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Enrolling by Invitation

NCT Number: NCT07631260

The Efficacy of ICU Diary on Sleep, Fatigue and Stress

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • caregivers who has ICU patients using ventilators for more than 48 hours

Exclusion criteria

  • sleep disturbance history

Treatment and study plan

ICU diary

Other

ICU diary

Primary outcomes

  1. sleep disturbance

    Time frame: baseline and one week later

    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).

  2. fatigue severity

    Time frame: baseline and one week later

    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).

  3. stress

    Time frame: 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).

  4. Coping

    Time frame: baseline and one week later

    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).

  5. Social Support

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taichung Tzu Chi Hospital

Other

Registry information

Official study title

The Effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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