NCT04430049

Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients

Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 811 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Covid-19
• Family Members
• Critical Illness

Interventions

Type	Name	Description
PROCEDURE	Covid ICU containment measures	The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

Timeline

• Start date: 2020-06-22
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2020-06-12
• Last updated: 2023-02-08

Locations

11 sites across 1 country: France