Emergency Department Staff During the COVID-19 PandemicCOVER-PRONCT04383886
Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic
An observational study of Emergency Department Staff During the COVID-19 Pandemic and Emergency Department Staff's Level of Stress, run by Hospices Civils de Lyon at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department Staff During the COVID-19 Pandemic, Emergency Department Staff's Level of Stress
- What is being tested?
- stress and anxiety questionnaire
- How many people
- 247 participants
- Where
- 5 sitesFrance
- Study dates
- 18 Apr 2020to 12 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department staff
Who may be able to join
- Adults
- medical and paramedical staff working the the emergency room permanently or specifically during the COVID19 pandemic
- not opposed to participate to this study
Who cannot join
- Staff under legal protection
- refusing to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
SAMU Hospices Civils de Lyon
Lyon, 69003
Service d'accueil des urgences, Hôpital Edouard Herriot, Hospices Civlis de Lyon
Lyon, 69003
Service d'accueil des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
Hôpital de Villefranche-sur-Saône
Villefranche-sur-Saône, 69400
About this study
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.
- Conditions
- Emergency Department Staff During the COVID-19 Pandemic, Emergency Department Staff's Level of Stress
- Being tested
- stress and anxiety questionnaire
- Keywords
- COVID-19 pandemic, level of stress, emergency department staff
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress and anxiety questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Emergency department staff | Not described Receives: Other: stress and anxiety questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 15 days from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start18 Apr 2020
- Primary completion12 Sep 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergency Department Staff During the COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383886
- Sponsor's protocol ID
- 69HCL20_0330
- Acronym
- COVER-PRO
- Status last verified
- Apr 2023
- First submitted
- 8 May 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douplat M, Subtil F, Termoz A, Jacquin L, Verbois F, Potinet V, Hernu R, Landel V, Mazza S, Berthiller J, Haesebaert J, Tazarourte K. Mental Health Consequences of the COVID-19 Outbreak Among Emergency Department Healthcare Workers. Biomed Res Int. 2024 Sep 9;2024:8871959. doi: 10.1155/2024/8871959. eCollection 2024.
PubMed 39286281Douplat M, Termoz A, Subtil F, Haesebaert J, Jacquin L, Durand G, Potinet V, Hernu R, Nohales L, Mazza S, Berthiller J, Tazarourte K. Changes over time in anxiety, depression, and stress symptoms among healthcare workers in French emergency departments during the first COVID-19 outbreak. J Affect Disord. 2022 Nov 1;316:194-200. doi: 10.1016/j.jad.2022.08.028. Epub 2022 Aug 15.
PubMed 35981626
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04383886
- Acronym / sponsor ID
- COVER-PRO / 69HCL20_0330
- Conditions
- Emergency Department Staff During the COVID-19 Pandemic, Emergency Department Staff's Level of Stress
- Keywords
- COVID-19 pandemic, level of stress, emergency department staff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency department staff | – | Other: stress and anxiety questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department staff
Key inclusion criteria (3 listed)
- Adults
- medical and paramedical staff working the the emergency room permanently or specifically during the COVID19 pandemic
- not opposed to participate to this study
Key exclusion criteria (2 listed)
- Staff under legal protection
- refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress and anxiety questionnaireEmergency 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. | Other | Emergency department staff |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 39286281Douplat M, Subtil F, Termoz A, Jacquin L, Verbois F, Potinet V, Hernu R, Landel V, Mazza S, Berthiller J, Haesebaert J, Tazarourte K. Mental Health Consequences of the COVID-19 Outbreak Among Emergency Department Healthcare Workers. Biomed Res Int. 2024 Sep 9;2024:8871959. doi: 10.1155/2024/8871959. eCollection 2024.
- Derived from this study: PubMed 35981626Douplat M, Termoz A, Subtil F, Haesebaert J, Jacquin L, Durand G, Potinet V, Hernu R, Nohales L, Mazza S, Berthiller J, Tazarourte K. Changes over time in anxiety, depression, and stress symptoms among healthcare workers in French emergency departments during the first COVID-19 outbreak. J Affect Disord. 2022 Nov 1;316:194-200. doi: 10.1016/j.jad.2022.08.028. Epub 2022 Aug 15.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Department Staff During the COVID-19 Pandemic and Emergency Department Staff's Level of Stress, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.