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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
240
a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained
Universidad de Barcelona
Barcelona, Spain
RECRUITINGHospital 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Time frame: 2 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Time frame: 6 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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