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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07631260
Enrollment
142
Registered
2026-06-08
Start date
2023-11-10
Completion date
2027-12-31
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

ICU, family caregiver, sleep disturbance

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.

Interventions

ICU diary

Sponsors

Taichung Tzu Chi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* sleep disturbance history

Design outcomes

Primary

MeasureTime frameDescription
sleep disturbancebaseline and one week laterGeneral 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).
fatigue severitybaseline and one week later7-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).
stressbaseline and one week laterImpact 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).
Copingbaseline and one week laterBrief 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).
Social SupportMultidimensional 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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026