NCT06466993

Brief Summary

SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students. The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

June 14, 2024

Last Update Submit

August 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • PERFORMANCE

    Score at the objectif structured clinical examination exam from 0 minimum to 200 points maximum

    obtained seven days after the objectif structured clinical examination

Secondary Outcomes (2)

  • Mean Difference of Inner Resource

    Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)

  • Mean difference of perceived impact of the intervention on performance

    Just five minutes after the objectif structured clinical examination

Study Arms (2)

Intervention

EXPERIMENTAL

Relaxing breathing occuring during rotation of OSCE station

Behavioral: Intervention of standardized relaxing breathing

Control

ACTIVE COMPARATOR

Free time during rotation of OSCE station

Behavioral: Intervention of standardized relaxing breathing

Interventions

Relaxing breathing standardized to 6 respiratory cycles per minute that occur during rotation time before next station of OSCE start

ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all volontary medical students of the second cycle that came for their exam during the sessions of June 2024 from the University of Lyon (Medecine ESt)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gilles Rode, MD PhD

    Lyon Est Medical Center Lyon 1 University

    STUDY CHAIR
  • Evan Gouy, MD

    Lyon Est Medical Center Lyon 1 University

    PRINCIPAL INVESTIGATOR
  • Marion Cortet, MD PhD

    Lyon Est Medical Center Lyon 1 University

    STUDY DIRECTOR

Central Study Contacts

Marc Lilot, MD PhD

CONTACT

Sophie Schlatter, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Evaluators of performance are blind to randomisation such as outcome assessor
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective randomized controlle monocentric
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

September 5, 2024

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share