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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04358640
Other study ID # LOCAL COVID 2019/JYL-01)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2020
Est. completion date April 27, 2020

Study information

Verified date December 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed


Recruitment information / eligibility

Status Completed
Enrollment 1784
Est. completion date April 27, 2020
Est. primary completion date April 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Employees of CHU Nîmes during COVID-19 pandemic - Approved to participate Exclusion Criteria: • Participation refusal

Study Design


Locations

Country Name City State
France Intensive care unit CHU Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (1)

Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Mesured by STAY Scale 15 to 45 days after the beginning of the outbreak
Secondary Insomnia Participant suffering of Insomnia 15 to 45 days after the beginning of the outbreak
Secondary Catastrophism Participant suffering of catastrophism 15 to 45 days after the beginning of the outbreak
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