Ethical and Psychological Support for Health Care Professions in Intensive Care Units in the COVID19 Pandemic Context: Adequacy With Needs and Psychological Impact Crisis and Post-crisis (PsyCOVID)

March 29, 2021 updated by: Centre Hospitalier Universitaire Dijon
The intensive care unit occupies a particular place in our health care system. The urgency of the clinical situations, the proportion of deaths encountered, and the daily workload is likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is unprecedented and has leads to the unprecedented mobilisation of care providers, particularly in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and material resources are overwhelmed and the teams are faced with an unusually heavy workload in a context of extreme tension. These professionals are thus exposed to a risk of over-investment, in a context of acute and repetitive stress, over an indeterminate period of time combining workload, emotional intensity with specific ethical issues, simultaneously affecting the professional sphere but also the personal and family sphere (confinement, risk of contamination). Now more than ever, the mental health of caregivers is an important concern, as highlighted by the CCNE. Mental health is understood in the way in which the individual responds specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the issue of mental health in the ICU cannot be considered without taking into account the strategies that professionals put in place to combat stress and to contribute or not to the construction and stabilization of the work collective (collaboration, support). Ethical and/or psychological support systems have been set up in most of the establishments involved in the care of Covid-19 patients. However, the adequacy of these systems relative to the needs of professionals during and after the crisis is not yet known. We hypothesize that the psychological and social repercussions of this pandemic as well as the individual and collective strategies deployed by ICU care providers to deal with it will evolve in view of the progression of the crisis but also of the various types of support, particularly psychological and/or ethical, available to them.

Study Overview

Study Type

Observational

Enrollment (Actual)

3080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dijon, France, 21000
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

nursing staff in French hospitals

Description

Inclusion Criteria:

  • The study population is the entire ICU staff of the participating centres, whether they are permanently or transiently assigned to these units and/or the institution, whether they are students or not.

Professionals involved in psychological and ethical support structures may also be interviewed to provide the information necessary to describe and evaluate the organisations and their evolution.

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU staff

An online questionnaire (Limesurvey platform) will be made available at 4 different times (M0, M1, M2 and M6).

  • The first questionnaires (M0 and M1) will include a component for professional characterization. Generic and specific stress factors related to ICU and the current pandemic and collective and individual defensive strategies will also be collected in M0 and M1.
  • At M2 and M6, the traumatic impact of the crisis, burnout, signs of depression and recourse to internal or external support in the department (occupational medicine, support unit) will be collected.

conducting semi-directive psychological interviews (40 interviews in M2, 40 interviews in M6).

sociological interviews: 40 (20 in M1-M2 then 20 in M6) in order to understand the consequences of the epidemic on daily life, both intra-family and micro-social.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PS-ICU Scale Score
Time Frame: Through study completion, an average of 6 months after the epidemic peak
This scale integrates generic stressors as well as factors specific to intensive care and crises.
Through study completion, an average of 6 months after the epidemic peak

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 21, 2020

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ACTUAL)

December 21, 2020

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (ACTUAL)

June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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