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

November 14, 2023 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Jean-Baptiste BOUILLON-MINOIS
    • Auvergne-Rhone-Alpes
      • Clermont-Ferrand, Auvergne-Rhone-Alpes, France, 63000
        • Recruiting
        • Medical School of Clermont-Ferrand
        • Contact:
        • Sub-Investigator:
          • Alexandre Lautrette, MD, PhD
        • Sub-Investigator:
          • Frédéric Dutheil, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Medical student between fourth and sixth year of med school

Description

Inclusion Criteria:

  • All medical student that agree to participate

Exclusion Criteria:

  • All medical student that disagree to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability (HRV)
Time Frame: 24 hours
Comparison of heart rate variability during one day of OSCE versus a traditional table examination.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic
Time Frame: Once
Study of factors influencing heart rate variability (time of passage, anticipatory stress, sociodemographic, or lifestyle habits).
Once
Subjective stress
Time Frame: 12 hours
Study of stress using visual analogic scale (VAS)
12 hours
Stress correlation
Time Frame: Once
Study of correlation between subjective stress (VAS) and objective stress (HRV)
Once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2023

Primary Completion (Estimated)

June 29, 2030

Study Completion (Estimated)

June 29, 2030

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023BOUILLON-MINOIS-ECOSTRESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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