The Efficacy of ICU Diary on Sleep, Fatigue and Stress
2026年6月21日 更新者：Sih-hua Chen、Taichung Tzu Chi Hospital
The Effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs
To create a constructive ICU diary and to comprehend the effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs.
研究概览
研究类型
介入性
注册 (估计的)
142
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Not in USA
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Taichung、Not in USA、台湾、427
- Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- caregivers who has ICU patients using ventilators for more than 48 hours
Exclusion Criteria:
- sleep disturbance history
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：interventional
ICU diary and stress relaxation and sleep hygiene booklet
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ICU diary
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无干预：Control group
stress relaxation and sleep hygiene booklet
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
sleep disturbance
大体时间：baseline and one week later
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General Sleep disturbances Scale (GSDS) GSDS was used to measure sleep disturbances (Lee, 2007).
The GSDS is a 21-item self-report instrument that assesses sleep patterns during the previous week across seven domains: difficulty initiating sleep, mid-sleep awakenings, early awakenings, sleep quality, sleep quantity, daytime sleepiness, and use of substances to aid sleep (Lee, 1992).
Items are rated on an 8-point Likert scale ranging from 0 (never) to 7 (every day).
A mean item or subscale score ≥ 3 indicates sleep disturbances (Lee, 1992).
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baseline and one week later
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fatigue severity
大体时间：baseline and one week later
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7-item Lee's Fatigue Scale (LFS) Fatigue was assessed using the 7-item Lee Fatigue Scale (LFS) (Lee et al., 1991; Tsai et al., 2014).
Items are rated from 0 (not at all) to 10 (extremely), with higher scores indicating greater fatigue severity.
A mean score > 3.3 indicates clinically significant fatigue (Lee et al., 1991).
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baseline and one week later
|
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stress
大体时间：baseline and one week later
|
Impact of Event Scale-Revised (IES-R) Perceived stress was assessed using IES-R, which consists of 22 items across three subscales, including intrusion, avoidance, and hyperarousal symptoms related to a traumatic event (Weiss & Marmar, 1997; Wu & Chan, 2003).
Total scores range from 0 to 88, with higher scores indicating greater distress.
A total score ≥ 33 or a mean item score ≥ 1.5 has been suggested as indicative of a higher risk of PTSD (Creamer et al., 2003).
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baseline and one week later
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Coping
大体时间：baseline and one week later
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Brief Coping Orientation to Problems Experienced (Brief COPE) The Brief COPE was used to measure coping strategies, which is a 28-item self-report instrument designed to assess coping responses to stress (Carver, 1997; Su et al., 2015).
Items are rated on a 4-point Likert scale ranging from 1 (I have not been doing this at all) to 4 (I have been doing this a lot), with higher scores indicating more frequent use of a coping strategy.
Brief COPE scores were categorized into three dimensions, including active coping, dysfunctional coping, and distraction coping, based on a factor structure validated among Taiwanese caregivers of children with chronic illness (Tang et al., 2021).
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baseline and one week later
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Social Support
大体时间：Multidimensional Scale of Perceived Social Support (MSPSS) The MSPSS is a 12-item self-report instrument that assesses perceived support from three sources: family, friends, and significant others, with four items in each subscale (Chou, 2000; Zimet et
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Multidimensional Scale of Perceived Social Support (MSPSS) The MSPSS is a 12-item self-report instrument that assesses perceived support from three sources: family, friends, and significant others, with four items in each subscale (Chou, 2000; Zimet et
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月10日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2024年11月26日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月24日
上次提交的符合 QC 标准的更新
2026年6月21日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.