Professional BurnoutNCT04192097
Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation
A study testing Professionalism curriculum in people with Professional Burnout and Professional Stress, run by University Grenoble Alps at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Professional Burnout, Professional Stress, Anesthesia
- What is being tested?
- Professionalism curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2019to 1 Mar 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents in anesthesiology (Postgraduate year 1)
- Voluntary
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. They will go through a standardized simulated scenario where they have to manage an intra-hospital cardiorespiratory arrest and then meet the patient's family. Stress response will be assessed and compared to a control group that did not receive the training program.
- Conditions
- Professional Burnout, Professional Stress, Anesthesia, Medical Education, High Fidelity Simulation, Anxiety State
- Being tested
- Professionalism curriculum
- Keywords
- Cardiopulmonary arrest, Family patient meeting
- Medical subject headings
- Burnout, Professional, Occupational Stress, Anxiety Disorders, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professionalism curriculumOther
One year training program including ten two-hours sessions about
- Knowing yourself
- Interaction with patients and their families
- Teamwork and organization with colleagues
| Study group | Role | What they receive |
|---|---|---|
| Traditional teaching | No intervention | No specific curriculum about professionalism |
| Professionalism curriculum | Experimental | Traditional teaching + professionalism curriculum Receives: Other: Professionalism curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological stress response : State Trait Anxiety Inventory (STAI)
STAI -State (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher
Measured: 1 year
Secondary outcomes (7)
Clinical performance on cardiopulmonary arrest
All simulations will be videotaped and the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist
Measured: 1 year
Physiological stress response : Standard Deviation
Heart rate variability evaluated by Standard Deviation Normal to Normal, in milliseconds. Physiological stress response is higher when Standard Deviation Normal to Normal, is lower.
Measured: 1 year
Family meeting quality : Gather-Resources-Identify-Educate-Verify-Inquire-"Nuts and bolts"-Give
All simulations will be videotaped and the family meeting quality will be assessed by an independent. Score GRIEV-ING from 0 to 27 evaluator, using the Gather, Resources, Identify, Educate, Verify, Inquire, Nuts and bolts, Give), from 0 to 27, family meeting is better when score is higher
Measured: 1 year
Non technical skills (NTS) : Crisis resource management ( CRM). Score Ottawa
Score Ottawa from 5 to 35
Measured: 1 year
Burnout Scale
Maslach Burnout Inventory, from 0 to 132 points, exploring three dimensions of professional burnout
Measured: 1 year
Quality Of Life : WHOQoL
WHOQoL-8 (World Health Organization Quality of Life), from 12 to 60 points, quality of life is higher when the score is lower
Measured: 1 year
Psychological stress response
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Dec 2019
- Primary completion15 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Professional BurnoutStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Grenoble Alps
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre ALBALADEJO, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192097
- Sponsor's protocol ID
- CESAR003
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation
- ClinicalTrials.gov ID
- NCT04192097
- Acronym / sponsor ID
- CESAR003
- Conditions
- Professional Burnout, Professional Stress, Anesthesia, Medical Education, High Fidelity Simulation, Anxiety State
- Keywords
- Cardiopulmonary arrest, Family patient meeting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Grenoble AlpsUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Dec 2019 (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.
The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. They will go through a standardized simulated scenario where they have to manage an intra-hospital cardiorespiratory arrest and then meet the patient's family. Stress response will be assessed and compared to a control group that did not receive the training program.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional teaching | No intervention | –No specific curriculum about professionalism |
| Professionalism curriculum | Experimental | Other: Professionalism curriculumTraditional teaching + professionalism curriculum |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents in anesthesiology (Postgraduate year 1)
- Voluntary
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Professionalism curriculumOne year training program including ten two-hours sessions about * Knowing yourself * Interaction with patients and their families * Teamwork and organization with colleagues | Other | Professionalism curriculum |
Primary outcome
Psychological stress response : State Trait Anxiety Inventory (STAI)
Time frame: 1 year
STAI -State (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher
7 secondary outcomes
Clinical performance on cardiopulmonary arrest
Time frame: 1 year
Physiological stress response : Standard Deviation
Time frame: 1 year
Family meeting quality : Gather-Resources-Identify-Educate-Verify-Inquire-"Nuts and bolts"-Give
Time frame: 1 year
Non technical skills (NTS) : Crisis resource management ( CRM). Score Ottawa
Time frame: 1 year
Burnout Scale
Time frame: 1 year
Quality Of Life : WHOQoL
Time frame: 1 year
Psychological stress response
Time frame: 1 year
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 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professionalism curriculum in people with Professional Burnout and Professional Stress, run by University Grenoble Alps 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 2 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 5 Dec 2023. 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. 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?
Psychological stress response : State Trait Anxiety Inventory (STAI) (time frame: 1 year). 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 5 Dec 2023.