Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students

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.

Study Overview

• Status: Recruiting
• Conditions: Stress, Psychological; Stress, Physiological; Exam Stress
• Intervention / Treatment: Other: Mindfulness meditation; Other: Mobilization of inner resources; Other: Biofeedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 490
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Lilot, PhD; Phone Number: +33651806521; Email: marc.lilot@chu-lyon.fr
• Study Contact Backup: Name: Sophie Schlatter; Email: sophie.schlatter@univ-lyon1.fr

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Claude Bernard University
    • Contact: Marc Lilot; Phone Number: 0651806521; Email: marc.lilot@chu-lyon.fr
    • Sub-Investigator: Sophie Schlatter, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Mindfulness meditation video before the circuit	Other: Mindfulness meditation; 6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.
Experimental: Mobilization of inner resources; Standardised video before the circuit	Other: Mobilization of inner resources; 6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit
Experimental: Biofeedback; Cardiac biofeedback before the circuit	Other: Biofeedback; 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.
Sham Comparator: Control; Standardised video before the circuit	Other: Mindfulness meditation; 6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.; Other: Mobilization of inner resources; 6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit; Other: Biofeedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of physiological stress	Heart rate variability collected by an ear pulse sensor (emWave® device)	During the 6min long intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterisation of the influence of the intervention on Psychological stress	Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)	measured two times: just 30 seconds before and after the intervention
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)	measured two times: just 30 seconds before and after the intervention
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)	measured two times: just 30 seconds before and after the intervention
Characterisation of the influence of the intervention on self-confidence	Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)	measured two times: just 30 seconds before and after the intervention
Characterisation of intervention on Psychological stress consequences	Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).	measured two times: just 1 minute before and after the intervention
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)	just 2 minutes after the intervention
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).	just 5 minutes after the intervention

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Investigators: Study Director: Marc Lilot, PhD, Claude Bernard University; Study Chair: Gilles Rode, PhD, Claude Bernard University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: OsceStress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Protocol will be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No