Efficacy of the Use of Diaries in Intensive Care Units

Not Applicable

Recruiting

• Conditions: Anxiety; Patient; Intensive Care Unit; PICS; Quality of Life; Family; Stress; Diary (Blank Journal); Depression
• Interventions: Other: use of diary

• Registration Number: NCT05288140
• Lead Sponsor: University of Barcelona

Brief Summary

Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.

Detailed Description

Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• admitted intensive care unit
• sedated and mechanically ventilated for 24hours
• signed consent
• not language barrier
• willingness to attend follow-up visits

Exclusion Criteria

• verbal manifestation of psychiatric, mental or cognitive antecedents
• who do not coluntarily agree to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICU diary	use of diary	Made a diary

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	12 months	questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin.
SF-36 Health Survey	12 months	questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Revised Impact of Event Scales (IES-R)	12 months	questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.

Trial Locations

Locations (1)

Universidad de Barcelona; 🇪🇸 Barcelona, Spain