Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Variation of respiratory discomfort during the 30 first minutes of NIV
研究概览
简要总结
Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.
详细描述
We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit protocol; "sensory isolation" assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •respiratory distress requiring NIV
- •Glasgow coma score above 12
排除标准
- •NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting
- •Severe hypoacusis people without hearing device
- •Decision to limit active treatment with an estimated life expectancy of less than 48 hours
研究组 & 干预措施
Musical intervention and sensory isolation
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
干预措施: Musical intervention and sensory isolation (Behavioral)
Sensory isolation
Sensory isolation
干预措施: Musical intervention and sensory isolation (Behavioral)
Standard of care
Standard of care
结局指标
主要结局
Variation of respiratory discomfort during the 30 first minutes of NIV
时间窗: 30 minutes
Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.
次要结局
- Quality of life(3 months)
- Post traumatic stress disorder(3 months)
- Number of NIV failure(participants will be followed for the duration of hospital stay or maximum 28 days)
- overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)(3 months)
- Evolution of respiratory parameters(participants will be followed for the duration of hospital stay or maximum 28 days)
- Evolution of cardiovascular parameters(participants will be followed for the duration of hospital stay or maximum 28 days)