AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
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
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
Treatments tested in this trial
- AI-Generated Maternal Voice Storytelling
- Relaxing Instrumental Music
- midazolam premedication
- Standard General Anesthesia Care
- Headphones
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov