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Stress, PsychologicalECOSTRESSNCT05136586

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

A study testing Biofeedback and Meditation in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Biofeedback and Meditation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
1 siteFrance
Study dates
7 Dec 2021to 10 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

  • Marc lilot

    Lyon, 69003

Other trials in France

About this study

Official 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

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.

Read the 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.

Being tested
Biofeedback, Meditation, Control and biofeedback post OSCE, Control and control post OSCE
Keywords
Stress management and performance, Medical education
Medical subject headings
Stress, Psychological, Rumination Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiofeedbackOther

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

    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.

  • MeditationOther

    Also called Meditative stimulation audio tape before the circuit, no intervention after

    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.

  • Control and biofeedback post OSCEOther

    Also called Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after

    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

  • Control and control post OSCEOther

    Also called Standardised video before the circuit, no intervention after

    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.

Study groups in NCT05136586
Study groupRoleWhat they receive
BiofeedbackExperimentalRelaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Receives: Other: Biofeedback
MeditationExperimentalMeditative stimulation audio tape before the circuit, no intervention after
Receives: Other: Meditation
Control and biofeedback post OSCEExperimentalStandardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Receives: Other: Control and biofeedback post OSCE
Control and control post OSCESham comparatorStandardised video before the circuit, no intervention after
Receives: Other: Control and control post OSCE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in Performance

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

    Measured: During the first 2 hours of the inclusion

Secondary outcomes (8)

  1. Differences of Physiological stress

    Heart rate variation collected by emWave® devices

    Measured: During the first 2 hours of the inclusion

  2. Differences of Psychological stress

    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

    Measured: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

  3. Difference of Resourcefulness

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

    Measured: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

  4. Characterisation of stress

    Numerical VAS on characterisation of stress perceived from negative to positive

    Measured: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

  5. Differences of Self confidence

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

    Measured: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

  6. Differences of Psychological stress consequences

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

    Measured: Three times : before first intervention, before OSCE circuit, just after second intervention

  7. Differences of Ruminations

    Brief rumination scale questionnaire

    Measured: Just after second intervention at the end of the OSCE

  8. Individual psychological characteristics

    Personality traits (Big-5)

    Measured: Just after second intervention at the end of the OSCE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study start7 Dec 2021
  3. Primary completion9 Dec 2021
  4. Study completion10 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 parallels groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136586
Sponsor's protocol ID
ECOSTRESS
Acronym
ECOSTRESS
Status last verified
Nov 2022
First submitted
4 Nov 2021
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Depoorter J, Hoorelbeke K, Guillaumee T, Cortet M, Lilot M, Rode G, De Raedt R, Schlatter S. Impact of a brief HRV-biofeedback intervention on emotion regulation following a real-life stressful event: A randomized controlled study. Behav Res Ther. 2026 Apr;199:104979. doi: 10.1016/j.brat.2026.104979. Epub 2026 Jan 26.

    PubMed 41702143

  • Le Saux O, Canada B, Debarnot U, Haouhache NEH, Lehot JJ, Binay M, Cortet M, Rimmele T, Duclos A, Rode G, Lilot M, Schlatter S. Association of Personality Traits With the Efficacy of Stress Management Interventions for Medical Students Taking Objective Structured Clinical Examinations. Acad Med. 2024 Jul 1;99(7):784-793. doi: 10.1097/ACM.0000000000005714. Epub 2024 Mar 25.

    PubMed 38534105

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback and Meditation in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Performance (time frame: During the first 2 hours of the inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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