Anxiety, Depression, Diary (Blank Journal), Family, Intensive Care Unit, Patient, PICS, Quality of Life, Stress
Conditions
Brief 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.
Interventions
OTHERuse of diary
a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A control group and an experimental group
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | 2 months | 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. |
| SF-36 Health Survey | 2 months | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health |
| Revised Impact of Event Scales (IES-R) | 2 months | 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. |
Countries
Spain
Contacts
Primary ContactPilar Muñoz Rey
Outcome results
None listed