Clinical trial NCT05136586: Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students
Official title: Effects of Two Stress Management Procedures on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students : Relaxing Breathing Combined With Biofeedback or Meditative Stimulation : ECOSTRESS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Exam Stress
Performance Anxiety
Rumination
Keywords: Stress management and performance
Medical education
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 parallels groups
Primary purpose: OTHER

Brief summary: Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical student and is a determinant part of the national competition they have to undergo.

Medical studies, especially during examen period, are significantly associated with risk of developping depressions or anxious trouble, wich led to lesser performance, impaired memorization and impaired workload capacities.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback and meditation are procedures used to reduce the stress level.

There is currently no study on the effect of stress management procedures on the performance during OSCE for medical student.

Detailed description: This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical student. For examination purpose, the students will be divided in four groups that will undergo identical exam in the same time in four parallels circuits.

Before entering the circuit, all the students will received information for the study and sign consent.

All the students will be equipped with emWAve® devices that allows us to collect heart rate variability as physiological stress marker during the time of the intervention. Participants will undergo short questionnaires regarding perceived stress.

Then the groups of students will be randomized in four interventions groups for receiving a combination of intervention before and/or after the examination circuit. All the interventions last six minutes long. The randomisation groups are :

* Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
* Meditative stimulation audio tape before the circuit, no intervention after
* Standardised video as controlled group before the circuit and a relaxing breathing exercise coupled with biofeedback after
* Standardised video as controlled group before and not intervention after

At the end of the examination circuit, all the students will undergo short questionnaires regarding stress, participants will get equipped with emWAve ® devices again and participants will get the second intervention depending on the randomisation group.

Main objective is to show that relaxing breathing exercise coupled with biofeedback or meditative stimulation is better than an standardised video on performance during OSCE.

The main outcome is student grade at the exam, as determined by university evaluator who is blind to the intervention and with no links to the study.

Secondary objectives are to compare the effects of the interventions on measured physiological stress, psychological stress, and negative rumination.

Eligibility criteria: Inclusion Criteria:

* Adult person
* Registered as medical student at the university
* Participating at OSCE examination
* Have signed an informed consent form.

Exclusion Criteria:

* None

Primary outcomes:
measure: Differences in Performance
timeFrame: During the first 2 hours of the inclusion
Secondary outcomes:
measure: Differences of Physiological stress
timeFrame: During the first 2 hours of the inclusion
measure: Differences of Psychological stress
timeFrame: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
measure: Difference of Resourcefulness
timeFrame: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
measure: Characterisation of stress
timeFrame: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
measure: Differences of Self confidence
timeFrame: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
measure: Differences of Psychological stress consequences
timeFrame: Three times : before first intervention, before OSCE circuit, just after second intervention
measure: Differences of Ruminations
timeFrame: Just after second intervention at the end of the OSCE
measure: Individual psychological characteristics
timeFrame: Just after second intervention at the end of the OSCE
Other outcomes:
Locations:
city: Lyon
country: France
facility: Marc lilot
Study officials:
affiliation: Claude Bernard University
name: Gilles Rode, M.D., Ph.D.
role: STUDY_CHAIR
References: