AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
2026年7月10日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：NEZİR YILMAZ, Associate Professor
- 電話番号：+905068939496
- メール：yilmaznezir@hotmail.com
研究場所
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Adıyaman、トルコ（Türkiye）、02200
- Adıyaman University
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コンタクト：
- Nezir Yılmaz
- 電話番号：05068939496
- メール：yilmaznezir@hotmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Emergence Delirium
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Induction Compliance
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月20日
一次修了 (推定)
2026年9月20日
研究の完了 (推定)
2026年9月20日
試験登録日
最初に提出
2026年7月6日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ADYU-ANS-NY-015
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