NCT05288140

Efficacy of the Use of Diaries in Intensive Care Units

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diary (Blank Journal)
• Intensive Care Unit
• Patient
• Family
• PICS
• Stress
• Anxiety
• Depression
• Quality of Life

Interventions

Type	Name	Description
OTHER	use of diary	a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-03-21
• Last updated: 2024-03-27

Locations

1 site across 1 country: Spain