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AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

NCT07706725 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric
  • Adenotonsillectomy

Interventions

OTHER

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.

OTHER

Relaxing Instrumental Music

Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.

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.

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/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.

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.

Sponsors & Collaborators

  • Adiyaman University Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2026-09-20
Completion
2026-09-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706725 on ClinicalTrials.gov