Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students (ECOSTRESS)

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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Stress, Physiological; Rumination; Exam Stress; Performance Anxiety
• Intervention / Treatment: Other: Biofeedback; Other: Meditation; Other: Control and biofeedback post OSCE; Other: Control and control post OSCE

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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Marc lilot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback; Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after	Other: Biofeedback; 6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instruction.; Other Names: Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Experimental: Meditation; Meditative stimulation audio tape before the circuit, no intervention after	Other: Meditation; 6 minutes of listening an audio tape made for the study that inspire mindfulness like meditation associated with psychological stimulation (positive encouragement) just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instructions.; Other Names: Meditative stimulation audio tape before the circuit, no intervention after
Experimental: Control and biofeedback post OSCE; Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE	Other: Control and biofeedback post OSCE; 6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer; Other Names: Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Sham Comparator: Control and control post OSCE; Standardised video before the circuit, no intervention after	Other: Control and control post OSCE; 6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of of free activity where the participants will not be given any instruction.; Other Names: Standardised video before the circuit, no intervention after

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Performance	The performance is student grade at the exam, as determined by university evaluator	During the first 2 hours of the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of Physiological stress	Heart rate variation collected by emWave® devices	During the first 2 hours of the inclusion
Differences of Psychological stress	Numerical Visual analog scales (VAS) on perceived stress from zero to 100: maximum Numerical VAS on resourcefulness nedeed an avalaible perceived from zero to maximum	Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Difference of Resourcefulness	Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum	Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Characterisation of stress	Numerical VAS on characterisation of stress perceived from negative to positive	Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Differences of Self confidence	Numerical VAS on self confidence perceived from zero to 100: maximum	Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Differences of Psychological stress consequences	Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness	Three times : before first intervention, before OSCE circuit, just after second intervention
Differences of Ruminations	Brief rumination scale questionnaire	Just after second intervention at the end of the OSCE
Individual psychological characteristics	Personality traits (Big-5)	Just after second intervention at the end of the OSCE

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Investigators: Study Chair: Gilles Rode, M.D., Ph.D., Claude Bernard University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Medical education; Stress management and performance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 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