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

Not Applicable
Completed
Conditions
Stress, Physiological
Exam Stress
Stress, Psychological
Performance Anxiety
Rumination
Interventions
Other: Control and control post OSCE
Other: Control and biofeedback post OSCE
Other: Biofeedback
Other: Meditation
Registration Number
NCT05136586
Lead Sponsor
Claude Bernard University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
450
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control and control post OSCEControl and control post OSCEStandardised video before the circuit, no intervention after
Control and biofeedback post OSCEControl and biofeedback post OSCEStandardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
BiofeedbackBiofeedbackRelaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
MeditationMeditationMeditative stimulation audio tape before the circuit, no intervention after
Primary Outcome Measures
NameTimeMethod
Differences in PerformanceDuring the first 2 hours of the inclusion

The performance is student grade at the exam, as determined by university evaluator

Secondary Outcome Measures
NameTimeMethod
Differences of Physiological stressDuring the first 2 hours of the inclusion

Heart rate variation collected by emWave® devices

Characterisation of stressFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

Numerical VAS on characterisation of stress perceived from negative to positive

Differences of Self confidenceFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

Numerical VAS on self confidence perceived from zero to 100: maximum

Differences of Psychological stress consequencesThree times : before first intervention, before OSCE circuit, just after second intervention

Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness

Differences of RuminationsJust after second intervention at the end of the OSCE

Brief rumination scale questionnaire

Differences of Psychological stressFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

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

Difference of ResourcefulnessFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum

Individual psychological characteristicsJust after second intervention at the end of the OSCE

Personality traits (Big-5)

Trial Locations

Locations (1)

Marc lilot

🇫🇷

Lyon, France

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