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

Primary Purpose

Stress, Psychological, Stress, Stress, Physiological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac biofeedback
Mindfulness
Resources mobilization
Control
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Claude Bernard University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Cardiac Biofeedback

Mindfulness

Inner resource mobilization

Control

Arm Description

Relaxing breathing exercise coupled with cardiac biofeedback

Mindfulness guided through a video tape

Resources and inner strength mobilization guided through a video tape

Standardized video tape

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)
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.
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).
Mean Difference of Inner Resource
Numerical VAS on inner resource available perceived (from 0 to 100 : maximum)
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)
Mean Differences of Self confidence
Numerical VAS on self-confidence perceived from zero to 100: maximum

Full Information

First Posted
May 15, 2022
Last Updated
August 26, 2023
Sponsor
Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT05393219
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Stress, Physiological, Exam Stress, Performance, Mindfulness, Communication, Medical Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 parallels groups
Masking
InvestigatorOutcomes Assessor
Masking Description
Performance is evaluated by assessors who are blind to the intervention
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Biofeedback
Arm Type
Experimental
Arm Description
Relaxing breathing exercise coupled with cardiac biofeedback
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness guided through a video tape
Arm Title
Inner resource mobilization
Arm Type
Experimental
Arm Description
Resources and inner strength mobilization guided through a video tape
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standardized video tape
Intervention Type
Other
Intervention Name(s)
Cardiac biofeedback
Other Intervention Name(s)
Relaxing breathing exercise coupled with cardiac biofeedback
Intervention Description
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
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
Mindfulness meditation
Intervention Description
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
Intervention Name(s)
Resources mobilization
Other Intervention Name(s)
Resources and inner strength mobilization
Intervention Description
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
Intervention Name(s)
Control
Other Intervention Name(s)
Standardized video
Intervention Description
6 minutes of standardized neutral video on general topics that generates no modification of affects just before entering the examination circuit.
Primary Outcome Measure Information:
Title
Mean of quantitative performance score for all the exam
Description
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.
Time Frame
rated during the exam, calculated during the first 2 weeks after the exam
Secondary Outcome Measure Information:
Title
Mean Differences in Subjective Performance
Description
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).
Time Frame
rated during the OSCE, calculated during the first 2 weeks after the OSCE
Title
Mean Differences in Three Objective Performance sub-scores
Description
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)
Time Frame
rated during the exam, calculated during the first 2 weeks after the exam
Title
Mean Differences in Hetero-Evaluated Emotional Performance
Description
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.
Time Frame
Once - in the 2 minutes after the OSCE station
Title
Mean Differences in Auto-evaluated Emotional Performance
Description
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).
Time Frame
during the first 5 minutes just after OSCE
Title
Mean Difference of Inner Resource
Description
Numerical VAS on inner resource available perceived (from 0 to 100 : maximum)
Time Frame
Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)
Title
Mean difference of perceived impact of the intervention on performance
Description
Numerical Visual analog scales (VAS) on perceived impact of the intervention on performance (from zero: negative to 100: positive)
Time Frame
Just 5 minutes after the OSCE
Title
Mean Differences of Self confidence
Description
Numerical VAS on self-confidence perceived from zero to 100: maximum
Time Frame
Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Rode, Ph. D.
Organizational Affiliation
Claude Bernard University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marc Lilot, Ph. D.
Organizational Affiliation
Claude Bernard University
Official's Role
Study Director
Facility Information:
Facility Name
Claude Bernard University
City
Lyon
Country
France

12. IPD Sharing Statement

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

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