NCT02040051已完成不适用
Randomized Clinical Trial to Assess the Effect of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit
Althaia Xarxa Assistencial Universitària de Manresa2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Ramsay sedation scale
研究概览
简要总结
The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients of both sexes
- •Patients over 18 years old
- •Patients with a level of consciousness BIS ≥ 50
排除标准
- •Patients with withholding treatment
- •Patients with partial or complete reduction of hearing in one or both ears
- •Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc.
- •Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc.
- •Patients with an axillary temperature > 37.5º
结局指标
主要结局
Ramsay sedation scale
时间窗: Up to 4 hours
Bispectral Index (BIS)
时间窗: Up to 4 hours
Behaviour Pain Scale (BPS)
时间窗: Up to 4 hours
次要结局
- Blood pressure(Up to 4 hours)
- Respiratory frequency(Up to 4 hours)
- Endotracheal aspirations(Up to 4 hours)
- Heart rate(Up to 4 hours)
- Administration of sedatives drugs(Up to 4 hours)
- Administration of vasodilator and vasoconstrictor drugs(Up to 4 hours)
研究者
Marina Mateu-Capel
Nurse Bachelor
Althaia Xarxa Assistencial Universitària de Manresa
研究点 (2)
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