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NCT Number: NCT05390879

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Digestive System Diseases Exam Stress Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Rumination Syndrome Stress, Physiological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marc lilot

Lyon, 69003, France

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Meditation

Other

After the circuit, a 6 minutes long meditation auto-guided video.

Control

Other

After the circuit, a 6 minutes long emotionally neutral video.

Primary outcomes

  1. Change in rumination

    Time frame: 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 outcomes

  1. Physiological stress

    Time frame: During the 6 minutes long intervention (during one hour after inclusion)

    Heart rate variability collected by emWave® devices

  2. Change in psychological stress level

    Time frame: 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

  3. Change in characterisation of stress

    Time frame: 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)

  4. Change in self confidence

    Time frame: 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

  5. Rumination

    Time frame: 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).

  6. Feelings about the intervention

    Time frame: 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

  7. Change in Activation-Deactivation Adjective Check List (Thayer)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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