Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students

NCT05136586 | Completed

• 1 other identifier: ECOSTRESS
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical student and is a determinant part of the national competition they have to undergo. Medical studies, especially during examen period, are significantly associated with risk of developping depressions or anxious trouble, wich led to lesser performance, impaired memorization and impaired workload capacities. Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback and meditation are procedures used to reduce the stress level. There is currently no study on the effect of stress management procedures on the performance during OSCE for medical student.

Conditions

Stress, Psychological; Stress, Physiological; Exam Stress; Performance Anxiety; Rumination

Keywords

Stress management and performance; Medical education

Outcome Measures

Primary Outcomes (1)

• Differences in Performance

  The performance is student grade at the exam, as determined by university evaluator

  During the first 2 hours of the inclusion

Secondary Outcomes (8)

• Differences of Physiological stress

  During the first 2 hours of the inclusion

• Differences of Psychological stress

  Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

• Difference of Resourcefulness

  Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

• Characterisation of stress

  Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

• Differences of Self confidence

  Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention

Study Arms (4)

Biofeedback

EXPERIMENTAL

Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after

Other: Biofeedback

Meditation

EXPERIMENTAL

Meditative stimulation audio tape before the circuit, no intervention after

Other: Meditation

Control and biofeedback post OSCE

EXPERIMENTAL

Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE

Other: Control and biofeedback post OSCE

Control and control post OSCE

SHAM COMPARATOR

Standardised video before the circuit, no intervention after

Other: Control and control post OSCE

Interventions

Biofeedback OTHER

6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instruction.

Also known as: Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after

Biofeedback

Meditation OTHER

6 minutes of listening an audio tape made for the study that inspire mindfulness like meditation associated with psychological stimulation (positive encouragement) just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instructions.

Also known as: Meditative stimulation audio tape before the circuit, no intervention after

Meditation

Control and biofeedback post OSCE OTHER

6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer

Also known as: Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after

Control and biofeedback post OSCE

Control and control post OSCE OTHER

6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of of free activity where the participants will not be given any instruction.

Also known as: Standardised video before the circuit, no intervention after

Control and control post OSCE

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)

Marc lilot

Lyon, 69003, France

Location

Related Publications (1)

• Le Saux O, Canada B, Debarnot U, Haouhache NEH, Lehot JJ, Binay M, Cortet M, Rimmele T, Duclos A, Rode G, Lilot M, Schlatter S. Association of Personality Traits With the Efficacy of Stress Management Interventions for Medical Students Taking Objective Structured Clinical Examinations. Acad Med. 2024 Jul 1;99(7):784-793. doi: 10.1097/ACM.0000000000005714. Epub 2024 Mar 25.

  PMID: 38534105 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Rumination Syndrome

Interventions

Biofeedback, Psychology; Meditation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Spiritual Therapies; Relaxation Therapy

Study Officials

• Gilles Rode, M.D., Ph.D.

  Claude Bernard University

  STUDY CHAIR

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: Principal Investigator

Model Details: 4 parallels groups

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 29, 2021
• Study Start: December 7, 2021
• Primary Completion: December 9, 2021
• Study Completion: June 10, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

FR (1)