AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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.

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Emergence Delirium — 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.

Trial sites (1)

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