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

Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393219
• Other study ID #: Performance and OSCE
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: August 2023
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: June 20, 2023
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult person

• Registered as medical student at the university

• Participating at OSCE examination

• Have signed an informed consent form.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Communication
• Medical Education
• Mindfulness
• Performance
• Stress
• Stress, Physiological
• Stress, Psychological

Intervention

Other:
• 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
• Mindfulness
6 minutes of a guided video tape made for the study that inspires mindfulness like meditation associated just before entering the examination circuit.
• 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.
• Control
6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit.

Locations

Country	Name	City	State
France	Claude Bernard University	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	rated during the exam, calculated during the first 2 weeks after the exam
Secondary	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).	rated during the OSCE, calculated during the first 2 weeks after the OSCE
Secondary	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)	rated during the exam, calculated during the first 2 weeks after the exam
Secondary	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.	Once - in the 2 minutes after the OSCE station
Secondary	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).	during the first 5 minutes just after OSCE
Secondary	Mean Difference of Inner Resource	Numerical VAS on inner resource available perceived (from 0 to 100 : maximum)	Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Secondary	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)	Just 5 minutes after the OSCE
Secondary	Mean Differences of Self confidence	Numerical VAS on self-confidence perceived from zero to 100: maximum	Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)