The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium in postanesthetic care unit (PACU)
研究概览
简要总结
The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under the age of 7 receiving a strabismus surgery under general anesthesia.
- •American Society of Anesthesiologists Physical status classification 1-2.
排除标准
- •Pediatric patients with hearing impairment or those who are currently using a hearing aid
- •Pediatric patients with neurological disorders
- •Pediatric patients with respiratory disorders
研究组 & 干预措施
Binaural beats group
Starting 30 minutes before the end of the surgery, a continuous pure tone binaural beat is delivered through headphones to the pediatric patient, with a frequency of 432 Hz in the left ear and 420 Hz in the right ear.
干预措施: Binaural beats (Other)
Silence group
The headphones are placed on the pediatric patient, but there is no sound in the audio file being played.
结局指标
主要结局
Incidence of emergence delirium in postanesthetic care unit (PACU)
时间窗: within 1hr after the end of surgery
次要结局
- Pain score (The Face, Legs, Activity, Cry and Consolability score)(within 1hr after the end of surgery)
- Paediatric Assessment of Emergence Delirium (PAED) score(within 1hr after the end of surgery (every 10 minutes, the score will be checked))
- EEG analysis during emergence period(Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery))
研究者
Jeong-Hwa Seo
professor
Seoul National University Hospital