Stress ReactionNCT05393206
Influence of Medical Student Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of OSCE
An observational study of Stress Reaction and Coping Behavior, run by Claude Bernard University at 1 site in France.
Trial summary
Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Reaction, Coping Behavior, Exam Stress
- How many people
- 490 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2022to 19 Dec 2023
- 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: Fourth year medical student of the Claude Bernard University. All over eighteen years old.
Who may be able to join
- Fourth year medical student of Claude Bernard University participating to the OSCEs of May 2022
Who cannot join
- No signed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Medical Students Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of the OSCEs
Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress.
The differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress.
We will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.
Read the detailed description
This observational study will be conducted between the 17th and 19th of May at the Claude Bernard University (Lyon, France), during the OSCEs of the 4th year medical students. Their signed consent will be required before inclusion to the study.
Before the test begin, they will be given a few questionnaires to fill, including the Brief Cope Scale, visual analogous scales of their level of stress, level of confidence and level of resourcefulness. Coping methods are categorized in 4 types : positive thinking, active resolution, social support and avoidance. We will also ask them about their physical activity and their quality of sleep prior the OSCEs.
After the test, we will ask them once again their level of stress (visual analogous scale).
The main objective of this study is to demonstrate the link between the different methods of coping and the level of stress on the day of the OSCEs. Secondary objective is to have better insight and understanding over the relationship between coping methods and health-related problematics when linked to anxiety generated by exams.
All these data will be compared to a previous similar study conducted by our team of investigators on the same group of students, during their academical OSCEs in december 2021 (ECOSTRESS).
- Conditions
- Stress Reaction, Coping Behavior, Exam Stress, Sleep Hygiene, Physical Activity
- Keywords
- stress, coping, exam, medical students, sleep hygiene, physical activity
- Medical subject headings
- Fractures, Stress, Sleep Hygiene, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief cope scale
Brief Cope Scale level (from 2: minimum to 8 points : maximum) on the day of the OSCE
Measured: measured in the half-hour prior to the OSCEs
Secondary outcomes (6)
Coping and characterisation of stress
Correlation between coping methods according to BCS and characterisation of stress (from negative to positive, visual analogous scale) on the day of the OSCE
Measured: measured in the half-hour prior to the OSCEs
Coping and self-confidence
Correlation between coping methods according to BCS and the level of confidence (visual scale) on the day of the OSCE
Measured: measured in the half-hour prior to the OSCEs
Coping and inner resources
Correlation between coping methods according to BCS and the level of resourcefulness (visual scale) on the day of the OSCE (Spearman method)
Measured: measured in the half-hour prior to the OSCEs
Coping and physical activity
Correlation between coping methods according to BCS and the level of physical activity assessed by the GPAQ questionnaire (Global Physical Activity Questionnaire) in time of physical activity (minutes)
Measured: measured in the half-hour prior to (BCS) and in the half-hour after (GPAQ) the OSCEs
Coping and sleep quality
Correlation between coping methods according to BCS and the score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory)
Measured: measured in the half-hour prior to (BCS) and in the half-hour after (Pittsburgh Sleep Quality Index (PSQI from 0 minimum to 21 maximum)) the OSCEs
Link between sleep quality and stress
Correlation between score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory) and the level of stress (visual analogous scale) on the day of the OSCE
Measured: measured in the half-hour prior to (stress level) and in the half-hour after (PSQI) the OSCEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start16 May 2022
- Primary completion19 Jun 2022
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ReactionStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Gilles Rodes, Ph.D, Study chair, Claude Bernard UniversityMarc Lilot, PhD, Study director, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393206
- Sponsor's protocol ID
- Cope&stress
- Status last verified
- Jun 2024
- First submitted
- 13 May 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barret N, Guillaumee T, Rimmele T, Cortet M, Mazza S, Duclos A, Rode G, Lilot M, Schlatter S. Associations of coping and health-related behaviors with medical students' well-being and performance during objective structured clinical examination. Sci Rep. 2024 May 17;14(1):11298. doi: 10.1038/s41598-024-61800-1.
PubMed 38760478
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medical Students Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of the OSCEs
- ClinicalTrials.gov ID
- NCT05393206
- Acronym / sponsor ID
- Cope&stress
- Conditions
- Stress Reaction, Coping Behavior, Exam Stress, Sleep Hygiene, Physical Activity
- Keywords
- stress, coping, exam, medical students, sleep hygiene, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 19 Jun 2022 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 26 May 2022 (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.
Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress.
The differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress.
We will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.
Detailed description
This observational study will be conducted between the 17th and 19th of May at the Claude Bernard University (Lyon, France), during the OSCEs of the 4th year medical students. Their signed consent will be required before inclusion to the study.
Before the test begin, they will be given a few questionnaires to fill, including the Brief Cope Scale, visual analogous scales of their level of stress, level of confidence and level of resourcefulness. Coping methods are categorized in 4 types : positive thinking, active resolution, social support and avoidance. We will also ask them about their physical activity and their quality of sleep prior the OSCEs.
After the test, we will ask them once again their level of stress (visual analogous scale).
The main objective of this study is to demonstrate the link between the different methods of coping and the level of stress on the day of the OSCEs. Secondary objective is to have better insight and understanding over the relationship between coping methods and health-related problematics when linked to anxiety generated by exams.
All these data will be compared to a previous similar study conducted by our team of investigators on the same group of students, during their academical OSCEs in december 2021 (ECOSTRESS).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fourth year medical student of the Claude Bernard University. All over eighteen years old.
Key inclusion criteria (1 listed)
- Fourth year medical student of Claude Bernard University participating to the OSCEs of May 2022
Key exclusion criteria (1 listed)
- No signed consent
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
Brief cope scale
Time frame: measured in the half-hour prior to the OSCEs
Brief Cope Scale level (from 2: minimum to 8 points : maximum) on the day of the OSCE
6 secondary outcomes
Coping and characterisation of stress
Time frame: measured in the half-hour prior to the OSCEs
Coping and self-confidence
Time frame: measured in the half-hour prior to the OSCEs
Coping and inner resources
Time frame: measured in the half-hour prior to the OSCEs
Coping and physical activity
Time frame: measured in the half-hour prior to (BCS) and in the half-hour after (GPAQ) the OSCEs
Coping and sleep quality
Time frame: measured in the half-hour prior to (BCS) and in the half-hour after (Pittsburgh Sleep Quality Index (PSQI from 0 minimum to 21 maximum)) the OSCEs
Link between sleep quality and stress
Time frame: measured in the half-hour prior to (stress level) and in the half-hour after (PSQI) the OSCEs
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 18 Jun 2024.
- Derived from this study: PubMed 38760478Barret N, Guillaumee T, Rimmele T, Cortet M, Mazza S, Duclos A, Rode G, Lilot M, Schlatter S. Associations of coping and health-related behaviors with medical students' well-being and performance during objective structured clinical examination. Sci Rep. 2024 May 17;14(1):11298. doi: 10.1038/s41598-024-61800-1.
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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.
Gilles Rodes, Ph.D study chair
Claude Bernard University
Marc Lilot, PhD study director
Claude Bernard University
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 Reaction and Coping Behavior, run by Claude Bernard University 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 1 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 18 Jun 2024. 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?
Brief cope scale (time frame: measured in the half-hour prior to the OSCEs). 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 NCT05393206, which also lists 1 linked publication.
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 18 Jun 2024.