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临床试验/NCT04129918
NCT04129918已完成不适用

Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the Medical Intensive Care Unit Patients

Shin Kong Wu Ho-Su Memorial Hospital2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Subjective sleep quality

研究概览

简要总结

This study will investigate the effectiveness of light and sound modification in improving sleep qualit , and circadian rhythms in MICU patients with Mechanical Ventilation in Taiwan.

Hypothesis:

  1. The sleep quality in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), and Day 3 (after the third intervention).
  2. The circadian rhythm in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), Day 3 (after the third intervention).

详细描述

The subjects were divided into experimental and control groups. And the improving quality of sleep intervention was provided only in experimental group. In the experimental group,the patients used earplugs and eye masks during nighttime sleep. In the control group, the received routine intensive care.

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 (Outcomes Assessor)

盲法说明

The study was conducted on 126 patients with 56 subjects in experimental group and 56 in control group in the MICU. Effect of ear plugs & eye mask on sleep among ICU patients: a randomized control trial The participants were randomly divided into two groups: with ear plugs and eye mask (experimental group) for 3 successive nights and without ear plugs and eye mask (control group). participants were provided a Sequentially numbered opaque sealed envelopes.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU stay for 7 days
  • Endotracheal or Tracheostomy patients

排除标准

  • Patients with ear injury
  • Hearing impairment
  • Eye disease or injuries

结局指标

主要结局

Subjective sleep quality

时间窗: Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire

Subjective sleep quality

次要结局

  • Objective sleep quality(baseline, Day 1, Day 2, and Day 3] using Actigraphy)
  • Circadian rhythms(baseline, Day 1, Day 2, and Day 3] using Actigraphy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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