The Efficacy of ICU Diary on Sleep, Fatigue and Stress

NCT07631260 | Enrolling By Invitation

• 1 other identifier: REC112-21
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Keywords

ICU; family caregiver; sleep disturbance

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

interventional

EXPERIMENTAL

ICU diary and stress relaxation and sleep hygiene booklet

Other: ICU diary

Control group

NO INTERVENTION

stress relaxation and sleep hygiene booklet

Interventions

ICU diary OTHER

ICU diary

interventional

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• sleep disturbance history

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: June 8, 2026
• Study Start: November 10, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

TW (1)