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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress, Psychological, Stress, Physiological, Exam Stress, Performance Anxiety, Rumination

Intervention / Treatment
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* Other: Biofeedback
* Other: Meditation
* Other: Control and biofeedback post OSCE
* Other: Control and control post OSCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult person Registered as medical student at the university Participating at OSCE examination Have signed an informed consent form. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 parallels groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after | Other: Biofeedback<br>* 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.<br>* Other names: Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after;|
| Experimental: Meditation<br>Meditative stimulation audio tape before the circuit, no intervention after | Other: Meditation<br>* 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.<br>* Other names: Meditative stimulation audio tape before the circuit, no intervention after;|
| Experimental: Control and biofeedback post OSCE<br>Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE | Other: Control and biofeedback post OSCE<br>* 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<br>* Other names: Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after;|
| Sham Comparator: Control and control post OSCE<br>Standardised video before the circuit, no intervention after | Other: Control and control post OSCE<br>* 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.<br>* Other names: Standardised video before the circuit, no intervention after;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress management and performance, Medical education