NCT04358640

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

18 days

First QC Date

April 21, 2020

Last Update Submit

December 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Mesured by STAY Scale

    15 to 45 days after the beginning of the outbreak

Secondary Outcomes (2)

  • Insomnia

    15 to 45 days after the beginning of the outbreak

  • Catastrophism

    15 to 45 days after the beginning of the outbreak

Study Arms (1)

Employees of Nîmes University Hospital (France)

Employees of Nîmes University Hospital (France)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All employees of ICHU Nîmes participating to the present study will be sent a questionnaire for assessing the potential occurrence of anxiety This evaluation will be performed after the beginning of the outbreak (15 to 45 days)

You may qualify if:

  • Employees of CHU Nîmes during COVID-19 pandemic
  • Approved to participate

You may not qualify if:

  • Participation refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit CHU Nimes

Nîmes, 30029, France

Location

Related 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.

    PMID: 32112714BACKGROUND

MeSH Terms

Conditions

Critical IllnessCoronavirus InfectionsStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

April 9, 2020

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

December 19, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations