Psychological StrainPsyCOVIDNCT04441476
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
An observational study of Psychological Strain, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Strain
- What is being tested?
- Questionnaires and psychological and sociological interviews
- How many people
- 3,080 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2020to 21 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: nursing staff in French hospitals
Who may be able to join
- 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.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Psychological Strain
- Being tested
- Questionnaires, psychological and sociological interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
psychological and sociological interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICU staff | Not described Receives: Other: Questionnaires; Other: psychological and sociological interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
PS-ICU Scale Score
This scale integrates generic stressors as well as factors specific to intensive care and crises.
Measured: Through study completion, an average of 6 months after the epidemic peak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start21 Apr 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StrainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441476
- Sponsor's protocol ID
- QUENOT SERI 2020
- Acronym
- PsyCOVID
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04441476
- Acronym / sponsor ID
- PsyCOVID / QUENOT SERI 2020
- Conditions
- Psychological Strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,080 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU staff | – | Other: Questionnaires, Other: psychological and sociological interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- nursing staff in French hospitals
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAn 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 | ICU staff |
| psychological and sociological interviewsconducting 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. | Other | ICU staff |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Strain, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PS-ICU Scale Score (time frame: Through study completion, an average of 6 months after the epidemic peak). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.