Efficacy of the Use of Diaries in Intensive Care Units
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: use of diary.
- Who it may be relevant to
- Registry conditions: Diary (Blank Journal), Intensive Care Unit, Patient, Family. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 2 months]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 6 months]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 12 months]
- SF-36 Health Survey [Time frame: 2 months]
- SF-36 Health Survey [Time frame: 6 months]
- SF-36 Health Survey [Time frame: 12 months]
- Revised Impact of Event Scales (IES-R) [Time frame: 2 months]
- Revised Impact of Event Scales (IES-R) [Time frame: 6 months]
- Revised Impact of Event Scales (IES-R) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Universidad de Barcelona — Barcelona
Publications
- Munoz-Rey P, Romero-Garcia M, Angles-Sabate I, Ausio-Dot A, Alonso-Fernandez S, Alcala-Jimenez I, Huertas-Zurriaga A, Tur-Rubio C, Delgado-Hito P. Efficacy of the intensive care unit diary: a mixed-method study protocol. BMC Nurs. 2026 Jan 19;25(1):153. doi: 10.1186/s12912-026-04300-z. PMID 41555387
Identifiers
NCT: NCT05288140 · PI-18-138