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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04383886
Other study ID # 69HCL20_0330
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 18, 2020
Est. completion date September 12, 2020

Study information

Verified date April 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date September 12, 2020
Est. primary completion date September 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
stress and anxiety questionnaire
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.

Locations

Country Name City State
France SAMU Hospices Civils de Lyon Lyon
France Service d'accueil des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon Lyon
France Service d'accueil des urgences, Hôpital Edouard Herriot, Hospices Civlis de Lyon Lyon
France Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon Pierre-Bénite
France Hôpital de Villefranche-sur-Saône Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of emergency department staff's level of stress during the covid19 pandemic, measured using the Chamoux et Simard visual analogic scale 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. Every 15 days from baseline to 3 months