[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627534":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":43,"overallOfficials":22,"centralContacts":53,"locations":59,"responsibleParty":72,"collaborators":22,"id":74,"slug":22,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":22,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":22,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":62,"whyStopped":22,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Saint-Joseph University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response","Heart rate will be measured using a pulse oximeter before and during local anesthesia administration to assess physiological anxiety response.","Immediately before and during local anesthesia administration (single visit)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Pain Perception During Local Anesthesia Administration","Pain will be assessed immediately after local anesthesia administration using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where 0 indicates \"no pain\" and 10 indicates \"worst pain possible.\" Higher scores represent greater perceived pain. Scores will be recorded and compared between the two groups.","Immediately after local anesthesia administration (same visit)",{"measure":19,"description":20,"timeFrame":21},"Child Behavioral Response During Local Anesthesia","Child behavior during local anesthesia will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale. The FLACC scale ranges from 0 to 10, with 0 indicating relaxed\u002Fcomfortable behavior and 10 indicating severe pain or distress. Higher scores represent greater behavioral distress or pain. Scores will be recorded during injection and compared between study groups.","During local anesthesia administration (same visit)",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","Dental anxiety is common among children, particularly during local anesthesia injections. The Tell-Show-Do (TSD) technique is widely used in pediatric dentistry to reduce fear by explaining and demonstrating procedures before performing them. However, its effectiveness may vary depending on communication style and child engagement. With increasing exposure to digital media, children may respond more positively to visual and technology-based tools.\n\nThis randomized controlled clinical trial will compare traditional TSD with an AI-driven avatar-based video modification (\"Mini Dentist\") during buccal infiltration anesthesia in children aged 5-7 years receiving local anesthesia for the first time. Eligible children will be randomly assigned (1:1) to:\n\n* Group A: Traditional Tell-Show-Do\n* Group B: AI-driven avatar-based Tell-Show-Do video\n\nAll injections will follow a standardized protocol and be performed by the same pediatric dentist to ensure consistency.\n\nPrimary outcome:\n\nPhysiological anxiety measured by heart rate at five standardized time points.\n\nSecondary outcomes:\n\n* Behavioral pain response assessed using the FLACC scale\n* Self-reported pain using the Wong-Baker FACES Pain Rating Scale\n\nBehavior during injection will be video recorded for objective scoring by calibrated evaluators.\n\nThe study is approved by the Research Ethics Committee of Saint Joseph University of Beirut. Participation is voluntary, and informed consent is obtained from parents or legal guardians.\n\nThe objective is to determine whether integrating AI-based behavioral preparation improves anxiety control and cooperation during pediatric dental injections.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"AI Avatar Video Group","EXPERIMENTAL","Participants in this group will watch an artificial intelligence-driven avatar-based video explaining the local anesthesia procedure before receiving the injection. The video presents the procedure in a child-friendly manner to reduce anxiety and improve cooperation during treatment.",[36],"Behavioral: AI Avatar-Based video",{"label":38,"type":39,"description":40,"interventionNames":41},"Tell-Show-Do Group","ACTIVE_COMPARATOR","Participants in this group will receive behavior management using the conventional Tell-Show-Do technique before administration of local anesthesia. The dentist will verbally explain, demonstrate, and then perform the procedure according to standard pediatric dental practice.",[42],"Behavioral: Tell-Show-Do Technique",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":22},"BEHAVIORAL","AI Avatar-Based video","A pre-recorded artificial intelligence-driven avatar-based educational video shown to children prior to administration of local anesthesia. The video explains the injection procedure in simple, age-appropriate language to reduce dental anxiety and improve cooperation.",[32],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":22},"Tell-Show-Do Technique","A conventional behavior management technique used in pediatric dentistry in which the dentist tells the child about the procedure, shows the instruments in a non-threatening way, and then performs the treatment. This method aims to reduce anxiety and improve cooperation during local anesthesia administration.",[38],[54],{"name":55,"role":56,"phone":57,"phoneExt":22,"email":58},"Rita Melekian, Pediatric dentistry resident","CONTACT","71\u002F895228","rita.melekian@net.usj.edu.lb",[60],{"facility":61,"status":62,"city":63,"state":22,"zip":22,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":22},"Sint Joseph University of Beirut- Pediatric Dentistry clinic","RECRUITING","Beirut","Lebanon","LB",{"type":67,"coordinates":68},"Point",[69,70],35.50157,33.89332,{"lat":70,"lon":69},{"type":73,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100627534",false,"NCT07449884","AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia","Artificial Intelligence-driven Avatar-based Video vs. Tell-show-do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  * Children aged 5 to 7 years\n  * Medically healthy (ASA I)\n  * Cooperative behavior during dental examination\n  * No known allergy to local anesthetics\n  * Require non-urgent dental treatment under local anesthesia\n  * First-time experience receiving local anesthesia\n  * Able to understand and communicate\n\nExclusion Criteria:\n\n* History of epilepsy\n* Diagnosed anxiety or behavioral disorders\n* Cognitive or developmental delay\n* Hearing or visual impairment\n* Previous experience with dental anesthesia\n* Require inferior alveolar nerve block anesthesia\n\nExclusion Criteria:\n\n\\-",true,"ALL","5 Years","7 Years",{"count":85,"type":86},70,"ESTIMATED","INTERVENTIONAL",[89],"NA","This randomized clinical trial aims to compare two behavior guidance techniques used to reduce anxiety in children during local anesthesia injections in dental treatment. The study evaluates the traditional Tell-Show-Do (TSD) technique versus an artificial intelligence (AI)-driven, avatar-based video method called the \"Mini Dentist.\"\n\nChildren aged 5 to 7 years who require local anesthesia for routine dental treatment will be randomly assigned to one of two groups. The control group will receive the conventional Tell-Show-Do explanation from the pediatric dentist. The experimental group will watch a short animated video featuring an AI-generated avatar that explains and demonstrates the procedure in a child-friendly manner before the injection.\n\nAnxiety and behavior will be assessed using heart rate monitoring, behavioral observation (FLACC scale), and a self-reported pain scale (Wong-Baker FACES). The goal is to determine whether the AI-based method improves cooperation and reduces anxiety compared to the traditional approach.\n\nParticipation is voluntary, and all procedures follow ethical research standards.",[92,93,94,95],"Anxiety","Fear","Local Anesthesia","Pediatric Dentistry",[97,98,99,100,101],"Artificial intelligence","Child behavior","Dental anxiety","Local anesthesia.","Randomized Controlled trial","2026-03-24",{"date":104,"type":105},"2026-03-30","ACTUAL",{"date":107,"type":105},"2026-02-16",{"date":109,"type":86},"2027-05-30",{"name":5,"class":6},1]