Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
NCT ID: NCT04430049
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
811 participants
OBSERVATIONAL
2020-06-22
2022-11-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit
NCT04872049
Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder
NCT03846323
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
NCT04747405
Improving FAMily Members' Experience in the ICU
NCT05461521
Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers
NCT04341519
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
no visitation group
relatives cannot visit ICU patient during Covid pandemic period in France
Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
restrictive visitation group
relatives have restriction to visit ICU patient during Covid pandemic period in France
Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
open visitation group
relatives can visit ICU patient during no Covid period in France
Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Covid ICU containment measures
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
CH Vichy
Vichy, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020 HAD-Covid
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.