Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
- Conditions
- Covid-19Critical IllnessFamily Members
- Registration Number
- NCT04430049
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)
- Detailed Description
Observational multicenter study
Three groups are compared:
* no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
* restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
* open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are
* to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
* to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups
* to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
* to identify the factor associated with significant symptoms of both anxiety and depression
* to identify the factor associated with significant PTSD-related symptoms
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 811
- Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.
- Relative who declines the enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety Between 3 and 6 months Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.Depression Between 3 and 6 months Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.
- Secondary Outcome Measures
Name Time Method post-traumatic stress disorder between 3 and 6 months Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient.
IES-R ranges from 0 to 88; higher scores indicate worse symptoms
Trial Locations
- Locations (11)
University hospital, Clermont-Ferrand
🇫🇷Clermont-Ferrand, Auvergne, France
CH Aurillac
🇫🇷Aurillac, France
CH Cannes
🇫🇷Cannes, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CH Grenoble
🇫🇷Grenoble, France
CH Le Puy-en-Velay
🇫🇷Le Puy-en-Velay, France
University hopistal, Lyon
🇫🇷Lyon, France
CH Moulins
🇫🇷Moulins, France
CH Périgueux
🇫🇷Périgueux, France
CH Rodez
🇫🇷Rodez, France
Scroll for more (1 remaining)University hospital, Clermont-Ferrand🇫🇷Clermont-Ferrand, Auvergne, France