SleepNCT07631260
The Efficacy of ICU Diary on Sleep, Fatigue and Stress
A study testing ICU diary in people with Sleep, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- ICU diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- caregivers who has ICU patients using ventilators for more than 48 hours
Who cannot join
- sleep disturbance history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taichung, Not in USA, 427
About this study
Official title: 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.
- Conditions
- Sleep
- Being tested
- ICU diary
- Keywords
- ICU, family caregiver, sleep disturbance
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU diaryOther
ICU diary
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | ICU diary and stress relaxation and sleep hygiene booklet Receives: Other: ICU diary |
| Control group | No intervention | stress relaxation and sleep hygiene booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline and one week later
Social Support
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start10 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sih-hua Chen, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631260
- Sponsor's protocol ID
- REC112-21
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs
- ClinicalTrials.gov ID
- NCT07631260
- Acronym / sponsor ID
- REC112-21
- Conditions
- Sleep
- Keywords
- ICU, family caregiver, sleep disturbance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Other: ICU diaryICU diary and stress relaxation and sleep hygiene booklet |
| Control group | No intervention | –stress relaxation and sleep hygiene booklet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- caregivers who has ICU patients using ventilators for more than 48 hours
Key exclusion criteria (1 listed)
- sleep disturbance history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU diaryICU diary | Other | interventional |
Primary outcome
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).
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).
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).
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU diary in people with Sleep, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep disturbance (time frame: baseline and one week later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.