Impact of Using Diaries During ICU Stay on Quality of Life and Mental Health in Patients and Their Families

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.

Efficacy of the Use of Diaries in Intensive Care Units