NCT06138457

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
50mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jun 2023Jun 2030

Study Start

First participant enrolled

June 29, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2030

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

7 years

First QC Date

November 14, 2023

Last Update Submit

November 14, 2023

Conditions

Heart Rate VariabilityStressMedical Student

Keywords

stressexammedical studentheart rate variability

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability (HRV)

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

    24 hours

Secondary Outcomes (3)

  • Sociodemographic

    Once

  • Subjective stress

    12 hours

  • Stress correlation

    Once

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical student between fourth and sixth year of med school

You may qualify if:

  • All medical student that agree to participate

You may not qualify if:

  • All medical student that disagree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical School of Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

Study Officials

  • Jean-Baptiste BOUILLON-MINOIS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

June 29, 2023

Primary Completion (Estimated)

June 29, 2030

Study Completion (Estimated)

June 29, 2030

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

FR(2)