Stress, PsychologicalNCT05390879
Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)
A study testing Meditation in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Physiological, Rumination
- What is being tested?
- Meditation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2022to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult person
- Registered as medical student at the university
- Participating at OSCE examination
- Have signed an informed consent form.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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..
- Conditions
- Stress, Psychological, Stress, Physiological, Rumination, Exam Stress
- Being tested
- Meditation, Control
- Keywords
- Stress, Performance and ruminations, Coping, Rumination, Meditation, Exam, health-student
- Medical subject headings
- Stress, Psychological, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
After the circuit, a 6 minutes long meditation auto-guided video.
ControlOther
After the circuit, a 6 minutes long emotionally neutral video.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Post-OSCE | Experimental | One half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE. Receives: Other: Meditation |
| Control | Sham comparator | One half of the students will watch a 6 minutes control video, just after the OSCE Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rumination
BSRI - Brief State Rumination Inventory, assessing state-rumination
Measured: Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Secondary outcomes (7)
Physiological stress
Heart rate variability collected by emWave® devices
Measured: 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
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start17 May 2022
- Primary completion20 May 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallels groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Gilles Rode, MD, PhD, Study chair, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390879
- Sponsor's protocol ID
- IMSR
- Status last verified
- Nov 2022
- First submitted
- 12 May 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)
- ClinicalTrials.gov ID
- NCT05390879
- Acronym / sponsor ID
- IMSR
- Conditions
- Stress, Psychological, Stress, Physiological, Rumination, Exam Stress
- Keywords
- Stress, Performance and ruminations, Coping, Rumination, Meditation, Exam, health-student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallels groups
| Arm | Type | Receives |
|---|---|---|
| Meditation Post-OSCE | Experimental | Other: MeditationOne half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE. |
| Control | Sham comparator | Other: ControlOne half of the students will watch a 6 minutes control video, just after the OSCE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult person
- Registered as medical student at the university
- Participating at OSCE examination
- Have signed an informed consent form.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationAfter the circuit, a 6 minutes long meditation auto-guided video. | Other | Meditation Post-OSCE |
| ControlAfter the circuit, a 6 minutes long emotionally neutral video. | Other | Control |
Primary outcome
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
7 secondary outcomes
Physiological stress
Time frame: During the 6 minutes long intervention (during one hour after inclusion)
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)
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)
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)
Rumination
Time frame: One time : After intervention (during one hour after inclusion)
Feelings about the intervention
Time frame: One time : After intervention (during one hour after inclusion)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Rode, MD, PhD study chair
Claude Bernard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.