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Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)

Primary Purpose

Stress, Psychological, Stress, Physiological, Rumination

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Meditation
Control
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological focused on measuring Stress, Performance and ruminations, Coping, Rumination, Meditation, Exam, health-student

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Marc lilot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Meditation Post-OSCE

Control

Arm Description

One half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE.

One half of the students will watch a 6 minutes control video, just after the OSCE

Outcomes

Primary Outcome Measures

Change in rumination
BSRI - Brief State Rumination Inventory, assessing state-rumination

Secondary Outcome Measures

Physiological stress
Heart rate variability collected by emWave® devices
Change in psychological stress level
Chraracterisation of the impact of meditation on numerical Visual analog scales (VAS) on perceived stress from zero to maximum: 100mm
Change in characterisation of stress
Chraracterisation of the impact of meditation on numerical VAS on characterisation of stress perceived from 0mm (negative stress) to 100mm (positive stress)
Change in self confidence
Chraracterisation of the impact of meditation on numerical VAS on self confidence perceived from zero to maximum : 100mm
Rumination
Momentary Ruminative Self-focused Inventory (MRSI), 4 items long questionnaire assessing state-rumination. The goal of this outcome is to confront the french version of the MRSI (validated and published), and the newly translated BMRSI (B momentary ruminative self-focus inventory).
Feelings about the intervention
Chraracterisation of the impact of meditation on a 5 items Likert Scale (from 0: Not at all, to maximum: very high intensity) assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun
Change in Activation-Deactivation Adjective Check List (Thayer)
Chraracterisation of the impact of meditation on activation-deactivation among students. The AD-ACL is a multidimensional test of various transitory arousal states, including energetic and tense arousal. Within the wider dimensions of energetic and tense arousal are four sub-scales-Energy (General Activation), Tiredness (Deactivation-Sleep), Tension (High Activation), and Calmness (General Deactivation), from 5 to maximum: 20 points for each dimension.

Full Information

First Posted
May 12, 2022
Last Updated
November 6, 2022
Sponsor
Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT05390879
Brief Title
Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)
Official Title
Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress and rumination are linked with the development of many mental disorders. The ECOSTRESS study has shown that poor OSCE performance has a positive effect on the occurence of state-rumination among 4th year medicine students in the context of mock exams. The goal of IMSR study is to assess the effectiveness of a post-OSCE meditation intervention to decrease psychological stress and rumination.
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. Before the test (OSCE), all the students will receive information about the study and formalize their consent. The students' OSCE performance will be evaluated by an independent examiner as part of the students' exams. Upon finishing the OSCE, the students will be divided into two groups: one subjected to post-OSCE meditation and the other one subjected to a control intervention (neutral content video). Before both interventions, all the students will be submitted to short questionnaires regarding their feelings. During the 6-min intervention they will be get equipped with an ear pulse sensor. Following both interventions, all the students will be submitted to short questionnaires regarding their stress and rumination levels. The main objective is to assess the effectiveness of meditation intervention to diminish post-OSCE rumination level. The second objective is to have a deeper understanding of the cause of rumination following the OSCE..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Rumination, Exam Stress
Keywords
Stress, Performance and ruminations, Coping, Rumination, Meditation, Exam, health-student

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 parallels groups
Masking
ParticipantOutcomes Assessor
Masking Description
Assessors are blind concerning the principal outcome (ruminations and post-OSCE meditation groups, via standardized informatic questionnaires) Performance is evaluated by assessors who are blind to the intervention
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Post-OSCE
Arm Type
Experimental
Arm Description
One half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
One half of the students will watch a 6 minutes control video, just after the OSCE
Intervention Type
Other
Intervention Name(s)
Meditation
Intervention Description
After the circuit, a 6 minutes long meditation auto-guided video.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
After the circuit, a 6 minutes long emotionally neutral video.
Primary Outcome Measure Information:
Title
Change in rumination
Description
BSRI - Brief State Rumination Inventory, assessing state-rumination
Time Frame
Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Secondary Outcome Measure Information:
Title
Physiological stress
Description
Heart rate variability collected by emWave® devices
Time Frame
During the 6 minutes long intervention (during one hour after inclusion)
Title
Change in psychological stress level
Description
Chraracterisation of the impact of meditation on numerical Visual analog scales (VAS) on perceived stress from zero to maximum: 100mm
Time Frame
Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Title
Change in characterisation of stress
Description
Chraracterisation of the impact of meditation on numerical VAS on characterisation of stress perceived from 0mm (negative stress) to 100mm (positive stress)
Time Frame
Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Title
Change in self confidence
Description
Chraracterisation of the impact of meditation on numerical VAS on self confidence perceived from zero to maximum : 100mm
Time Frame
Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Title
Rumination
Description
Momentary Ruminative Self-focused Inventory (MRSI), 4 items long questionnaire assessing state-rumination. The goal of this outcome is to confront the french version of the MRSI (validated and published), and the newly translated BMRSI (B momentary ruminative self-focus inventory).
Time Frame
One time : After intervention (during one hour after inclusion)
Title
Feelings about the intervention
Description
Chraracterisation of the impact of meditation on a 5 items Likert Scale (from 0: Not at all, to maximum: very high intensity) assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun
Time Frame
One time : After intervention (during one hour after inclusion)
Title
Change in Activation-Deactivation Adjective Check List (Thayer)
Description
Chraracterisation of the impact of meditation on activation-deactivation among students. The AD-ACL is a multidimensional test of various transitory arousal states, including energetic and tense arousal. Within the wider dimensions of energetic and tense arousal are four sub-scales-Energy (General Activation), Tiredness (Deactivation-Sleep), Tension (High Activation), and Calmness (General Deactivation), from 5 to maximum: 20 points for each dimension.
Time Frame
Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult person Registered as medical student at the university Participating at OSCE examination Have signed an informed consent form. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Rode, MD, PhD
Organizational Affiliation
Claude Bernard University
Official's Role
Study Chair
Facility Information:
Facility Name
Marc lilot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)

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