StressNCT04780113
Evolution of Perceived Stress in General Practice Residents During COVID-19 Sanitary Crisis
An observational study of Stress, run by Centre Hospitalier Eure-Seine at 1 site in France.
Trial summary
Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2021to 24 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants being general practice residents in Caen or Rouen
Who may be able to join
- Being a general practice resident in Rouen or Caen
- Participant informed and non-objection of him/her
Who cannot join
- Being on maternity leave or not working during the period concerned with the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Evolution of Perceived Stress in General Practice Residents of Rouen and Caen During COVID-19 Sanitary Crisis
Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.
Read the detailed description
This prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in France, Rouen and Caen. The two questionnaires contain the Perceived Stress Scale, as well as items regarding socio-demographic data and stress factors. The first questionnaire is to be distributed during the epidemic COVID-19 wave and the second questionnaire at the end of the epidemic COVID-19 wave.
- Conditions
- Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19
The perceived stress will be evaluated using the Perceived Stress Scale. This scale contains 10 items, with scores ranging from 0 to 40, with higher scores meaning a higher level of stress.
Measured: maximum 6 months, according to the evolution of the epidemic
Secondary outcomes (2)
Description of general characteristics of residents and their feelings and experiences with the sanitary crisis
This include socio-demographic characteristics, work-related information and potential stress factors
Measured: maximum 6 months, according to the evolution of the epidemic
Assessment of residents' profile stress according to their socio-demographic and working characteristics
Identification of stress factors among residents
Measured: maximum 6 months, according to the evolution of the epidemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start25 Feb 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Eure-Seine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ségolène Guillemette, MD, Principal investigator, General Practice Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780113
- Sponsor's protocol ID
- 2020-A03283-36
- Other IDs
- CHES N°20/01
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Evolution of Perceived Stress in General Practice Residents of Rouen and Caen During COVID-19 Sanitary Crisis
- ClinicalTrials.gov ID
- NCT04780113
- Acronym / sponsor ID
- 2020-A03283-36
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Centre Hospitalier Eure-SeineUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 3 Mar 2021 (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.
Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.
Detailed description
This prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in France, Rouen and Caen. The two questionnaires contain the Perceived Stress Scale, as well as items regarding socio-demographic data and stress factors. The first questionnaire is to be distributed during the epidemic COVID-19 wave and the second questionnaire at the end of the epidemic COVID-19 wave.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants being general practice residents in Caen or Rouen
Key inclusion criteria (2 listed)
- Being a general practice resident in Rouen or Caen
- Participant informed and non-objection of him/her
Key exclusion criteria (1 listed)
- Being on maternity leave or not working during the period concerned with the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19
Time frame: maximum 6 months, according to the evolution of the epidemic
The perceived stress will be evaluated using the Perceived Stress Scale. This scale contains 10 items, with scores ranging from 0 to 40, with higher scores meaning a higher level of stress.
2 secondary outcomes
Description of general characteristics of residents and their feelings and experiences with the sanitary crisis
Time frame: maximum 6 months, according to the evolution of the epidemic
Assessment of residents' profile stress according to their socio-demographic and working characteristics
Time frame: maximum 6 months, according to the evolution of the epidemic
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 22 Apr 2022.
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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.
Ségolène Guillemette, MD principal investigator
General Practice Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Centre Hospitalier Eure-Seine at 1 site 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 2 inclusion and 1 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19 (time frame: maximum 6 months, according to the evolution of the epidemic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.