Heart Rate VariabilityECOSTRESSNCT06138457
The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
An observational study of Heart Rate Variability and Stress, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Stress, Medical Student
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jun 2023to 29 Jun 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical student between fourth and sixth year of med school
Who may be able to join
- All medical student that agree to participate
Who cannot join
- All medical student that disagree to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Medical School of Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000
Jean-Baptiste Bouillon-Minois, MD, PhD, +33 4 73 75 19 99, jbbouillon-minois@chu-clermontferrand.fr
Alexandre Lautrette, MD, PhD
- Not yet recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Jean-Baptiste BOUILLON-MINOIS
About this study
We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day.
Read the detailed description
French medical students have benefited from a new evaluation method since 2020 in the form of a standardized objective clinical examination (OSCE). This examination consists of an evaluation of an initial clinical situation, in relation to a pre-identified and nationally identical objective in all Medical School. During these exams, the student has one minute of preparation then seven minutes of evaluation in front of a facilitator, member of the teaching staff. An examiner is also present in the room to search in real time for keywords intended for grading. The examiner and facilitator may or may not be tenured teachers. Students benefit from annual training organized by the Medical School of Clermont-Ferrand in which they all participate. This exam appears to be excessively stressful for students. However, there is currently no data regarding the objective measurement of the stress of these students. Heart rate variability is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc...).
- Conditions
- Heart Rate Variability, Stress, Medical Student
- Keywords
- stress, exam, medical student, heart rate variability
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
Comparison of heart rate variability during one day of OSCE versus a traditional table examination.
Measured: 24 hours
Secondary outcomes (3)
Sociodemographic
Study of factors influencing heart rate variability (time of passage, anticipatory stress, sociodemographic, or lifestyle habits).
Measured: Once
Subjective stress
Study of stress using visual analogic scale (VAS)
Measured: 12 hours
Stress correlation
Study of correlation between subjective stress (VAS) and objective stress (HRV)
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start29 Jun 2023
- Primary completion29 Jun 2030 (estimated)
- Study completion29 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste BOUILLON-MINOIS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138457
- Sponsor's protocol ID
- 2023BOUILLON-MINOIS-ECOSTRESS
- Acronym
- ECOSTRESS
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
- ClinicalTrials.gov ID
- NCT06138457
- Acronym / sponsor ID
- ECOSTRESS / 2023BOUILLON-MINOIS-ECOSTRESS
- Conditions
- Heart Rate Variability, Stress, Medical Student
- Keywords
- stress, exam, medical student, heart rate variability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 29 Jun 2030 (estimated)
- Study completion
- 29 Jun 2030 (estimated)
- First posted
- 18 Nov 2023 (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.
We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day.
Detailed description
French medical students have benefited from a new evaluation method since 2020 in the form of a standardized objective clinical examination (OSCE). This examination consists of an evaluation of an initial clinical situation, in relation to a pre-identified and nationally identical objective in all Medical School. During these exams, the student has one minute of preparation then seven minutes of evaluation in front of a facilitator, member of the teaching staff. An examiner is also present in the room to search in real time for keywords intended for grading. The examiner and facilitator may or may not be tenured teachers. Students benefit from annual training organized by the Medical School of Clermont-Ferrand in which they all participate. This exam appears to be excessively stressful for students. However, there is currently no data regarding the objective measurement of the stress of these students. Heart rate variability is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc...).
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
- Medical student between fourth and sixth year of med school
Key inclusion criteria (1 listed)
- All medical student that agree to participate
Key exclusion criteria (1 listed)
- All medical student that disagree 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.
Primary outcome
Heart Rate Variability (HRV)
Time frame: 24 hours
Comparison of heart rate variability during one day of OSCE versus a traditional table examination.
3 secondary outcomes
Sociodemographic
Time frame: Once
Subjective stress
Time frame: 12 hours
Stress correlation
Time frame: Once
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 18 Nov 2023.
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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.
Jean-Baptiste BOUILLON-MINOIS principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability and Stress, run by University Hospital, Clermont-Ferrand at 2 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 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: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) (time frame: 24 hours). 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 18 Nov 2023.