Clinical Trials Directory

Trials / Completed

CompletedNCT05380076

Effects of Mindfulness, Mobilization of Resources, or Biofeedback on Stress Before OSCE

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
490 (actual)
Sponsor
Claude Bernard University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMindfulness meditation6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.
OTHERMobilization of inner resources6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit
OTHERBiofeedback6 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.

Timeline

Start date
2022-05-17
Primary completion
2022-06-30
Completion
2023-12-30
First posted
2022-05-18
Last updated
2024-06-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05380076. Inclusion in this directory is not an endorsement.