AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

NCT07706725 | Not Yet Recruiting

• 1 other identifier: ADYU-ANS-NY-015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Adenotonsillectomy; Emergence Delirium; AI-Generated Maternal Voice; Perioperative Stress Response

Outcome Measures

Primary Outcomes (1)

• Emergence Delirium

  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.

Secondary Outcomes (5)

• Induction Compliance

  During anesthetic induction.

• Sevoflurane Consumption

  Throughout the intraoperative period.

• Mean Arterial Pressure (MAP)

  Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.

• Heart Rate (HR)

  Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.

• Heart Rate Variability (HRV)

  Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.

Study Arms (3)

AI-Generated Maternal Voice Storytelling group

EXPERIMENTAL

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.

Other: AI-Generated Maternal Voice Storytelling; Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones

Relaxing Instrumental Music group

EXPERIMENTAL

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.

Other: Relaxing Instrumental Music; Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones

Control group

ACTIVE COMPARATOR

Participants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol.

Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones

Interventions

AI-Generated Maternal Voice Storytelling OTHER

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.

AI-Generated Maternal Voice Storytelling group

Relaxing Instrumental Music OTHER

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

Relaxing Instrumental Music group

midazolam premedication DRUG

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.

AI-Generated Maternal Voice Storytelling group; Control group; Relaxing Instrumental Music group

Standard General Anesthesia Care PROCEDURE

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.

AI-Generated Maternal Voice Storytelling group; Control group; Relaxing Instrumental Music group

Headphones DEVICE

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.

AI-Generated Maternal Voice Storytelling group; Control group; Relaxing Instrumental Music group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman University

Adıyaman, 02200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

NEZİR YILMAZ, Associate Professor

CONTACT

+905068939496; yilmaznezir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind trial in which the outcome assessor will remain blinded to treatment allocation. Because of the nature of the auditory interventions, participants, caregivers, and anesthesia providers cannot be blinded. Postoperative outcome assessments, including emergence delirium and pain scores, will be performed by an independent assessor who is unaware of group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care without auditory intervention. The assigned auditory intervention will be initiated after preoperative sedation and continued throughout the perioperative period until recovery. All participants will receive the same standardized anesthetic protocol, and outcomes will be compared across the three study groups.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

TU (1)