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Clinical Trial 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)


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04430049
Study type Observational
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase
Start date June 22, 2020
Completion date November 9, 2022

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