Stress, PsychologicalNCT05393219
Cardiac Biofeedback, Mindfulness, and Inner Resources Mobilization Interventions on Performances of Medical Students
A study testing Cardiac biofeedback, Mindfulness and Resources mobilization in people with Stress, Psychological and Stress, run by Claude Bernard University at 1 site in France.
Trial summary
Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical students 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
- Conditions the study is for
- Stress, Psychological, Stress, Stress, Physiological
- What is being tested?
- Cardiac biofeedback, Mindfulness and Resources mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2022to 20 Jun 2023
- 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.
About this study
Official title: Effects of Preventive Physiological and Psychological Interventions on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students: Cardiac Biofeedback, Mindfulness, or Inner Resources Mobilization
Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical students and is a determinant part of the national competition they have to undergo.
Exam periods are significantly associated with increased stress and anxiety which led to reduced performance, impaired memorization and impaired workload capacities.
Read more
Cardiac biofeedback and mindfulness techniques are efficient methods for stress reduction. Interventions that aim to mobilize competence, such as mobilization of inner strength and resources techniques, should improve the level of preparation of medical students. These three procedures could influence the stress level and improve performance during the OSCE.
There is currently no study exploring the effect of these physiological and psychological procedures on the performance during OSCE for medical students.
Read the detailed description
This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical students. For examination purposes, the students will be divided into four groups that will undergo identical exams at the same time in four parallel circuits.
Before entering the station of OSCE and before being involved in the research, all the students will receive information about the study and sign a consent form.
Participants will undergo short questionnaires regarding inner resources available to accomplish the exam and questionnaire exploring self-confidence.
Then the groups of students will be randomized in four intervention groups before the examination circuit. All the interventions will last six minutes long. The randomization groups are:
- Cardiac biofeedback (guided through a video with a breathing cursus and visual cardiac feedback)
- Mindfulness (guided through a video)
- Resources and Inner Strength Mobilization (guided through a video)
- Control group (guided through a neutral-content video)
At the end of the intervention, all the students will undergo short questionnaires regarding their perceived level of resources to accomplish the exam and their self-confidence.
During the OSCE, examiner will evaluate the performance of the students. All the examiner will be blind to the student's experimental group.
After the OSCE circuit, students will be asked to rate their perceived emotional performance during the exam (Likert scale). They have to answer a visual analogue scale, to declare how they estimate that the intervention has influenced their performance (from negative to positive).
The final score of the student, as determined by the examiner, will be composed of:
- Objective quantitative score with respect to the specific evaluation grid for each OSCE scenario.
- Subjective qualitative score (Likert scale)
Emotional Performance will be assessed by two means:
- Emotional performance score hetero-evaluated by the examiner (Likert scale)
- Emotional performance score auto-evaluated by the student (Likert scale) Main objective is to show that a preventive physiological and psychological intervention (cardiac biofeedback, or mindfulness, or Inner resource mobilization) is better than a neutral-content video on the following performance during OSCE.
The main outcome is the mean score of student objective quantitative score (composed by the mean of each quantitative score of the five stations during the OSCE) at as determined by the university examiner.
Secondary objectives are to compare the effects of the interventions on all the components of the performance score: objective quantitative score, subjective qualitative score, emotional performance score hetero and auto-evaluated. Three sub-scores of the objective quantitative score (divided into communication (C), knowledge (K) and Skills (S) performance) will be compared. Visual analogue scales of perceived inner resource available to pass the exam, self-confidence and perceived effect of the intervention on the performance will also be compared.
- Conditions
- Stress, Psychological, Stress, Stress, Physiological, Exam Stress, Performance, Mindfulness
- Being tested
- Cardiac biofeedback, Mindfulness, Resources mobilization, Control
- Medical subject headings
- Stress, Psychological, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac biofeedbackOther
Also called Relaxing breathing exercise coupled with cardiac biofeedback
6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on emWave Pro software on a computer just before entering the examination circuit
MindfulnessOther
Also called Mindfulness meditation
6 minutes of a guided video tape made for the study that inspires mindfulness like meditation associated just before entering the examination circuit.
Resources mobilizationOther
Also called Resources and inner strength mobilization
6 minutes of a guided video tape that purpose to mobilize inner resources and strength of the student just before entering the examination circuit.
ControlOther
Also called Standardized video
6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Biofeedback | Experimental | Relaxing breathing exercise coupled with cardiac biofeedback Receives: Other: Cardiac biofeedback |
| Mindfulness | Experimental | Mindfulness guided through a video tape Receives: Other: Mindfulness |
| Inner resource mobilization | Experimental | Resources and inner strength mobilization guided through a video tape Receives: Other: Resources mobilization |
| Control | Sham comparator | Standardized video tape Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of quantitative performance score for all the exam
Mean of quantitative performance score for all the exam (mean of the five performance score for the 5 stations of the exam (from zero to maximum: 40). Each objective performance score of a station is determined by a specific scenario grid performance.) The primary outcome will be determined by university examiners who are independent of the study and blinded to the interventions.
Measured: rated during the exam, calculated during the first 2 weeks after the exam
Secondary outcomes (7)
Mean Differences in Subjective Performance
The subjective qualitative performance is the score qualitative of overall performance of each student as determined by university examiners who are independent of the study and blind to the intervention (mean of 5 scores). Each score of subjective performance will be determine on a Likert scale (from 0 to 5).
Measured: rated during the OSCE, calculated during the first 2 weeks after the OSCE
Mean Differences in Three Objective Performance sub-scores
Each scenario has a specific grid composed of numerous items. Each item of all the scenario grid will be sorted by regarding if they evaluate communication ability (C), knowledge (K), or skills ability (S).
The sorting of the items between the three groups (C, K and S) will be assessed by two experts independently. In case of a disagreement, a third expert will be asked to choose. Every student will get a score regarding these three sub-scores (from 0 to maximum: 40)
Measured: rated during the exam, calculated during the first 2 weeks after the exam
Mean Differences in Hetero-Evaluated Emotional Performance
The emotional performance rated by examiners is the overall appreciation of the student ability to control his/her emotion during each station (e.g., control stress, communicate with empathy…). For each OSCE station, the student emotional performance will be evaluated on a Likert scale (0 to 5) by the examiner.
Measured: Once - in the 2 minutes after the OSCE station
Mean Differences in Auto-evaluated Emotional Performance
The emotional performance rated by the student himself is the overall appreciation of the student demonstrated ability during the whole OSCE (the five stations) to control his/her emotion (e.g., control stress, communicate with empathy…). Each student will evaluated his/her performance on a Likert scale (0 to 5).
Measured: during the first 5 minutes just after OSCE
Mean Difference of Inner Resource
Numerical VAS on inner resource available perceived (from 0 to 100 : maximum)
Measured: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Mean difference of perceived impact of the intervention on performance
Numerical Visual analog scales (VAS) on perceived impact of the intervention on performance (from zero: negative to 100: positive)
Measured: Just 5 minutes after the OSCE
Mean Differences of Self confidence
Numerical VAS on self-confidence perceived from zero to 100: maximum
Measured: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start17 May 2022
- Primary completion19 Jul 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Gilles Rode, Ph. D., Study chair, Claude Bernard UniversityMarc Lilot, Ph. D., Study director, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393219
- Sponsor's protocol ID
- Performance and OSCE
- Status last verified
- Aug 2023
- First submitted
- 15 May 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schlatter S, Berland A, Lutz A, Shankland R, Barret N, Guillaumee T, Duclos A, Cortet M, Rimmele T, Rode G, Lilot M. Effect of coping interventions on performance of medical students during objective structured clinical examination: A randomized controlled trial. Med Teach. 2025 Aug;47(8):1367-1376. doi: 10.1080/0142159X.2024.2431137. Epub 2025 Jan 3.
PubMed 39752249
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preventive Physiological and Psychological Interventions on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students: Cardiac Biofeedback, Mindfulness, or Inner Resources Mobilization
- ClinicalTrials.gov ID
- NCT05393219
- Acronym / sponsor ID
- Performance and OSCE
- Conditions
- Stress, Psychological, Stress, Stress, Physiological, Exam Stress, Performance, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical students and is a determinant part of the national competition they have to undergo.
Exam periods are significantly associated with increased stress and anxiety which led to reduced performance, impaired memorization and impaired workload capacities.
Cardiac biofeedback and mindfulness techniques are efficient methods for stress reduction. Interventions that aim to mobilize competence, such as mobilization of inner strength and resources techniques, should improve the level of preparation of medical students. These three procedures could influence the stress level and improve performance during the OSCE.
There is currently no study exploring the effect of these physiological and psychological procedures on the performance during OSCE for medical students.
Detailed description
This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical students. For examination purposes, the students will be divided into four groups that will undergo identical exams at the same time in four parallel circuits.
Before entering the station of OSCE and before being involved in the research, all the students will receive information about the study and sign a consent form.
Participants will undergo short questionnaires regarding inner resources available to accomplish the exam and questionnaire exploring self-confidence.
Then the groups of students will be randomized in four intervention groups before the examination circuit. All the interventions will last six minutes long. The randomization groups are:
- Cardiac biofeedback (guided through a video with a breathing cursus and visual cardiac feedback)
- Mindfulness (guided through a video)
- Resources and Inner Strength Mobilization (guided through a video)
- Control group (guided through a neutral-content video)
At the end of the intervention, all the students will undergo short questionnaires regarding their perceived level of resources to accomplish the exam and their self-confidence.
During the OSCE, examiner will evaluate the performance of the students. All the examiner will be blind to the student's experimental group.
After the OSCE circuit, students will be asked to rate their perceived emotional performance during the exam (Likert scale). They have to answer a visual analogue scale, to declare how they estimate that the intervention has influenced their performance (from negative to positive).
The final score of the student, as determined by the examiner, will be composed of:
- Objective quantitative score with respect to the specific evaluation grid for each OSCE scenario.
- Subjective qualitative score (Likert scale)
Emotional Performance will be assessed by two means:
- Emotional performance score hetero-evaluated by the examiner (Likert scale)
- Emotional performance score auto-evaluated by the student (Likert scale) Main objective is to show that a preventive physiological and psychological intervention (cardiac biofeedback, or mindfulness, or Inner resource mobilization) is better than a neutral-content video on the following performance during OSCE.
The main outcome is the mean score of student objective quantitative score (composed by the mean of each quantitative score of the five stations during the OSCE) at as determined by the university examiner.
Secondary objectives are to compare the effects of the interventions on all the components of the performance score: objective quantitative score, subjective qualitative score, emotional performance score hetero and auto-evaluated. Three sub-scores of the objective quantitative score (divided into communication (C), knowledge (K) and Skills (S) performance) will be compared. Visual analogue scales of perceived inner resource available to pass the exam, self-confidence and perceived effect of the intervention on the performance will also be compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 parallels groups
| Arm | Type | Receives |
|---|---|---|
| Cardiac Biofeedback | Experimental | Other: Cardiac biofeedbackRelaxing breathing exercise coupled with cardiac biofeedback |
| Mindfulness | Experimental | Other: MindfulnessMindfulness guided through a video tape |
| Inner resource mobilization | Experimental | Other: Resources mobilizationResources and inner strength mobilization guided through a video tape |
| Control | Sham comparator | Other: ControlStandardized video tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult person
- Registered as medical student at the university
- Participating at OSCE examination
- Have signed an informed consent form.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac biofeedbackAlso: Relaxing breathing exercise coupled with cardiac biofeedback6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on emWave Pro software on a computer just before entering the examination circuit | Other | Cardiac Biofeedback |
| MindfulnessAlso: Mindfulness meditation6 minutes of a guided video tape made for the study that inspires mindfulness like meditation associated just before entering the examination circuit. | Other | Mindfulness |
| Resources mobilizationAlso: Resources and inner strength mobilization6 minutes of a guided video tape that purpose to mobilize inner resources and strength of the student just before entering the examination circuit. | Other | Inner resource mobilization |
| ControlAlso: Standardized video6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit. | Other | Control |
Primary outcome
Mean of quantitative performance score for all the exam
Time frame: rated during the exam, calculated during the first 2 weeks after the exam
Mean of quantitative performance score for all the exam (mean of the five performance score for the 5 stations of the exam (from zero to maximum: 40). Each objective performance score of a station is determined by a specific scenario grid performance.) The primary outcome will be determined by university examiners who are independent of the study and blinded to the interventions.
7 secondary outcomes
Mean Differences in Subjective Performance
Time frame: rated during the OSCE, calculated during the first 2 weeks after the OSCE
Mean Differences in Three Objective Performance sub-scores
Time frame: rated during the exam, calculated during the first 2 weeks after the exam
Mean Differences in Hetero-Evaluated Emotional Performance
Time frame: Once - in the 2 minutes after the OSCE station
Mean Differences in Auto-evaluated Emotional Performance
Time frame: during the first 5 minutes just after OSCE
Mean Difference of Inner Resource
Time frame: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Mean difference of perceived impact of the intervention on performance
Time frame: Just 5 minutes after the OSCE
Mean Differences of Self confidence
Time frame: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 39752249Schlatter S, Berland A, Lutz A, Shankland R, Barret N, Guillaumee T, Duclos A, Cortet M, Rimmele T, Rode G, Lilot M. Effect of coping interventions on performance of medical students during objective structured clinical examination: A randomized controlled trial. Med Teach. 2025 Aug;47(8):1367-1376. doi: 10.1080/0142159X.2024.2431137. Epub 2025 Jan 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Rode, Ph. D. study chair
Claude Bernard University
Marc Lilot, Ph. D. study director
Claude Bernard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac biofeedback, Mindfulness and Resources mobilization in people with Stress, Psychological and Stress, 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 29 Aug 2023. 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?
Mean of quantitative performance score for all the exam (time frame: rated during the exam, calculated during the first 2 weeks after the exam). 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 NCT05393219, which also lists 1 linked publication.
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 29 Aug 2023.