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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390879
• Other study ID #: IMSR
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: November 2022
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 10, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult person

• Registered as medical student at the university

• Participating at OSCE examination

• Have signed an informed consent form.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Feeding and Eating Disorders of Childhood
• Rumination
• Stress, Physiological
• Stress, Psychological

Intervention

Other:
• Meditation
After the circuit, a 6 minutes long meditation auto-guided video.
• Control
After the circuit, a 6 minutes long emotionally neutral video.

Locations

Country	Name	City	State
France	Marc lilot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physiological stress	Heart rate variability collected by emWave® devices	During the 6 minutes long intervention (during one hour after inclusion)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)