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

Primary Purpose

Stress, Psychological, Stress, Physiological, Exam Stress

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biofeedback
Meditation
Control and biofeedback post OSCE
Control and control post OSCE
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological focused on measuring Stress management and performance, Medical education

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

  • Marc lilot

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Biofeedback

Meditation

Control and biofeedback post OSCE

Control and control post OSCE

Arm Description

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

Meditative stimulation audio tape before the circuit, no intervention after

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

Standardised video before the circuit, no intervention after

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differences of Physiological stress
Heart rate variation collected by emWave® devices
Differences of Psychological stress
Numerical Visual analog scales (VAS) on perceived stress from zero to 100: maximum Numerical VAS on resourcefulness nedeed an avalaible perceived from zero to maximum
Difference of Resourcefulness
Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
Characterisation of stress
Numerical VAS on characterisation of stress perceived from negative to positive
Differences of Self confidence
Numerical VAS on self confidence perceived from zero to 100: maximum
Differences of Psychological stress consequences
Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Differences of Ruminations
Brief rumination scale questionnaire
Individual psychological characteristics
Personality traits (Big-5)

Full Information

First Posted
November 4, 2021
Last Updated
November 6, 2022
Sponsor
Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT05136586
Brief Title
Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students
Acronym
ECOSTRESS
Official Title
Effects of Two Stress Management Procedures on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students : Relaxing Breathing Combined With Biofeedback or Meditative Stimulation : ECOSTRESS Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
June 10, 2022 (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 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.
Detailed Description
This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical student. For examination purpose, the students will be divided in four groups that will undergo identical exam in the same time in four parallels circuits. Before entering the circuit, all the students will received information for the study and sign consent. All the students will be equipped with emWAve® devices that allows us to collect heart rate variability as physiological stress marker during the time of the intervention. Participants will undergo short questionnaires regarding perceived stress. Then the groups of students will be randomized in four interventions groups for receiving a combination of intervention before and/or after the examination circuit. All the interventions last six minutes long. The randomisation groups are : Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after Meditative stimulation audio tape before the circuit, no intervention after Standardised video as controlled group before the circuit and a relaxing breathing exercise coupled with biofeedback after Standardised video as controlled group before and not intervention after At the end of the examination circuit, all the students will undergo short questionnaires regarding stress, participants will get equipped with emWAve ® devices again and participants will get the second intervention depending on the randomisation group. Main objective is to show that relaxing breathing exercise coupled with biofeedback or meditative stimulation is better than an standardised video on performance during OSCE. The main outcome is student grade at the exam, as determined by university evaluator who is blind to the intervention and with no links to the study. Secondary objectives are to compare the effects of the interventions on measured physiological stress, psychological stress, and negative rumination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Exam Stress, Performance Anxiety, Rumination
Keywords
Stress management and performance, 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
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Arm Title
Meditation
Arm Type
Experimental
Arm Description
Meditative stimulation audio tape before the circuit, no intervention after
Arm Title
Control and biofeedback post OSCE
Arm Type
Experimental
Arm Description
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Arm Title
Control and control post OSCE
Arm Type
Sham Comparator
Arm Description
Standardised video before the circuit, no intervention after
Intervention Type
Other
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Meditation
Other Intervention Name(s)
Meditative stimulation audio tape before the circuit, no intervention after
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control and biofeedback post OSCE
Other Intervention Name(s)
Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control and control post OSCE
Other Intervention Name(s)
Standardised video before the circuit, no intervention after
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in Performance
Description
The performance is student grade at the exam, as determined by university evaluator
Time Frame
During the first 2 hours of the inclusion
Secondary Outcome Measure Information:
Title
Differences of Physiological stress
Description
Heart rate variation collected by emWave® devices
Time Frame
During the first 2 hours of the inclusion
Title
Differences of Psychological stress
Description
Numerical Visual analog scales (VAS) on perceived stress from zero to 100: maximum Numerical VAS on resourcefulness nedeed an avalaible perceived from zero to maximum
Time Frame
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Title
Difference of Resourcefulness
Description
Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
Time Frame
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Title
Characterisation of stress
Description
Numerical VAS on characterisation of stress perceived from negative to positive
Time Frame
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Title
Differences of Self confidence
Description
Numerical VAS on self confidence perceived from zero to 100: maximum
Time Frame
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Title
Differences of Psychological stress consequences
Description
Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Time Frame
Three times : before first intervention, before OSCE circuit, just after second intervention
Title
Differences of Ruminations
Description
Brief rumination scale questionnaire
Time Frame
Just after second intervention at the end of the OSCE
Title
Individual psychological characteristics
Description
Personality traits (Big-5)
Time Frame
Just after second intervention at the end of the OSCE

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, M.D., Ph.D.
Organizational Affiliation
Claude Bernard University
Official's Role
Study Chair
Facility Information:
Facility Name
Marc lilot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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

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