AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
10. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
90
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: NEZİR YILMAZ, Associate Professor
- Telefonní číslo: +905068939496
- E-mail: yilmaznezir@hotmail.com
Studijní místa
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Adıyaman, Turecko (Türkiye), 02200
- Adıyaman University
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Kontakt:
- Nezir Yılmaz
- Telefonní číslo: 05068939496
- E-mail: yilmaznezir@hotmail.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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.
|
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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Aktivní komparátor: Control group
Participants will receive standard perioperative care without headphones or auditory intervention.
Standardized general anesthesia will be administered according to the study protocol.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Emergence Delirium
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Induction Compliance
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
20. července 2026
Primární dokončení (Odhadovaný)
20. září 2026
Dokončení studie (Odhadovaný)
20. září 2026
Termíny zápisu do studia
První předloženo
6. července 2026
První předloženo, které splnilo kritéria kontroly kvality
10. července 2026
První zveřejněno (Aktuální)
16. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ADYU-ANS-NY-015
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