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AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

ConditionsPediatricAdenotonsillectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAdiyaman University Research Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Generated Maternal Voice Storytelling

    Other intervention

    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.

  • Relaxing Instrumental Music

    Other intervention

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

  • 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.

  • Standard General Anesthesia Care

    Procedure/Surgery

    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.

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: AI-Generated Maternal Voice Storytelling groupExperimental treatment 4 interventions
Group B: Relaxing Instrumental Music groupExperimental treatment 4 interventions
Group C: Control groupActive comparator 3 interventions

Trial outcomes

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.

Time frame
From admission to the post-anesthesia care unit until 30 minutes after arrival.

Secondary outcomes

1

Induction Compliance

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.

Time frame
During anesthetic induction.
2

Sevoflurane Consumption

Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia.

Time frame
Throughout the intraoperative period.
3

Mean Arterial Pressure (MAP)

Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention.

Time frame
Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
4

Heart Rate (HR)

Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adiyaman University Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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