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

NCT ID: NCT05380076

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2023-12-30

Brief Summary

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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

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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

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Exam Stress Stress, Psychological Stress, Physiological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 parallel groups
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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Mindfulness

Mindfulness meditation video before the circuit

Group Type EXPERIMENTAL

Mindfulness meditation

Intervention Type 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

Standardised video before the circuit

Group Type EXPERIMENTAL

Mobilization of inner resources

Intervention Type OTHER

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

Biofeedback

Cardiac biofeedback before the circuit

Group Type EXPERIMENTAL

Biofeedback

Intervention Type 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.

Control

Standardised video before the circuit

Group Type SHAM_COMPARATOR

Mindfulness meditation

Intervention Type 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

Intervention Type OTHER

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

Biofeedback

Intervention Type 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.

Interventions

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Mindfulness meditation

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

Intervention Type OTHER

Mobilization of inner resources

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

Intervention Type OTHER

Biofeedback

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Claude Bernard University

OTHER

Sponsor Role lead

Responsible Party

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Lilot Marc

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilles Rode, PhD

Role: STUDY_CHAIR

Claude Bernard University

Marc Lilot, PhD

Role: STUDY_DIRECTOR

Claude Bernard University

Locations

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Claude Bernard University

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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OsceStress

Identifier Type: -

Identifier Source: org_study_id

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