White Noise to Improve Sleep in the MICU: a Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Intervention fidelity: percent of intervention time during which white noise is actually delivered
研究概览
简要总结
A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.
详细描述
The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18yo admitted to MICU with expected stay of at least two nights after enrollment
排除标准
- •Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
- •Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded
结局指标
主要结局
Intervention fidelity: percent of intervention time during which white noise is actually delivered
时间窗: 48 hours
percent of intervention time during which white noise is actually delivered
次要结局
- Sound Levels(48 hours)
- Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.(48 hours)
- Actigraphic rest-activity :Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.(48 hours)
- Patient acceptance: percent of patients or surrogates who agree to receive white noise at night(48 hours)
- Patient tolerance: percent of days that patients agree to continue white noise(48 hours)