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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Stress, Physiological; Rumination; Exam Stress
• Intervention / Treatment: Other: Meditation; Other: Control

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..

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Marc lilot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation Post-OSCE; One half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE.	Other: Meditation; After the circuit, a 6 minutes long meditation auto-guided video.
Sham Comparator: Control; One half of the students will watch a 6 minutes control video, just after the OSCE	Other: Control; After the circuit, a 6 minutes long emotionally neutral video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rumination	BSRI - Brief State Rumination Inventory, assessing state-rumination	Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological stress	Heart rate variability collected by emWave® devices	During the 6 minutes long intervention (during one hour after inclusion)
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	Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
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)	Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Change in self confidence	Chraracterisation of the impact of meditation on numerical VAS on self confidence perceived from zero to maximum : 100mm	Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
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).	One time : After intervention (during one hour after inclusion)
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	One time : After intervention (during one hour after inclusion)
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.	Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Investigators: Study Chair: Gilles Rode, MD, PhD, Claude Bernard University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Stress; Meditation; Coping; Performance and ruminations; Rumination; Exam; health-student
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Feeding and Eating Disorders; Gastrointestinal Diseases; Stress, Psychological; Rumination Syndrome; Feeding and Eating Disorders of Childhood
• Other Study ID Numbers: IMSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No