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The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT06138457
Collaborator
(none)
100
Enrollment
2
Locations
84
Anticipated Duration (Months)
50
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
    Actual Study Start Date :
    Jun 29, 2023
    Anticipated Primary Completion Date :
    Jun 29, 2030
    Anticipated Study Completion Date :
    Jun 29, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Heart Rate Variability (HRV) [24 hours]

      Comparison of heart rate variability during one day of OSCE versus a traditional table examination.

    Secondary Outcome Measures

    1. Sociodemographic [Once]

      Study of factors influencing heart rate variability (time of passage, anticipatory stress, sociodemographic, or lifestyle habits).

    2. Subjective stress [12 hours]

      Study of stress using visual analogic scale (VAS)

    3. Stress correlation [Once]

      Study of correlation between subjective stress (VAS) and objective stress (HRV)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All medical student that agree to participate
    Exclusion Criteria:
    • All medical student that disagree to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical School of Clermont-Ferrand Clermont-Ferrand Auvergne-Rhone-Alpes France 63000
    2 CHU clermont-ferrand Clermont-Ferrand France

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    • Principal Investigator: Jean-Baptiste BOUILLON-MINOIS, University Hospital, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT06138457
    Other Study ID Numbers:
    • 2023BOUILLON-MINOIS-ECOSTRESS
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    stress
    exam
    medical student
    heart rate variability

    Study Results

    No Results Posted as of Nov 18, 2023