of any audiovisual aids. All procedures involved conservative restoration of the mandibular primary molars",[31],[48],"Tell-Show-Do Technique",{"type":43,"name":44,"description":50,"armGroupLabels":51,"otherNames":52},"Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation. Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task. The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal. Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape. These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation. Each viewing was followed by a standardized verbal explanation before performing the clinical procedure. All participants underwent conservative restorative treatment of the mandibular primary molars",[37],[37],[54],{"name":55,"affiliation":5,"role":56},"Chaza Kouchaji","STUDY_DIRECTOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":22,"email":62},"Rana Soleman","CONTACT","+963 934 966 599","drranasoliman66@gmail.com",[64],{"facility":5,"status":65,"city":66,"state":22,"zip":22,"country":67,"countryCode":22,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Damascus","Syria",{"type":69,"coordinates":70},"Point",[71,72],36.29128,33.5102,{"lat":72,"lon":71},[75],{"name":76,"role":60,"phone":77,"phoneExt":22,"email":62},"Rana Soliman","+963 934 966 599drranasoliman6",{"type":79,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100643391",false,"NCT07632547","Video-Enhanced Tell-Show-Do for Managing Dental Anxiety in Children","Reinforcing the Tell-Show-Do Technique With a Simulated Real-mouth Video to Manage Dental Anxiety in Children During Dental Treatment (A Randomized Controlled Trial)","Inclusion Criteria:\n\n1. Children aged 4-6 years, with or without previous dental experience.\n2. Children with a positive behavior rating according to the Frankl scale.\n3. Children with primary molars requiring conservative dental treatment.\n\nExclusion Criteria:\n\n1. Children with systemic or mental disorders.\n2. Children who received sedative or analgesic medications within the 3 hours prior to the dental visit.",true,"ALL","4 Years","6 Years",{"count":91,"type":92},80,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study is the first of its kind to examine the effect of integrating the real oral environment with a video that supports the expressions used during the Tell-Show-Do technique (such as \"we will see the cavity,\" \"the cavity will drink juice to fall asleep,\" and \"we will clean the tooth from the cavity\"). This approach aims to enhance the Tell-Show-Do technique, build trust with the child, and reduce anxiety at the different stages of dental treatment in the clinical setting.",[98,99],"Distraction","Behavior Management",[101,102,103],"Dental anxiety","Video modeling \u002F Simulation","Tell-Show-Do technique","2026-06-02",{"date":106,"type":107},"2026-06-08","ACTUAL",{"date":109,"type":107},"2026-04-01",{"date":111,"type":92},"2026-08-01",{"name":5,"class":6},1]