AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
2026년 7월 10일 업데이트: Nezir Yılmaz, Adiyaman University Research Hospital
AI-Generated Maternal Voice Storytelling Modulates the Perioperative Stress Response and Reduces Emergence Delirium in Children Undergoing Adenotonsillectomy: A Three-Arm Randomized Controlled Trial
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
Pediatric adenotonsillectomy is frequently associated with perioperative anxiety, autonomic stress responses, and emergence delirium despite standardized anesthetic management. Non-pharmacological auditory interventions, including music and maternal voice exposure, have been investigated as potential strategies to improve perioperative outcomes. However, the effects of personalized artificial intelligence (AI)-generated maternal voice storytelling have not been evaluated in pediatric surgical patients.
This prospective, single-center, three-arm randomized controlled trial will investigate the effects of AI-generated maternal voice storytelling on perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy under general anesthesia. Participants will be randomly assigned to one of three groups: (1) AI-generated maternal voice storytelling, (2) relaxing instrumental music, or (3) standard care without auditory intervention.
The assigned auditory intervention will be initiated after premedication and continued throughout the perioperative period using headphones. Standardized anesthesia protocols will be applied to all participants. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes will include induction compliance, perioperative hemodynamic variables, sevoflurane consumption, postoperative pain scores, and recovery characteristics. The study aims to determine whether personalized AI-generated maternal voice storytelling influences perioperative outcomes compared with relaxing music and standard perioperative care.
연구 유형
중재적
등록 (추정된)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: NEZİR YILMAZ, Associate Professor
- 전화번호: +905068939496
- 이메일: yilmaznezir@hotmail.com
연구 장소
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Adıyaman, 터키 (Türkiye), 02200
- Adıyaman University
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연락하다:
- Nezir Yılmaz
- 전화번호: 05068939496
- 이메일: yilmaznezir@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Children aged 3 to 12 years.
- Scheduled for elective adenotonsillectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
- Hearing impairment or inability to receive auditory stimulation.
- Developmental delay, neurological or psychiatric disorders.
- Use of sedative, antipsychotic, or anticonvulsant medications.
- Known allergy or contraindication to study medications.
- Refusal of participation by the parent/legal guardian.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AI-Generated Maternal Voice Storytelling group
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.
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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.
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.
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/air mixture throughout the surgical procedure.
Intraoperative monitoring and anesthetic management are standardized for all study groups.
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.
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실험적: 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.
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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.
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/air mixture throughout the surgical procedure.
Intraoperative monitoring and anesthetic management are standardized for all study groups.
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.
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
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활성 비교기: Control group
Participants will receive standard perioperative care without headphones or auditory intervention.
Standardized general anesthesia will be administered according to the study protocol.
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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.
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/air mixture throughout the surgical procedure.
Intraoperative monitoring and anesthetic management are standardized for all study groups.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emergence Delirium
기간: From admission to the post-anesthesia care unit until 30 minutes after arrival.
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Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) Scale.
The PAED Scale consists of five items, with total scores ranging from 0 to 20.
Higher scores indicate more severe emergence delirium, whereas lower scores indicate less or no emergence delirium.
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From admission to the post-anesthesia care unit until 30 minutes after arrival.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Induction Compliance
기간: During anesthetic induction.
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Induction compliance will be assessed using the Induction Compliance Checklist (ICC).
The ICC consists of 10 behavioral items, with total scores ranging from 0 to 10. Lower scores indicate better compliance with anesthesia induction, whereas higher scores indicate poorer compliance and greater distress during induction.
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During anesthetic induction.
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Sevoflurane Consumption
기간: Throughout the intraoperative period.
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Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia.
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Throughout the intraoperative period.
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Mean Arterial Pressure (MAP)
기간: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
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Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention.
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Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
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Heart Rate (HR)
기간: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
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Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention.
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Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
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Heart Rate Variability (HRV)
기간: Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
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Heart rate variability (HRV) parameters, including time-domain (e.g., SDNN and RMSSD) and frequency-domain (e.g., LF, HF, and LF/HF ratio) indices, will be analyzed to assess autonomic nervous system activity and perioperative stress responses associated with the assigned intervention.
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Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 20일
기본 완료 (추정된)
2026년 9월 20일
연구 완료 (추정된)
2026년 9월 20일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ADYU-ANS-NY-015
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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