[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647391":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":32,"centralContacts":52,"locations":58,"responsibleParty":74,"collaborators":32,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":32,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":32,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":102,"whyStopped":32,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Adiyaman University Research Hospital","OTHER",[8,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Generated Maternal Voice Storytelling group","EXPERIMENTAL","Participants will receive personalized AI-generated maternal voice storytelling through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. The audio will be created from a pre-recorded maternal voice sample using artificial intelligence voice synthesis. Standardized general anesthesia will be administered.",[13,14,15,16],"Other: AI-Generated Maternal Voice Storytelling","Drug: midazolam premedication","Procedure: Standard General Anesthesia Care","Device: Headphones",{"label":18,"type":10,"description":19,"interventionNames":20},"Relaxing Instrumental Music group","Participants will receive relaxing instrumental music through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. Standardized general anesthesia will be administered.",[21,14,15,16],"Other: Relaxing Instrumental Music",{"label":23,"type":24,"description":25,"interventionNames":26},"Control group","ACTIVE_COMPARATOR","Participants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol.",[14,15,16],[28,33,37,42,47],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"AI-Generated Maternal Voice Storytelling","Personalized storytelling generated using artificial intelligence voice synthesis based on a pre-recorded maternal voice sample. The audio intervention will be delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.",[9],null,{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Relaxing Instrumental Music","Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.",[18],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"DRUG","midazolam premedication","All participants receive intravenous midazolam as standard premedication before anesthesia induction according to the institutional pediatric anesthesia protocol to reduce preoperative anxiety and facilitate smooth separation from parents.",[9,23,18],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":32},"PROCEDURE","Standard General Anesthesia Care","All participants receive standardized general anesthesia according to the institutional pediatric anesthesia protocol. Anesthesia is induced with intravenous propofol, fentanyl, and rocuronium, followed by endotracheal intubation. Anesthesia is maintained with sevoflurane in an oxygen\u002Fair mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.",[9,23,18],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":32},"DEVICE","Headphones","Over-ear headphones are used in all study groups during the perioperative period. In the AI-generated maternal voice storytelling and relaxing music groups, the headphones deliver the assigned auditory intervention. In the control group, headphones are worn without audio playback to minimize exposure to environmental noise and to maintain consistency across study groups.",[9,23,18],[53],{"name":54,"role":55,"phone":56,"phoneExt":32,"email":57},"NEZİR YILMAZ, Associate Professor","CONTACT","+905068939496","yilmaznezir@hotmail.com",[59],{"facility":60,"status":32,"city":61,"state":32,"zip":62,"country":63,"countryCode":32,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Adıyaman University","Adıyaman","02200","Turkey (Türkiye)",{"type":65,"coordinates":66},"Point",[67,68],38.27629,37.76441,{"lat":68,"lon":67},[71],{"name":72,"role":55,"phone":73,"phoneExt":32,"email":57},"Nezir Yılmaz","05068939496",{"type":75,"investigatorFullName":72,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Associate Professor","100647391","ai-generated-maternal-voice-storytelling-during-pediatric-adenotonsillectomy-100647391",false,"NCT07706725","AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy","AI-Generated Maternal Voice Storytelling Modulates the Perioperative Stress Response and Reduces Emergence Delirium in Children Undergoing Adenotonsillectomy: A Three-Arm Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 3 to 12 years.\n* Scheduled for elective adenotonsillectomy under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Hearing impairment or inability to receive auditory stimulation.\n* Developmental delay, neurological or psychiatric disorders.\n* Use of sedative, antipsychotic, or anticonvulsant medications.\n* Known allergy or contraindication to study medications.\n* Refusal of participation by the parent\u002Flegal guardian.","ALL","3 Years","12 Years",{"count":88,"type":89},90,"ESTIMATED","INTERVENTIONAL",[92],"NA","This prospective, three-arm randomized controlled trial aims to evaluate the effects of AI-generated maternal voice storytelling on the perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy. Participants will be randomly assigned to receive AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care. Standardized anesthesia protocols will be used in all groups, and perioperative outcomes will be compared among the three study arms.",[95,96],"Pediatric","Adenotonsillectomy",[98,99,100,101],"Pediatric Adenotonsillectomy","Emergence Delirium","AI-Generated Maternal Voice","Perioperative Stress Response","NOT_YET_RECRUITING","2026-07-10",{"date":105,"type":106},"2026-07-16","ACTUAL",{"date":108,"type":89},"2026-07-20",{"date":110,"type":89},"2026-09-20",{"name":5,"class":6},1]