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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04441476
Recruitment Status : Active, not recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
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.

Condition or disease Intervention/treatment
Psychological Strain Other: Questionnaires Other: psychological and sociological interviews

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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
ICU staff Other: Questionnaires

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.

Other: psychological and sociological interviews

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
nursing staff in French hospitals

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04441476

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Chu Dijon Bourgogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT04441476    
Other Study ID Numbers: QUENOT SERI 2020
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries