Effects of Mindfulness, Mobilization of Resources, or Biofeedback on

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05380076
Study type	Interventional
Source	Claude Bernard University
Contact
Status	Completed
Phase	N/A
Start date	May 17, 2022
Completion date	December 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms