[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651491":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Audiovisual Distraction Group","EXPERIMENTAL","Pediatric patients receive non-wearable immersive audiovisual distraction via a mobile display (LG StanbyME presenting low-stimulation, guided soothing videos and simple interactive games) during emergency department procedures.",[13],"Behavioral: Non-Wearable Audiovisual Distraction",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Care Group","ACTIVE_COMPARATOR","Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices.",[19],"Other: Routine ED Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Non-Wearable Audiovisual Distraction","Implementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Routine ED Care","Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.",[15],[32],{"name":33,"affiliation":5,"role":34},"Nai-Yun Chang, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+886-972-655-205","gigi06060606@gmail.com",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"National Taiwan University Hospital Yunlin Branch","Douliu","Yunlin County","640203","Taiwan","TW",{"type":49,"coordinates":50},"Point",[51,52],120.54333,23.70944,{"lat":52,"lon":51},[55],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[59],{"name":60,"class":61},"National Yunlin University of Science and Technology","UNKNOWN","100651491","non-wearable-audiovisual-distraction-for-childrens-medical-anxiety-in-the-ed-100651491",false,"NCT07761637","Non-Wearable Audiovisual Distraction for Children's Medical Anxiety in the ED","Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial","Inclusion Criteria:\n\n* Pediatric patients aged 6 to 12 years presenting to the Emergency Department.\n* Requiring invasive medical procedures (e.g., blood sampling, intravenous line insertion, or laceration repair\u002Fsuturing).\n* Patient and legal guardian\u002Fparent willing and able to provide informed assent\u002Fconsent and comply with study protocols.\n\nExclusion Criteria:\n\n* Patients with severe developmental delay, cognitive impairment, or neurological disorders affecting communication or behavioral assessment.\n* Patients with severe visual or hearing impairment that prevents interaction with the non-wearable display system.\n* Hemodynamically unstable patients or those requiring immediate life-saving resuscitation.\n* Patients with severe upper body or facial injuries that prevent the placement or operation of continuous ECG recorders.","ALL","6 Years","12 Years",{"count":73,"type":74},90,"ESTIMATED","INTERVENTIONAL",[77],"NA","Pediatric emergency department (ED) visits often cause significant anxiety and stress for young patients due to unfamiliar environments and invasive medical procedures. Non-pharmacological interventions, such as distraction, are vital for reducing pediatric anxiety and improving procedural outcomes.\n\nThis study evaluates the effectiveness of a non-wearable, immersive audiovisual distraction system (LG StanbyME display) in alleviating pediatric anxiety during emergency department care, compared to standard care.\n\nThe main questions it aims to answer are:\n\nDoes non-wearable audiovisual distraction reduce anxiety levels in pediatric emergency patients compared to standard care?\n\nDoes the intervention improve physiological indicators of distress, such as Heart Rate Variability (HRV)?\n\nParticipants will:\n\nBe randomly assigned to either the non-wearable audiovisual distraction group or the routine care group.\n\nUndergo continuous physiological monitoring (HRV) and clinical anxiety assessment (mYPAS-SF) during their ED visit.",[80],"Pediatric Anxiety",[82,83,84,85,86,87],"Audiovisual Distraction","Pediatric Emergency Medicine","Heart Rate Variability","Non-Wearable Technology","mYPAS-SF","Procedural Pain and Anxiety","NOT_YET_RECRUITING","2026-08-09",{"date":91,"type":92},"2026-08-12","ACTUAL",{"date":94,"type":74},"2026-09-01",{"date":96,"type":74},"2027-09-30",{"name":5,"class":6},1]