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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05380076
Enrollment
490
Registered
2022-05-18
Start date
2022-05-17
Completion date
2023-12-30
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exam Stress, Stress, Physiological, Stress, Psychological

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.

Interventions

OTHERMindfulness meditation

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

OTHERMobilization of inner resources

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

OTHERBiofeedback

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.

Sponsors

Claude Bernard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Interventions are standardized video tape. Information collected through standardized informatic questionnaires for blinded investigators.

Intervention model description

4 parallel groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Differences of physiological stressDuring the 6min long interventionHeart rate variability collected by an ear pulse sensor (emWave® device)

Secondary

MeasureTime frameDescription
Characterisation of the influence of the intervention on level of inner resourcesmeasured two times: just 30 seconds before and after the interventionNumerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum)
Characterisation of the influence of the intervention on self-confidencemeasured two times: just 30 seconds before and after the interventionNumerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)
Characterisation of the influence of the intervention on Psychological stressmeasured two times: just 30 seconds before and after the interventionNumerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)
Feelings about the interventionjust 2 minutes after the interventionLikert 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)
Determining influence of personality traits on the efficiency on the interventionjust 5 minutes after the interventionPersonality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism).
Characterisation of intervention on Psychological stress consequencesmeasured two times: just 1 minute before and after the interventionActivation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026