Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Primary Purpose
Exam Stress, Stress, Psychological, Stress, Physiological
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness meditation
Mobilization of inner resources
Biofeedback
Sponsored by
About this trial
This is an interventional prevention trial for Exam Stress
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
Sites / Locations
- Claude Bernard UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Mindfulness
Mobilization of inner resources
Biofeedback
Control
Arm Description
Mindfulness meditation video before the circuit
Standardised video before the circuit
Cardiac biofeedback before the circuit
Standardised video before the circuit
Outcomes
Primary Outcome Measures
Differences of physiological stress
Heart rate variability collected by an ear pulse sensor (emWave® device)
Secondary Outcome Measures
Characterisation of the influence of the intervention on Psychological stress
Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)
Characterisation of the influence of the intervention on Psychological stress
Numerical 100mm-VAS on characterisation of the quality of the perceived stress (from negative stress to positive stress, 50 mm (center) is considered no influence)
Characterisation of the influence of the intervention on level of inner resources
Numerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum)
Characterisation of the influence of the intervention on self-confidence
Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)
Characterisation of intervention on Psychological stress consequences
Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).
Feelings about the intervention
Likert Scale assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun) on a 5 items answers (from not feeling at all, to very importante intensity)
Determining influence of personality traits on the efficiency on the intervention
Personality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05380076
Brief Title
Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Official Title
Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
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
Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students.
Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.
Detailed Description
This randomized, controlled and monocentric study will be conducted during the OSCE tests contributing towards the final exam grades for 4th year medicine students at the Claude Bernard Lyon 1 university.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long.
The randomisation groups are:
Mindfulness through watching/listening video tape
Mobilization of inner resources through watching/listening video tape
Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score
Unemotional video tape as controlled group
Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality.
Main objective is to show that interventions are better than control to reduce stress level before OSCE.
The main outcome is to compare the effect of the interventions on physiological stress, using HRV as physiological stress marker.
Secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. Finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exam Stress, Stress, Psychological, Stress, Physiological
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 parallel groups
Masking
InvestigatorOutcomes Assessor
Masking Description
Interventions are standardized video tape. Information collected through standardized informatic questionnaires for blinded investigators.
Allocation
Randomized
Enrollment
490 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness meditation video before the circuit
Arm Title
Mobilization of inner resources
Arm Type
Experimental
Arm Description
Standardised video before the circuit
Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
Cardiac biofeedback before the circuit
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standardised video before the circuit
Intervention Type
Other
Intervention Name(s)
Mindfulness meditation
Intervention Description
6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.
Intervention Type
Other
Intervention Name(s)
Mobilization of inner resources
Intervention Description
6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit
Intervention Type
Other
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Differences of physiological stress
Description
Heart rate variability collected by an ear pulse sensor (emWave® device)
Time Frame
During the 6min long intervention
Secondary Outcome Measure Information:
Title
Characterisation of the influence of the intervention on Psychological stress
Description
Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)
Time Frame
measured two times: just 30 seconds before and after the intervention
Title
Characterisation of the influence of the intervention on Psychological stress
Description
Numerical 100mm-VAS on characterisation of the quality of the perceived stress (from negative stress to positive stress, 50 mm (center) is considered no influence)
Time Frame
measured two times: just 30 seconds before and after the intervention
Title
Characterisation of the influence of the intervention on level of inner resources
Description
Numerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum)
Time Frame
measured two times: just 30 seconds before and after the intervention
Title
Characterisation of the influence of the intervention on self-confidence
Description
Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)
Time Frame
measured two times: just 30 seconds before and after the intervention
Title
Characterisation of intervention on Psychological stress consequences
Description
Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).
Time Frame
measured two times: just 1 minute before and after the intervention
Title
Feelings about the intervention
Description
Likert Scale assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun) on a 5 items answers (from not feeling at all, to very importante intensity)
Time Frame
just 2 minutes after the intervention
Title
Determining influence of personality traits on the efficiency on the intervention
Description
Personality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism).
Time Frame
just 5 minutes after the 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Lilot, PhD
Phone
+33651806521
Email
marc.lilot@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Schlatter
Email
sophie.schlatter@univ-lyon1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Rode, PhD
Organizational Affiliation
Claude Bernard University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marc Lilot, PhD
Organizational Affiliation
Claude Bernard University
Official's Role
Study Director
Facility Information:
Facility Name
Claude Bernard University
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Lilot
Phone
0651806521
Email
marc.lilot@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sophie Schlatter, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Protocol will be available on request
Learn more about this trial
Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
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