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Completed

NCT Number: NCT05136586

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

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Digestive System Diseases Exam Stress Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Performance Anxiety Rumination Rumination Syndrome Stress, Physiological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marc lilot

Lyon, 69003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Biofeedback

Other

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.

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

Meditation

Other

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.

Other names: Meditative stimulation audio tape before the circuit, no intervention after

Control and biofeedback post OSCE

Other

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

Other names: Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after

Control and control post OSCE

Other

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.

Other names: Standardised video before the circuit, no intervention after

Primary outcomes

  1. Differences in Performance

    Time frame: During the first 2 hours of the inclusion

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

Secondary outcomes

  1. Differences of Physiological stress

    Time frame: During the first 2 hours of the inclusion

    Heart rate variation collected by emWave® devices

  2. Differences of Psychological stress

    Time frame: Four 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

  3. Difference of Resourcefulness

    Time frame: Four 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

  4. Characterisation of stress

    Time frame: Four 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

  5. Differences of Self confidence

    Time frame: Four 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

  6. Differences of Psychological stress consequences

    Time frame: Three 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

  7. Differences of Ruminations

    Time frame: Just after second intervention at the end of the OSCE

    Brief rumination scale questionnaire

  8. Individual psychological characteristics

    Time frame: Just after second intervention at the end of the OSCE

    Personality traits (Big-5)

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Acronym: ECOSTRESS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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