Performance AnxietyZENECOSNCT06466993
Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination
A study testing Intervention of standardized relaxing breathing in people with Performance Anxiety and Stress, run by Claude Bernard University.
Trial summary
SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Performance Anxiety, Stress, Coping Skills
- What is being tested?
- Intervention of standardized relaxing breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to 17 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all volontary medical students of the second cycle that came for their exam during the sessions of June 2024 from the University of Lyon (Medecine ESt)
Who cannot join
- no exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence on Performance of Relaxing Breathing During Rotation Pause Before Each Station of an Objective Structured Clinical Examination for Fifth Year Medical Students
SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.
The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.
Read the detailed description
Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is 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 a standardized relaxing breathing as a coping interventions occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.
- Conditions
- Performance Anxiety, Stress, Coping Skills
- Being tested
- Intervention of standardized relaxing breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of standardized relaxing breathingBehavioural
Relaxing breathing standardized to 6 respiratory cycles per minute that occur during rotation time before next station of OSCE start
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Relaxing breathing occuring during rotation of OSCE station Receives: Behavioral: Intervention of standardized relaxing breathing |
| Control | Active comparator | Free time during rotation of OSCE station Receives: Behavioral: Intervention of standardized relaxing breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PERFORMANCE
Score at the objectif structured clinical examination exam from 0 minimum to 200 points maximum
Measured: obtained seven days after the objectif structured clinical examination
Secondary outcomes (2)
Mean Difference of Inner Resource
Numerical Visual analog score on inner resource available perceived (from 0 to 100 : maximum)
Measured: Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)
Mean difference of perceived impact of the intervention on performance
Numerical Visual analog scales on perceived impact of the intervention on performance (from zero: negative to 100: positive)
Measured: Just five minutes after the objectif structured clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start5 Sep 2024 (estimated)
- Primary completion17 Dec 2024 (estimated)
- Study completion17 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance AnxietyStudies 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
- Prospective randomized controlle monocentric
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
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, Lyon Est Medical Center Lyon 1 UniversityEvan Gouy, MD, Principal investigator, Lyon Est Medical Center Lyon 1 UniversityMarion Cortet, MD PhD, Study director, Lyon Est Medical Center Lyon 1 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466993
- Sponsor's protocol ID
- ZENECOS
- Acronym
- ZENECOS
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Performance of Relaxing Breathing During Rotation Pause Before Each Station of an Objective Structured Clinical Examination for Fifth Year Medical Students
- ClinicalTrials.gov ID
- NCT06466993
- Acronym / sponsor ID
- ZENECOS / ZENECOS
- Conditions
- Performance Anxiety, Stress, Coping Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 17 Dec 2024 (estimated)
- Study completion
- 17 Dec 2024 (estimated)
- First posted
- 20 Jun 2024 (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.
SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.
The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.
Detailed description
Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is 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 a standardized relaxing breathing as a coping interventions occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlle monocentric
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention of standardized relaxing breathingRelaxing breathing occuring during rotation of OSCE station |
| Control | Active comparator | Behavioral: Intervention of standardized relaxing breathingFree time during rotation of OSCE station |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all volontary medical students of the second cycle that came for their exam during the sessions of June 2024 from the University of Lyon (Medecine ESt)
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Intervention of standardized relaxing breathingRelaxing breathing standardized to 6 respiratory cycles per minute that occur during rotation time before next station of OSCE start | Behavioural | Control, Intervention |
Primary outcome
PERFORMANCE
Time frame: obtained seven days after the objectif structured clinical examination
Score at the objectif structured clinical examination exam from 0 minimum to 200 points maximum
2 secondary outcomes
Mean Difference of Inner Resource
Time frame: Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)
Mean difference of perceived impact of the intervention on performance
Time frame: Just five minutes after the objectif structured clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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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
Lyon Est Medical Center Lyon 1 University
Evan Gouy, MD principal investigator
Lyon Est Medical Center Lyon 1 University
Marion Cortet, MD PhD study director
Lyon Est Medical Center Lyon 1 University
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of standardized relaxing breathing in people with Performance Anxiety and Stress, run by Claude Bernard University.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Lilot, MD PhD (0651806521, marc.lilot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERFORMANCE (time frame: obtained seven days after the objectif structured clinical examination). 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 14 Aug 2024.