- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383886
Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic (COVER-PRO)
In the context of the COVID-19 pandemic, Emergency Department (ED) are in front line for the reception of patients presenting COVID-19 symptoms and have to face a new situation given the expected number of patients. Staff participate in suspect patients triage, in the diagnosis and the management of Covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. This situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. Then; they are subject to many stress and anxiety factors such as:
- Increased activity: massive influx of patients, overload of work, lack of material and human resources
- Modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments
- Ethical dilemma: decisions to be made in an emergency, patient prioritization
- Numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media)
- Individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support
- Anxiety and stress management of patients and relatives, their entourage and colleagues In this study, it is proposed to study the psychic impact of the COVID-19 pandemic on emergency department staff.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69003
- SAMU Hospices Civils de Lyon
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Lyon, France, 69003
- Service d'accueil des urgences, Hôpital Edouard Herriot, Hospices Civlis de Lyon
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Lyon, France, 69004
- Service d'accueil des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
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Pierre-Bénite, France, 69310
- Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon
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Villefranche-sur-Saône, France, 69400
- Hôpital de Villefranche-sur-Saône
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults
- medical and paramedical staff working the the emergency room permanently or specifically during the COVID19 pandemic
- not opposed to participate to this study
Exclusion Criteria:
- Staff under legal protection
- refusing to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Emergency department staff
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Emergency department staff will be asked to fill in questionnaires in order to measure their stress and anxiety level, their propensity to have a burn-out, their consumption of psychoactive substances such as alcohol, tobacco, coffee or anxiolytic, their sleep disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of emergency department staff's level of stress during the covid19 pandemic, measured using the Chamoux et Simard visual analogic scale
Time Frame: Every 15 days from baseline to 3 months
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The level of stress will be measured using the Chamoux et Simard visual analogic scale.
This scale is composed of 3 subscales evaluating the stress level at work, at home and in the life in general.
Each scale are rating from 0 to 10, 0 being the absence of stress and 10 the highest level of stress ever experienced a cotation at each scale greater than 6 will defined the presence of a stress.
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Every 15 days from baseline to 3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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