Clinical trial NCT05393219: Cardiac Biofeedback, Mindfulness, and Inner Resources Mobilization Interventions on Performances of Medical Students
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress
Stress, Physiological
Exam Stress
Performance
Mindfulness
Communication
Medical Education
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 parallels groups
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mean of quantitative performance score for all the exam
timeFrame: rated during the exam, calculated during the first 2 weeks after the exam
Secondary outcomes:
measure: Mean Differences in Subjective Performance
timeFrame: rated during the OSCE, calculated during the first 2 weeks after the OSCE
measure: Mean Differences in Three Objective Performance sub-scores
timeFrame: rated during the exam, calculated during the first 2 weeks after the exam
measure: Mean Differences in Hetero-Evaluated Emotional Performance
timeFrame: Once - in the 2 minutes after the OSCE station
measure: Mean Differences in Auto-evaluated Emotional Performance
timeFrame: during the first 5 minutes just after OSCE
measure: Mean Difference of Inner Resource
timeFrame: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
measure: Mean difference of perceived impact of the intervention on performance
timeFrame: Just 5 minutes after the OSCE
measure: Mean Differences of Self confidence
timeFrame: Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Claude Bernard University
Study officials:
affiliation: Claude Bernard University
name: Gilles Rode, Ph. D.
role: STUDY_CHAIR
affiliation: Claude Bernard University
name: Marc Lilot, Ph. D.
role: STUDY_DIRECTOR
References: