Efficacy of the Use of Diaries in Intensive Care Units

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of the Use of Diaries in Intensive Care Units

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

Intervention / Treatment
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* Other: use of diary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A control group and an experimental group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual ICU practice<br>The patient's evolution is reported verbally to the family. | |
| Experimental: ICU diary<br>Made a diary | Other: use of diary<br>* a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | 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. | 2 months | 
| Hospital Anxiety and Depression Scale (HADS) | 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. | 6 months | 
| Hospital Anxiety and Depression Scale (HADS) | 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. | 12 months | 
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 2 months | 
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 6 months | 
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 12 months | 
| Revised Impact of Event Scales (IES-R) | 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. | 2 months | 
| Revised Impact of Event Scales (IES-R) | 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. | 6 months | 
| Revised Impact of Event Scales (IES-R) | 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. | 12 months |