Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05380076
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-05-13
Brief Title:
Effects of Mindfulness Mobilization of Resources or Biofeedback on Stress Before OSCE
Sponsor:
Claude Bernard University
Organization:
Claude Bernard University
Study Overview
Official Title:
Effects of Mindfulness Mobilization of Inner Resources or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 universityAll 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 watchinglistening video tape
Mobilization of inner resources through watchinglistening 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
The randomisation groups are
Mindfulness through watchinglistening video tape
Mobilization of inner resources through watchinglistening 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None