The Efficacy of ICU Diary on Sleep, Fatigue and Stress

June 3, 2026 updated by: Sih-hua Chen, Taichung Tzu Chi Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: interventional
Other: ICU diary
ICU diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep disturbance
Time Frame: one week
questionnaire
one week
fatigue severity
Time Frame: one week
LFS
one week
stress
Time Frame: one week
IES-R
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Tzu Chi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 8, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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