Adenotonsillectomy, Pediatric
Conditions
Keywords
Pediatric Adenotonsillectomy, Emergence Delirium, AI-Generated Maternal Voice, Perioperative Stress Response
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.
Detailed description
Pediatric adenotonsillectomy is frequently associated with perioperative anxiety, autonomic stress responses, and emergence delirium despite standardized anesthetic management. Non-pharmacological auditory interventions, including music and maternal voice exposure, have been investigated as potential strategies to improve perioperative outcomes. However, the effects of personalized artificial intelligence (AI)-generated maternal voice storytelling have not been evaluated in pediatric surgical patients. This prospective, single-center, three-arm randomized controlled trial will investigate the effects of AI-generated maternal voice storytelling on perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy under general anesthesia. Participants will be randomly assigned to one of three groups: (1) AI-generated maternal voice storytelling, (2) relaxing instrumental music, or (3) standard care without auditory intervention. The assigned auditory intervention will be initiated after premedication and continued throughout the perioperative period using headphones. Standardized anesthesia protocols will be applied to all participants. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes will include induction compliance, perioperative hemodynamic variables, sevoflurane consumption, postoperative pain scores, and recovery characteristics. The study aims to determine whether personalized AI-generated maternal voice storytelling influences perioperative outcomes compared with relaxing music and standard perioperative care.
Interventions
OTHERAI-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.
OTHERRelaxing Instrumental Music
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
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.
PROCEDUREStandard 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.
DEVICEHeadphones
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
Adiyaman University Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Induction Compliance | During anesthetic induction. | 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. |
| Sevoflurane Consumption | Throughout the intraoperative period. | Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia. |
| Mean Arterial Pressure (MAP) | Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction. | Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention. |
| Heart Rate (HR) | Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction. | Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention. |
| Heart Rate Variability (HRV) | Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction. | Heart rate variability (HRV) parameters, including time-domain (e.g., SDNN and RMSSD) and frequency-domain (e.g., LF, HF, and LF/HF ratio) indices, will be analyzed to assess autonomic nervous system activity and perioperative stress responses associated with the assigned intervention. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNEZİR YILMAZ, Associate Professor
Outcome results
None listed