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

Sponsor

Claude Bernard University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05390879

Collaborator

(none)

480

Enrollment

Arms

Anticipated Duration (Days)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological Stress, Physiological Rumination Exam Stress	Other: Meditation Other: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 parallels groups2 parallels groups

Masking:

Double (Participant, Outcomes 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

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

May 20, 2022

Anticipated Study Completion Date :

Jun 10, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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