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

Claude Bernard University

Status: Completed

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

Treatments: Other: Resources mobilization; Other: Mindfulness; Other: Cardiac biofeedback; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05393219

Performance and OSCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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490 participants in 4 patient groups

Cardiac Biofeedback

Experimental group

Description:

Relaxing breathing exercise coupled with cardiac biofeedback

Treatment:

Other: Cardiac biofeedback

Mindfulness

Experimental group

Description:

Mindfulness guided through a video tape

Treatment:

Other: Mindfulness

Inner resource mobilization

Experimental group

Description:

Resources and inner strength mobilization guided through a video tape

Treatment:

Other: Resources mobilization

Control

Sham Comparator group

Description:

Standardized video tape

Treatment:

Other: Control