Cardiac Biofeedback, Mindfulness, and Inner Resources Mobilization Interventions on Performances of Medical Students

NCT ID: NCT05393219

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2023-06-20

Brief 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.

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.

Conditions

Stress, Psychological; Stress; Stress, Physiological; Exam Stress; Performance; Mindfulness; Communication; Medical Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cardiac Biofeedback

Relaxing breathing exercise coupled with cardiac biofeedback

Group Type: EXPERIMENTAL

Cardiac biofeedback

Intervention Type: OTHER

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

Mindfulness

Mindfulness guided through a video tape

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: OTHER

6 minutes of a guided video tape made for the study that inspires mindfulness like meditation associated just before entering the examination circuit.

Inner resource mobilization

Resources and inner strength mobilization guided through a video tape

Group Type: EXPERIMENTAL

Resources mobilization

Intervention Type: OTHER

6 minutes of a guided video tape that purpose to mobilize inner resources and strength of the student just before entering the examination circuit.

Control

Standardized video tape

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit.

Interventions

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

Intervention Type: OTHER

Mindfulness

6 minutes of a guided video tape made for the study that inspires mindfulness like meditation associated just before entering the examination circuit.

Intervention Type: OTHER

Resources 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.

Intervention Type: OTHER

Control

6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit.

Intervention Type: OTHER

Other Intervention Names

Relaxing breathing exercise coupled with cardiac biofeedback; Mindfulness meditation; Resources and inner strength mobilization; Standardized video

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Claude Bernard University

OTHER

Sponsor Role: lead

Responsible Party

Lilot Marc

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilles Rode, Ph. D.

Role: STUDY_CHAIR

Claude Bernard University

Marc Lilot, Ph. D.

Role: STUDY_DIRECTOR

Claude Bernard University

Locations

Claude Bernard University

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39752249 (View on PubMed)

Other Identifiers

Performance and OSCE

Identifier Type: -

Identifier Source: org_study_id