Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students

Study Overview
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Brief Summary
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Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students. Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.

Detailed Description
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This randomized, controlled and monocentric study will be conducted during the OSCE tests contributing towards the final exam grades for 4th year medicine students at the Claude Bernard Lyon 1 university.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long. The randomisation groups are: Mindfulness through watching/listening video tape Mobilization of inner resources through watching/listening video tape Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score Unemotional video tape as controlled group Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality. Main objective is to show that interventions are better than control to reduce stress level before OSCE. The main outcome is to compare the effect of the interventions on physiological stress, using HRV as physiological stress marker. Secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. Finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.

Official Title
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Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students

Conditions
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Exam Stress, Stress, Psychological, Stress, Physiological

Intervention / Treatment
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* Other: Mindfulness meditation
* Other: Mobilization of inner resources
* Other: Biofeedback


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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 parallel groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Mindfulness meditation video before the circuit | Other: Mindfulness meditation<br>* 6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.<br>|
| Experimental: Mobilization of inner resources<br>Standardised video before the circuit | Other: Mobilization of inner resources<br>* 6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit<br>|
| Experimental: Biofeedback<br>Cardiac biofeedback before the circuit | Other: Biofeedback<br>* 6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit.<br>|
| Sham Comparator: Control<br>Standardised video before the circuit | Other: Mindfulness meditation<br>* 6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.<br>Other: Mobilization of inner resources<br>* 6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit<br>Other: Biofeedback<br>* 6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of physiological stress | Heart rate variability collected by an ear pulse sensor (emWave® device) | During the 6min long intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of the influence of the intervention on Psychological stress | Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum) | measured two times: just 30 seconds before and after the intervention | 
| Characterisation of the influence of the intervention on Psychological stress | Numerical 100mm-VAS on characterisation of the quality of the perceived stress (from negative stress to positive stress, 50 mm (center) is considered no influence) | measured two times: just 30 seconds before and after the intervention | 
| Characterisation of the influence of the intervention on level of inner resources | Numerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum) | measured two times: just 30 seconds before and after the intervention | 
| Characterisation of the influence of the intervention on self-confidence | Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum) | measured two times: just 30 seconds before and after the intervention | 
| Characterisation of intervention on Psychological stress consequences | Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation). | measured two times: just 1 minute before and after the intervention | 
| Feelings about the intervention | Likert Scale assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun) on a 5 items answers (from not feeling at all, to very importante intensity) | just 2 minutes after the intervention | 
| Determining influence of personality traits on the efficiency on the intervention | Personality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism). | just 5 minutes after the intervention |