Decreasing Emergence Agitation With Personalized Music
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in Pediatric Anesthesia Emergence Delirium (PAED) scores
研究概览
简要总结
The purpose of the study is to assess the impact of personalized music on emergence agitation (EA), as measured by Pediatric Anesthesia Emergence Delirium scores in pediatric patients recovering from elective procedures under general anesthesia.
Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. The study has the potential to improve perioperative care by improving safety, decreasing the need for postoperative pharmacologic and nursing interventions, thereby shortening the time of recovery and improving caregiver satisfaction.
Participants participating in this study will be randomly assigned to receive personalized music plus standard of care, or standard of care alone. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.
详细描述
Study Protocol:
This is a prospective, randomized controlled trial of children 3-9 years of undergoing non-complex ENT procedures to assess the impact of perioperative personalized music on the incidence of emergence agitation (EA).
There will be 2 groups in the study:
- Personalized music group
- Standard care group
All patients enrolled in this study will receive a standardized anesthetic consistent with standard practice at the Stanford Children's Hospital based on their type of procedure:
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
- None
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Pediatric Anesthesia Emergence Delirium (PAED) scores
时间窗: During post operative period till the child is fully awake, usually about 45 minutes.
Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. PAED scores range from 0 to 20; a score of 10 and above is defined as emergence agitation.
次要结局
- Change in patient response to personalized music in relation to parental anxiety using State and Trait Anxiety (STAI) scores (parent-reported)(During the intra-operative period, usually about 20 minutes)
- Change in parental satisfaction with the patient's perioperative experience using a post-operative parental satisfaction survey(During the post-operative period, usually about 45 minutes)
- Change in mask acceptances using Induction Compliance Checklist (ICC)(During the intra-operative period, usually about 5 minutes)
- Change in modified Yale Preoperative Anxiety Scale (mYPAS) score(During the pre-operative period, until the child is asleep under general anesthesia, usually about 20 minutes)
- Change in post-operative pain(During the post-operative period, usually about 20 minutes)
研究者
R J Ramamurthi
Clinical Professor, Anesthesiology
Stanford University