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

Not Applicable

Completed

• Conditions: Exam Stress; Stress, Physiological; Stress, Psychological
• Interventions: Other: Mindfulness meditation; Other: Biofeedback; Other: Mobilization of inner resources

• Registration Number: NCT05380076
• Lead Sponsor: Claude Bernard University

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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study Start: 2022-05-17
• Study First Posted: 2022-05-18
• Primary Completion: 2022-06-30
• Study Completion: 2023-12-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Mobilization of inner resources	Standardised video before the circuit
Mindfulness	Mindfulness meditation	Mindfulness meditation video before the circuit
Mobilization of inner resources	Mobilization of inner resources	Standardised video before the circuit
Biofeedback	Biofeedback	Cardiac biofeedback before the circuit
Control	Mindfulness meditation	Standardised video before the circuit
Control	Biofeedback	Standardised video before the circuit

Primary Outcome Measures

Name	Time	Method
Differences of physiological stress	During the 6min long intervention	Heart rate variability collected by an ear pulse sensor (emWave® device)

Secondary Outcome Measures

Name	Time	Method
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).
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)
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)
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)
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).
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)

Trial Locations

Locations (1)

Claude Bernard University; 🇫🇷 Lyon, France