The Efficacy of ICU Diary on Sleep, Fatigue and Stress

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep
• Intervention / Treatment: Other: ICU diary

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Not in USA
    • Taichung, Not in USA, Taiwan, 427
      • Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• sleep disturbance history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional; ICU diary and stress relaxation and sleep hygiene booklet	Other: ICU diary; ICU diary
No Intervention: Control group; stress relaxation and sleep hygiene booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep disturbance	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).	baseline and one week later
fatigue severity	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).	baseline and one week later
stress	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).	baseline and one week later
Coping	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).	baseline and one week later
Social Support		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

Collaborators and Investigators

• Sponsor: Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ICU; sleep disturbance; family caregiver
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: REC112-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No