Clinical trial NCT05380076: Effects of Mindfulness, Mobilization of Resources, or Biofeedback on Stress Before OSCE
Official title: Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exam Stress
Stress, Psychological
Stress, Physiological
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 parallel groups
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Differences of physiological stress
timeFrame: During the 6min long intervention
Secondary outcomes:
measure: Characterisation of the influence of the intervention on Psychological stress
timeFrame: measured two times: just 30 seconds before and after the intervention
measure: Characterisation of the influence of the intervention on level of inner resources
timeFrame: measured two times: just 30 seconds before and after the intervention
measure: Characterisation of the influence of the intervention on self-confidence
timeFrame: measured two times: just 30 seconds before and after the intervention
measure: Characterisation of intervention on Psychological stress consequences
timeFrame: measured two times: just 1 minute before and after the intervention
measure: Feelings about the intervention
timeFrame: just 2 minutes after the intervention
measure: Determining influence of personality traits on the efficiency on the intervention
timeFrame: just 5 minutes after the intervention
Other outcomes:
Locations:
city: Lyon
country: France
facility: Claude Bernard University
Study officials:
affiliation: Claude Bernard University
name: Gilles Rode, PhD
role: STUDY_CHAIR
affiliation: Claude Bernard University
name: Marc Lilot, PhD
role: STUDY_DIRECTOR
References: