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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05288140
Other study ID # PI-18-138
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source University of Barcelona
Contact Pilar Muñoz Rey
Phone 639534904
Email mpmunozr.germanstrias@gencat.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Spain Universidad de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary SF-36 Health Survey questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health 2 months
Primary SF-36 Health Survey questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health 6 months
Primary SF-36 Health Survey questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health 12 months
Primary 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
Primary 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
Primary 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
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