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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During anesthetic induction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NEZÄ°R YILMAZ, Associate Professor | Contact | +905068939496 | yilmaznezir@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adıyaman University | Adıyaman | 02200 | Turkey (Türkiye) |
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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.
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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.
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| Relaxing Instrumental Music | Other | Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery. |
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| 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. |
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| 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. |
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| 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. |
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| Sevoflurane Consumption | Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia. | Throughout the intraoperative period. |
| 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. | Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction. |
| Heart Rate (HR) | Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention. | Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction. |
| Heart Rate Variability (HRV) | 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. | Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction. |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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