Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Richmond Agitation-Sedation Scale (RASS)
研究概览
简要总结
The objective of this study is to administer music therapy to patients in the pediatric intensive care unit (PICU) in order to observe how music affects patient agitation, vital signs, and overall recovery in the unit.
详细描述
This study is a prospective randomized controlled study to observe patients who have been admitted to the PICU with an altered state of agitation according to the Richmond Agitation Sedation Scale (RASS). These patients will be administered music therapy during a controlled setting in the day to observe whether the introduction of music therapy helps reduce the patient's level of agitation, improving their vital signs and overall recovery in the unit. Once patients are enrolled and have signed consents, patients will receive a headset with music or dead air. Therapy times will be selected so that there are minimal disruptions. Total time will be 2 hours daily, once in the morning and once in the evening. The treatments for session 1 and session 2 of the day will be the same (i.e. Music/ Music, No music/No Music).
The investigators hypothesize that applying music therapy in the PICU will decrease agitation, length of stay, and narcotic administration, and normalize heart rate, respiratory rate, and blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PICU patient at Oishei Children's Hospital of Buffalo
- •>4 years of age, <18 years of age
- •Patients with RASS of +1
排除标准
- •Documented underlying psychological disorders
- •Diagnosed with sever developmental delay
- •Prior narcotic dependence
- •Underlying medical conditions affecting heart rate, blood pressure, or neuromuscular system
- •Chemically paralyzed patients
- •Anyone with an aneurysm
- •Patients who are deaf in both ears
- •Ear bone fractures or other middle/inner ear trauma or major ear avulsion as determined by physician
- •Hemodynamically unstable patients
- •Patients facing imminent death
结局指标
主要结局
Richmond Agitation-Sedation Scale (RASS)
时间窗: 3 days
The Richmond Agitation-Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient. The scale measures patient agitation and sedation +4 to -5, with a score of 0 equal to an alert and calm patient, a positive score equal to various levels of aggression, and a negative score equal to various levels of sedation. Patients receive one score for one observed time point. Therefore, a patient will have one score from +4 to -5. For the purpose of this study, a better outcome will be a score that is around 0 or that decreases from a higher positive score to a lower positive score. The investigators hypothesize that music therapy will decrease agitation in patients and decrease their positive RASS score.
次要结局
- Bispectral Index (BIS)(3 days)
研究者
David Rothstein
Associate Professor of Surgery
State University of New York at Buffalo