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临床试验/NCT01316536
NCT01316536终止不适用

Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Decreased sedation and pain requirements

研究概览

简要总结

The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients.

详细描述

This is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated ICU patients requiring anxiolytics and analgesic medications. Patients will be randomized into two groups: one group will receive music (MUSIC), whereas the other group (CONTROL) will wear headphones, but hear an audio loop of recorded ICU sounds (vent alarms, ambient noise, talking, etc). The two groups will then be analyzed for sedation and analgesia requirements; Ramsay sedation score, ICP in brain injured patients, ventilator days, ICU length of stay, hospital length of stay, mean arterial blood pressure (MAP).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics

排除标准

  • •hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)

研究组 & 干预措施

With Music

Experimental

This randomized group will receive music

干预措施: provide headphones with music playing (Other)

Control Arm

Placebo Comparator

Will not receive music but will receive audio loop of recorded ICU sounds

干预措施: Sounds (Other)

结局指标

主要结局

Decreased sedation and pain requirements

时间窗: maximum of 7 days from study entry while still intubated and sedated

次要结局

  • ICU length of stay(from admission date to ICU to discharge date from ICU while on study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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