AI-Generated Maternal Voice Storytelling Modulates the Perioperative Stress Response and Reduces Emergence Delirium in Children Undergoing Adenotonsillectomy: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Emergence Delirium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Emergence Delirium
时间窗: 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.
次要结局
- Induction Compliance(During anesthetic induction.)
- Sevoflurane Consumption(Throughout the intraoperative period.)
- Mean Arterial Pressure (MAP)(Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.)
- Heart Rate (HR)(Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.)
- Heart Rate Variability (HRV)(Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.)
研究者
Nezir Yılmaz
Associate Professor
Adiyaman University Research Hospital