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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06138457
Other study ID # 2023BOUILLON-MINOIS-ECOSTRESS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 29, 2023
Est. completion date June 29, 2030

Study information

Verified date November 2023
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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...).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 29, 2030
Est. primary completion date June 29, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All medical student that agree to participate Exclusion Criteria: - All medical student that disagree to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand
France Medical School of Clermont-Ferrand Clermont-Ferrand Auvergne-Rhone-Alpes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart Rate Variability (HRV) Comparison of heart rate variability during one day of OSCE versus a traditional table examination. 24 hours
Secondary Sociodemographic Study of factors influencing heart rate variability (time of passage, anticipatory stress, sociodemographic, or lifestyle habits). Once
Secondary Subjective stress Study of stress using visual analogic scale (VAS) 12 hours
Secondary Stress correlation Study of correlation between subjective stress (VAS) and objective stress (HRV) Once
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