Exam StressNCT05380076
Effects of Mindfulness, Mobilization of Resources, or Biofeedback on Stress Before OSCE
A study testing Mindfulness meditation, Mobilization of inner resources and Biofeedback in people with Exam Stress and Stress, Psychological, run by Claude Bernard University at 1 site in France.
Trial summary
Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exam Stress, Stress, Psychological, Stress, Physiological
- What is being tested?
- Mindfulness meditation, Mobilization of inner resources and Biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2022to 30 Dec 2023
- 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
Official title: Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students.
Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.
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.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long.
The randomisation groups are:
- Mindfulness through watching/listening video tape
- Mobilization of inner resources through watching/listening video tape
- Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score
- Unemotional video tape as controlled group
Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality.
Main objective is to show that interventions are better than control to reduce stress level before OSCE.
The main outcome is to compare the effect of the interventions on physiological stress, using HRV as physiological stress marker.
Secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. Finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.
- Conditions
- Exam Stress, Stress, Psychological, Stress, Physiological
- Being tested
- Mindfulness meditation, Mobilization of inner resources, Biofeedback
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationOther
6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.
Mobilization of inner resourcesOther
6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit
BiofeedbackOther
6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Mindfulness meditation video before the circuit Receives: Other: Mindfulness meditation |
| Mobilization of inner resources | Experimental | Standardised video before the circuit Receives: Other: Mobilization of inner resources |
| Biofeedback | Experimental | Cardiac biofeedback before the circuit Receives: Other: Biofeedback |
| Control | Sham comparator | Standardised video before the circuit Receives: Other: Mindfulness meditation; Other: Mobilization of inner resources; Other: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of physiological stress
Heart rate variability collected by an ear pulse sensor (emWave® device)
Measured: During the 6min long intervention
Secondary outcomes (6)
Characterisation of the influence of the intervention on Psychological stress
Numerical Visual analog scales (100mm-VAS) on perceived stress (from zero to 100: maximum)
Measured: measured two times: just 30 seconds before and after the intervention
Characterisation of the influence of the intervention on level of inner resources
Numerical 100mm-VAS on level of resourcefulness perceived (from zero to 100: maximum)
Measured: measured two times: just 30 seconds before and after the intervention
Characterisation of the influence of the intervention on self-confidence
Numerical 100mm-VAS on self confidence perceived (from zero to 100: maximum)
Measured: measured two times: just 30 seconds before and after the intervention
Characterisation of intervention on Psychological stress consequences
Activation-Deactivation Adjective Check List: for the four subscales (Tension , Calmness, Activation, Deactivation).
Measured: measured two times: just 1 minute before and after the intervention
Feelings about the intervention
Likert Scale assessing feelings about the intervention: Pleasure, Interest, Enthusiasm, Boredom, Frustration, Discouragement, Fun) on a 5 items answers (from not feeling at all, to very importante intensity)
Measured: just 2 minutes after the intervention
Determining influence of personality traits on the efficiency on the intervention
Personality questionnaire (Big-5, 10 items) allowing score in 5 factors of personality (Openness, Consciousness, Extraversion, Agreeableness, Nevrosism).
Measured: just 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start17 May 2022
- Primary completion30 Jun 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exam StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 490 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, PhD, Study chair, Claude Bernard UniversityMarc Lilot, PhD, Study director, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380076
- Sponsor's protocol ID
- OsceStress
- Status last verified
- Jun 2024
- First submitted
- 13 May 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students
- ClinicalTrials.gov ID
- NCT05380076
- Acronym / sponsor ID
- OsceStress
- Conditions
- Exam Stress, Stress, Psychological, Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 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 generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students.
Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.
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.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long.
The randomisation groups are:
- Mindfulness through watching/listening video tape
- Mobilization of inner resources through watching/listening video tape
- Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score
- Unemotional video tape as controlled group
Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality.
Main objective is to show that interventions are better than control to reduce stress level before OSCE.
The main outcome is to compare the effect of the interventions on physiological stress, using HRV as physiological stress marker.
Secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. Finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Other: Mindfulness meditationMindfulness meditation video before the circuit |
| Mobilization of inner resources | Experimental | Other: Mobilization of inner resourcesStandardised video before the circuit |
| Biofeedback | Experimental | Other: BiofeedbackCardiac biofeedback before the circuit |
| Control | Sham comparator | Other: Mindfulness meditation, Other: Mobilization of inner resources, Other: BiofeedbackStandardised video before the circuit |
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 |
|---|---|---|
| Mindfulness meditation6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit. | Other | Control, Mindfulness |
| Mobilization of inner resources6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit | Other | Control, Mobilization of inner resources |
| Biofeedback6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit. | Other | Biofeedback, Control |
Primary outcome
Differences of physiological stress
Time frame: During the 6min long intervention
Heart rate variability collected by an ear pulse sensor (emWave® device)
6 secondary outcomes
Characterisation of the influence of the intervention on Psychological stress
Time frame: measured two times: just 30 seconds before and after the intervention
Characterisation of the influence of the intervention on level of inner resources
Time frame: measured two times: just 30 seconds before and after the intervention
Characterisation of the influence of the intervention on self-confidence
Time frame: measured two times: just 30 seconds before and after the intervention
Characterisation of intervention on Psychological stress consequences
Time frame: measured two times: just 1 minute before and after the intervention
Feelings about the intervention
Time frame: just 2 minutes after the intervention
Determining influence of personality traits on the efficiency on the intervention
Time frame: just 5 minutes after the intervention
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 18 Jun 2024.
- Individual participant dataSharing planned: No. Protocol will be available on request
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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, PhD study chair
Claude Bernard University
Marc Lilot, PhD study director
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 Mindfulness meditation, Mobilization of inner resources and Biofeedback in people with Exam Stress and Stress, Psychological, 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 18 Jun 2024. 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?
Differences of physiological stress (time frame: During the 6min long intervention). 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 18 Jun 2024.