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

NCT05393219 | Completed

• 1 other identifier: Performance and OSCE
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean Differences in Subjective Performance

  rated during the OSCE, calculated during the first 2 weeks after the OSCE

• Mean Differences in Three Objective Performance sub-scores

  rated during the exam, calculated during the first 2 weeks after the exam

• Mean Differences in Hetero-Evaluated Emotional Performance

  Once - in the 2 minutes after the OSCE station

• Mean Differences in Auto-evaluated Emotional Performance

  during the first 5 minutes just after OSCE

• Mean Difference of Inner Resource

  Two times : 10min before OSCE (before intervention) and just 2 minutes before the OSCE (after intervention)

Study Arms (4)

Cardiac Biofeedback

EXPERIMENTAL

Relaxing breathing exercise coupled with cardiac biofeedback

Other: Cardiac biofeedback

Mindfulness

EXPERIMENTAL

Mindfulness guided through a video tape

Other: Mindfulness

Inner resource mobilization

EXPERIMENTAL

Resources and inner strength mobilization guided through a video tape

Other: Resources mobilization

Control

SHAM COMPARATOR

Standardized video tape

Other: Control

Interventions

Cardiac biofeedback 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

Also known as: Relaxing breathing exercise coupled with cardiac biofeedback

Cardiac Biofeedback

Mindfulness OTHER

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

Also known as: Mindfulness meditation

Mindfulness

Resources mobilization 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.

Also known as: Resources and inner strength mobilization

Inner resource mobilization

Control OTHER

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

Also known as: Standardized video

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Claude Bernard University: lead

Study Sites (1)

Claude Bernard University

Lyon, France

Location

Related Publications (1)

• 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.

  PMID: 39752249 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Communication

Interventions

Mindfulness; Health Resources

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Gilles Rode, Ph. D.

  Claude Bernard University

  STUDY CHAIR

• Marc Lilot, Ph. D.

  Claude Bernard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Performance is evaluated by assessors who are blind to the intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 4 parallels groups

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 26, 2022
• Study Start: May 17, 2022
• Primary Completion: July 19, 2022
• Study Completion: June 20, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

FR (1)