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

C

Claude Bernard University

Status

Completed

Conditions

Stress, Physiological
Stress, Psychological
Exam Stress

Treatments

Other: Mobilization of inner resources
Other: Mindfulness meditation
Other: Biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT05380076
OsceStress

Details and patient eligibility

About

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.

Full 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.

Enrollment

490 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

490 participants in 4 patient groups

Mindfulness
Experimental group
Description:
Mindfulness meditation video before the circuit
Treatment:
Other: Mindfulness meditation
Mobilization of inner resources
Experimental group
Description:
Standardised video before the circuit
Treatment:
Other: Mobilization of inner resources
Biofeedback
Experimental group
Description:
Cardiac biofeedback before the circuit
Treatment:
Other: Biofeedback
Control
Sham Comparator group
Description:
Standardised video before the circuit
Treatment:
Other: Biofeedback
Other: Mindfulness meditation
Other: Mobilization of inner resources

Trial contacts and locations

1

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Central trial contact

Marc Lilot, PhD; Sophie Schlatter

Data sourced from clinicaltrials.gov

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