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AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

10. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Arzneimittel: 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.
Verfahren: 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/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.
Gerät: 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.
Experimental: 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.
Arzneimittel: 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.
Verfahren: 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/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.
Gerät: 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.
Sonstiges: Relaxing Instrumental Music
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
Aktiver Komparator: Control group
Participants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol.
Arzneimittel: 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.
Verfahren: 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/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Emergence Delirium
Zeitfenster: From admission to the post-anesthesia care unit until 30 minutes after arrival.
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.
From admission to the post-anesthesia care unit until 30 minutes after arrival.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Induction Compliance
Zeitfenster: During anesthetic induction.
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.
During anesthetic induction.
Sevoflurane Consumption
Zeitfenster: Throughout the intraoperative period.
Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia.
Throughout the intraoperative period.
Mean Arterial Pressure (MAP)
Zeitfenster: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention.
Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate (HR)
Zeitfenster: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention.
Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate Variability (HRV)
Zeitfenster: Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
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.
Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Adiyaman University Research Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juli 2026

Primärer Abschluss (Geschätzt)

20. September 2026

Studienabschluss (Geschätzt)

20. September 2026

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ADYU-ANS-NY-015

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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