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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05136586
Acronym
ECOSTRESS
Enrollment
450
Registered
2021-11-29
Start date
2021-12-07
Completion date
2022-06-10
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stress management and performance, Medical education

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.

Interventions

OTHERBiofeedback

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.

OTHERMeditation

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.

OTHERControl 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

OTHERControl 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.

Sponsors

Claude Bernard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Performance is evaluated by assessors who are blind to the intervention

Intervention model description

4 parallels groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Differences in PerformanceDuring the first 2 hours of the inclusionThe performance is student grade at the exam, as determined by university evaluator

Secondary

MeasureTime frameDescription
Differences of Psychological stressFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second interventionNumerical 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 interventionNumerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
Characterisation of stressFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second interventionNumerical VAS on characterisation of stress perceived from negative to positive
Differences of Physiological stressDuring the first 2 hours of the inclusionHeart rate variation collected by emWave® devices
Differences of Psychological stress consequencesThree times : before first intervention, before OSCE circuit, just after second interventionActivation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Differences of RuminationsJust after second intervention at the end of the OSCEBrief rumination scale questionnaire
Individual psychological characteristicsJust after second intervention at the end of the OSCEPersonality traits (Big-5)
Differences of Self confidenceFour times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second interventionNumerical VAS on self confidence perceived from zero to 100: maximum

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026