[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648166":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"October University for Modern Sciences and Arts","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL",null,[13],"Other: BrightHearts\"biofeedback relaxation tool",{"label":15,"type":16,"description":11,"interventionNames":17},"Group B","ACTIVE_COMPARATOR",[18],"Device: Virtual Reality distraction",{"label":20,"type":16,"description":11,"interventionNames":21},"Group C",[22],"Behavioral: Verbal distraction technique",[24,28,33],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"BrightHearts\"biofeedback relaxation tool","Before the inferior alveolar nerve block procedure, Participants will be taught to use the application after given instructions.\n\nThey will be asked to keep a constant color by focusing on breathing slowly, then they will be allowed to use the application a few minutes before the inferior alveolar nerve block procedure",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DEVICE","Virtual Reality distraction","participants in this group will experience Virtual Reality distraction eyewear. After giving an introduction about it, they will be allowed to accommodate, then they will be wearing it during the inferior alveolar nerve block procedure in an environment designed to distract them during the injection. The Virtual Reality distraction content will be age-appropriate and engaging, and feature interactive (e.g., Fun animations, and Cartoons).",[15],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"BEHAVIORAL","Verbal distraction technique","The Verbal distraction method technique involves:\n\npatient is given an instruction to do in order to divert his\u002Fher attention",[20],[39],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Sara Ahmed Khira, Bachelor Degree","CONTACT","00201012592478","sara.ahmed28@msa.edu.eg",[45],{"facility":46,"status":47,"city":48,"state":11,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"October University for Modern Science and Arts","RECRUITING","Giza","12451","Egypt","EG",{"type":53,"coordinates":54},"Point",[55,56],31.20861,30.00944,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":61,"phoneExt":11,"email":62},"Naglaa Ibrahim Ezz Eldin, Professor Doctor","00201001984184","niezz@msa.edu.eg",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Sara Ahmed Khira","Master degree candidate","100648166","effectiveness-of-brighthearts-biofeedback-relaxation-and-virtual-reality-distraction-during-inferior-alveolar-nerve-block-injection-in-children-100648166",false,"NCT07717229","Effectiveness of BrightHearts Biofeedback Relaxation and Virtual Reality Distraction During Inferior Alveolar Nerve Block Injection in Children","A Comparative Evaluation of the Effectiveness of the BrightHearts Application as a Biofeedback Relaxation Tool Versus Virtual Reality Distraction in Reducing Dental Anxiety and Improving Behavior in Children During Inferior Alveolar Nerve Block Injection: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Children from 7 to 12 years\n2. Children who have dental procedures that require an inferior alveolar nerve block injection.\n3. Healthy Children.\n4. Children who fall under Frankl's behavioral rating of 2 (negative) or 3 (positive)\n\nExclusion Criteria:\n\n1. Children with special health care needs\n2. Children or parents who are unable or unwilling to cooperate with the study protocol or assessment",true,"ALL","7 Years","12 Years",{"count":79,"type":80},39,"ESTIMATED","INTERVENTIONAL",[83],"NA","The study is designed to compare the effectiveness of \"BrightHearts\" biofeedback relaxation tool versus Virtual Reality distraction and Verbal distraction as a distraction methods in reducing dental anxiety and improving behavior during the inferior alveolar nerve block procedure.",[86],"Dental Anxiety",[88,89,90,91,92],"dental anxiety","inferior alveolar nerve block","brighthearts","virtual reality","biofeedback","2026-07-18",{"date":95,"type":96},"2026-07-21","ACTUAL",{"date":98,"type":96},"2025-11-15",{"date":100,"type":80},"2026-09-30",{"name":5,"class":6},1]