Skip to main content
OpenTrials
Completed

NCT Number: NCT05380076

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exam Stress Behavior Behavioral Symptoms Stress, Physiological Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Claude Bernard University

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Mindfulness meditation

Other

6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.

Mobilization of inner resources

Other

6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit

Biofeedback

Other

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.

Primary outcomes

  1. Differences of physiological stress

    Time frame: During the 6min long intervention

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

Secondary outcomes

  1. Characterisation of the influence of the intervention on Psychological stress

    Time frame: 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 level of inner resources

    Time frame: measured two times: just 30 seconds before and after the intervention

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

  3. Characterisation of the influence of the intervention on self-confidence

    Time frame: measured two times: just 30 seconds before and after the intervention

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

  4. Characterisation of intervention on Psychological stress consequences

    Time frame: measured two times: just 1 minute before and after the intervention

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

  5. Feelings about the intervention

    Time frame: 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)

  6. Determining influence of personality traits on the efficiency on the intervention

    Time frame: just 5 minutes after the intervention

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

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 18, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.