Efficacy of the intensive care unit diary: a mixed-method study protocol.
Pilar Muñoz-Rey, Marta Romero-García, Isabel Anglès-Sabatè...
https://pubmed.ncbi.nlm.nih.gov/41555387Actively Recruiting
Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID05288140
Efficacy of the Use of Diaries in Intensive Care Units
Led by University of Barcelona · Updated on 2024-03-27
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
This clinical trial evaluates the effect of using a diary for patients admitted to the intensive care unit (ICU) and their relatives. It compares the usual ICU practice, where patient progress is verbally reported to families, against an experimental approach where a diary is kept explaining events during sedation and intubation. The study aims to assess impacts on health-related quality of life, post-traumatic stress, anxiety, and depression at 2, 6, and 12 months after ICU discharge. Participants are randomly assigned to one of two groups: the control group receiving usual care and the experimental group receiving a diary during their ICU stay. The diary records important events and experiences over the sedation and mechanical ventilation period. The study is open and non-blinded, conducted across multiple centers, with about 120 participants in each group. A preliminary pilot test is also included. Throughout the study, researchers will measure outcomes using three validated scales: the Hospital Anxiety and Depression Scale (HADS), the SF-36 Health Survey, and the Revised Impact of Event Scales (IES-R) at 2, 6, and 12 months post-ICU. Participants and their relatives will attend follow-up visits for these assessments. Data will be analyzed to compare quality of life and mental health outcomes between groups, with the total study duration extending up to one year after ICU discharge.
CONDITIONS
Brief Title
Efficacy of the Use of Diaries in Intensive Care Units
Who Can Participate
Age: 18Years - 100Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Admitted to an intensive care unit
- Sedated and mechanically ventilated for at least 24 hours
- Signed consent to participate
- No language barriers that prevent communication
- Willingness to attend follow-up visits after ICU discharge
You will not qualify if you...
- Verbal history of psychiatric, mental, or cognitive disorders
- Individuals who do not voluntarily agree to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
ICU Stay with Diary or Usual Practice
Duration - Duration of ICU stay
Participants are either provided with a diary explaining events during sedation and intubation or receive usual verbal reporting to family members during their ICU stay.
Follow-up Assessments
Duration - 12 months
Participants complete assessments of anxiety, depression, post-traumatic stress, and quality of life at multiple time points after ICU discharge.
Visits at 2 months, 6 months, and 12 months post-ICU discharge
Trial Site Locations
Total: 1 location
1
Universidad de Barcelona
Barcelona, Spain, 08185
Actively Recruiting
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Research Team
P
Pilar Muñoz Rey
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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