Covid19 Clinical Trial
— EMOCOVOfficial title:
Post-Covid-19 Emotional Aspects of Hospital Staff
NCT number | NCT04794920 |
Other study ID # | EMOCOV |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 10, 2020 |
Est. completion date | January 9, 2023 |
Verified date | April 2023 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic. Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system. The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health. The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic. Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).
Status | Completed |
Enrollment | 780 |
Est. completion date | January 9, 2023 |
Est. primary completion date | October 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period. Exclusion Criteria: - Opposition to participate in research. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint-Joseph | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e02670 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020). | Rate of staff with a score> 44 on the PCL questionnaire | Day 1 | |
Primary | Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020). | Rate of staff with a score =11 on items A and D for the HAD score | Day 1 | |
Secondary | Look for demographic and professional characteristics that may favor the onset of these symptoms | Univariate and multivariate analyzes to identify the risk factors for the occurrence of these symptoms (anxiety, depression and post-traumatic stress) | Day 1 | |
Secondary | Evaluate the impact of frequentation of the staff bubble on the occurrence of anxiety / depressive disorders | Difference between the average HAD scores between the group "frequentation of the staff bubble" and the group "non-attendance of the staff bubble". The distinction between the 2 groups is made on the basis of their answer to the dedicated question asked in the questionnaire. | Day 1 | |
Secondary | Evaluate the impact of frequentation of the staff bubble on the occurrence of post-traumatic stress | Difference between the mean PCL scores between the 2 above-mentioned groups | Day 1 | |
Secondary | Evaluate the impact of the psychological support unit on the occurrence of anxiety / depressive disorders | Difference between the average HAD scores between the "contact with the psychological support unit" group and the "no contact with the psychological support unit" group. The distinction between the 2 groups is made on the basis of their response to the question asked in the questionnaire. | Day 1 | |
Secondary | Evaluate the impact of the psychological support unit on the occurrence of post traumatic stress | Difference between the mean PCL scores between the 2 above-mentioned groups | Day 1 | |
Secondary | Evaluate the benefit felt by staff from frequenting the staff bubble | In the group "frequentation of the staff bubble": percentage of response "Very beneficial" or "Quite beneficial" | Day 1 | |
Secondary | Evaluate the benefit felt by the staff of the meeting with the psychological support unit | In the group "meeting with the psychological support unit": percentage of response "Very beneficial" or "Quite beneficial" | Day 1 |
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