StressFORSENCT06404255
Impact of a Stress Management Training Course
An observational study of Stress, run by Université Paris-Saclay.
Trial summary
Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Stress management training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Medical students from Paris Saclay University, during hospital internships
Who may be able to join
- Medical students from Paris Saclay University, during hospital internships
- Agreeing to take part in the study
Who cannot join
- Refusal to participate in the study
About this study
Official title: Evaluating the Impact of a Stress Management Training Course for ECOS Preparation for Medical Students
Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.
Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.
Read more
The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.
The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.
Read the detailed description
Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.
Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.
Anxiety can affect students' performance, although not all studies have found a significant correlation between results and students' state of anxiety.
However, it is essential to take account of students' well-being, especially as it has been shown that medical students suffer from symptoms of anxiety and depression, some of which may be related to their studies.
It is therefore important to reduce these symptoms of anxiety in order to improve students' well-being, and eventually their performance during ECOS.
A number of studies have looked at ways of reducing student anxiety, including breathing relaxation techniques and anxiety management programs. Preparation, stress management and self-confidence can have a calming effect, and may even have a positive impact on exam performance.
The visual analog stress scale and the STAI questionnaire are two validated and commonly used methods for stress assessment. The investigators modified the visual scale to assess the functional impact of stress on ECOS performance.
The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.
The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.
- Conditions
- Stress
- Being tested
- Stress management training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress management trainingBehavioural
Stress management training
| Study group | Role | What they receive |
|---|---|---|
| Medical students | Medical students from the University of Paris-Saclay, during hospital internships Stress assessement with or without a stress management training Receives: Behavioral: Stress management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional impact of stress after ECOS
Score for the functional impact of stress after ECOS, with or without stress management training From 0 = No negative impact of stress on ECOS performance To 10 = Extremely negative impact of stress on ECOS performance
Measured: 3 years
Secondary outcomes (2)
Anxiety score
Anxiety score on STAI (State and Trait Anxiety Inventory) after ECOS, with or without stress management training From 0 = no anxiety To 40 = very high anxiety
Measured: 3 years
ECOS scores
ECOS scores, with or without stress management training From 0 = lowest score To 10 = highest score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2027 (estimated)
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris-Saclay
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillemette Fouquet, Université Paris-Saclay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404255
- Sponsor's protocol ID
- FORSE_001
- Acronym
- FORSE
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Stress Management Training Course for ECOS Preparation for Medical Students
- ClinicalTrials.gov ID
- NCT06404255
- Acronym / sponsor ID
- FORSE / FORSE_001
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université Paris-SaclayUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 8 May 2024 (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 (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.
Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.
The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.
The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.
Detailed description
Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.
Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.
Anxiety can affect students' performance, although not all studies have found a significant correlation between results and students' state of anxiety.
However, it is essential to take account of students' well-being, especially as it has been shown that medical students suffer from symptoms of anxiety and depression, some of which may be related to their studies.
It is therefore important to reduce these symptoms of anxiety in order to improve students' well-being, and eventually their performance during ECOS.
A number of studies have looked at ways of reducing student anxiety, including breathing relaxation techniques and anxiety management programs. Preparation, stress management and self-confidence can have a calming effect, and may even have a positive impact on exam performance.
The visual analog stress scale and the STAI questionnaire are two validated and commonly used methods for stress assessment. The investigators modified the visual scale to assess the functional impact of stress on ECOS performance.
The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.
The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical students | – | Behavioral: Stress management trainingMedical students from the University of Paris-Saclay, during hospital internships Stress assessement with or without a stress management training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Medical students from Paris Saclay University, during hospital internships
Key inclusion criteria (2 listed)
- Medical students from Paris Saclay University, during hospital internships
- Agreeing to take part in the study
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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 management trainingStress management training | Behavioural | Medical students |
Primary outcome
Functional impact of stress after ECOS
Time frame: 3 years
Score for the functional impact of stress after ECOS, with or without stress management training From 0 = No negative impact of stress on ECOS performance To 10 = Extremely negative impact of stress on ECOS performance
2 secondary outcomes
Anxiety score
Time frame: 3 years
ECOS scores
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Université Paris-Saclay.
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: opening soon, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Functional impact of stress after ECOS (time frame: 3 years). 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 8 May 2024.