- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192097
Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation
November 28, 2023 updated by: Pierre ALBALADEJO, University Grenoble Alps
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
La Tronche, France, 38700
- University hospital Grenoble Alps
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Residents in anesthesiology (Postgraduate year 1)
- Voluntary
Exclusion Criteria:
- /
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Traditional teaching
No specific curriculum about professionalism
|
|
Experimental: Professionalism curriculum
Traditional teaching + professionalism curriculum
|
One year training program including ten two-hours sessions about
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical performance on cardiopulmonary arrest
Time Frame: 1 year
|
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
|
1 year
|
Physiological stress response : Standard Deviation
Time Frame: 1 year
|
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.
|
1 year
|
Family meeting quality : Gather-Resources-Identify-Educate-Verify-Inquire-"Nuts and bolts"-Give
Time Frame: 1 year
|
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
|
1 year
|
Non technical skills (NTS) : Crisis resource management ( CRM). Score Ottawa
Time Frame: 1 year
|
Score Ottawa from 5 to 35
|
1 year
|
Burnout Scale
Time Frame: 1 year
|
Maslach Burnout Inventory, from 0 to 132 points, exploring three dimensions of professional burnout
|
1 year
|
Quality Of Life : WHOQoL
Time Frame: 1 year
|
WHOQoL-8 (World Health Organization Quality of Life), from 12 to 60 points, quality of life is higher when the score is lower
|
1 year
|
Psychological stress response
Time Frame: 1 year
|
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2019
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
December 5, 2019
First Posted (Actual)
December 10, 2019
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CESAR003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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