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

Claude Bernard University

Status: Completed

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

Treatments: Other: Control and biofeedback post OSCE; Other: Biofeedback; Other: Control and control post OSCE; Other: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05136586

ECOSTRESS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 4 patient groups

Biofeedback

Experimental group

Description:

Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after

Treatment:

Other: Biofeedback

Meditation

Experimental group

Description:

Meditative stimulation audio tape before the circuit, no intervention after

Treatment:

Other: Meditation

Control and biofeedback post OSCE

Experimental group

Description:

Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE

Treatment:

Other: Control and biofeedback post OSCE

Control and control post OSCE

Sham Comparator group

Description:

Standardised video before the circuit, no intervention after

Treatment:

Other: Control and control post OSCE