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

Sponsor
Claude Bernard University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05380076
Collaborator
(none)
490
4
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mindfulness meditation
  • Other: Mobilization of inner resources
  • Other: Biofeedback
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 parallel groups4 parallel groups
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Interventions are standardized video tape. Information collected through standardized informatic questionnaires for blinded investigators.
Primary Purpose:
Prevention
Official Title:
Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Anticipated Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Differences of physiological stress [During the 6min long intervention]

    Heart rate variability collected by an ear pulse sensor (emWave® device)

Secondary Outcome Measures

  1. Characterisation of the influence of the intervention on Psychological stress [measured two times: just 30 seconds before and after the intervention]

    Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)

  2. Characterisation of the influence of the intervention on Psychological stress [measured two times: just 30 seconds before and after the intervention]

    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)

  3. Characterisation of the influence of the intervention on level of inner resources [measured two times: just 30 seconds before and after the intervention]

    Numerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum)

  4. Characterisation of the influence of the intervention on self-confidence [measured two times: just 30 seconds before and after the intervention]

    Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)

  5. Characterisation of intervention on Psychological stress consequences [measured two times: just 1 minute before and after the intervention]

    Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).

  6. Feelings about the intervention [just 2 minutes after 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)

  7. Determining influence of personality traits on the efficiency on the intervention [just 5 minutes after the intervention]

    Personality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult person

  • Registered as medical student at the university

  • Participating at OSCE examination

  • Have signed an informed consent form.

Exclusion Criteria:
  • None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Claude Bernard University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lilot Marc, Principal investigator, Claude Bernard University
ClinicalTrials.gov Identifier:
NCT05380076
Other Study ID Numbers:
  • OsceStress
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022