Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents
Primary Purpose
Professional Burnout, Professional Stress, Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Professionalism curriculum
Sponsored by
About this trial
This is an interventional prevention trial for Professional Burnout focused on measuring Cardiopulmonary arrest, Family patient meeting
Eligibility Criteria
Inclusion Criteria:
- Residents in anesthesiology (Postgraduate year 1)
- Volontary
Exclusion Criteria:
- /
Sites / Locations
- University Grenoble Alps
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Traditional teaching
Professionalism curriculum
Arm Description
No specific curriculum about professionalism
Traditionnal teaching + professionalism curriculum
Outcomes
Primary Outcome Measures
Psychological stress response : STAI-State
STAI -State (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher
Secondary Outcome Measures
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
Physiological stress response : SDNN
Heart rate variability evaluated by SDNN (Standard Deviation Normal to Normal), in miliseconds. Physiological stress response is higher when SDNN is lower.
Family meeting quality
All simulations will be videotaped and the family meeting quality will be assessed by an independent evaluator, using the GRIEV_ING modified for anesthesiologist (Gather, Resources, Identify, Educate, Verify, Inquire, Nuts and bolts, Give), from 0 to 27, family meeting is better when score is higher
Non technical skills: Crisis ressources management
All simulations will be videotaped and the crisis ressources management of each participant will be assessed by an independent evaluator using the Ottawa global rating scale during cardiopulmonary arrest
Burnout Scale
MBI (Maslach Burnout Inventory), from 0 to 132 points, exploring three dimensions of professional burnout
Quality Of Life : WHOQoL
WHOQoL-8 (World Health Organization Quality of Life), from 12 to 62 points, quality of life is higher when the score is lower
Psychological stress response : Stress-VAS
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher
Full Information
NCT ID
NCT04192097
First Posted
December 5, 2019
Last Updated
December 5, 2019
Sponsor
University Grenoble Alps
1. Study Identification
Unique Protocol Identification Number
NCT04192097
Brief Title
Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents
Official Title
Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2019 (Anticipated)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Grenoble Alps
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Professional Burnout, Professional Stress, Anesthesia, Medical Education, High Fidelity Simulation, Anxiety State
Keywords
Cardiopulmonary arrest, Family patient meeting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional teaching
Arm Type
No Intervention
Arm Description
No specific curriculum about professionalism
Arm Title
Professionalism curriculum
Arm Type
Experimental
Arm Description
Traditionnal teaching + professionalism curriculum
Intervention Type
Other
Intervention Name(s)
Professionalism curriculum
Intervention Description
One year training program including ten two-hours sessions about
Knowing yourself
Interaction with patients and their families
Teamwork and organization with colleagues
Primary Outcome Measure Information:
Title
Psychological stress response : STAI-State
Description
STAI -State (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical performance on cardiopulmonary arrest
Description
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
Time Frame
1 year
Title
Physiological stress response : SDNN
Description
Heart rate variability evaluated by SDNN (Standard Deviation Normal to Normal), in miliseconds. Physiological stress response is higher when SDNN is lower.
Time Frame
1 year
Title
Family meeting quality
Description
All simulations will be videotaped and the family meeting quality will be assessed by an independent evaluator, using the GRIEV_ING modified for anesthesiologist (Gather, Resources, Identify, Educate, Verify, Inquire, Nuts and bolts, Give), from 0 to 27, family meeting is better when score is higher
Time Frame
1 year
Title
Non technical skills: Crisis ressources management
Description
All simulations will be videotaped and the crisis ressources management of each participant will be assessed by an independent evaluator using the Ottawa global rating scale during cardiopulmonary arrest
Time Frame
1 year
Title
Burnout Scale
Description
MBI (Maslach Burnout Inventory), from 0 to 132 points, exploring three dimensions of professional burnout
Time Frame
1 year
Title
Quality Of Life : WHOQoL
Description
WHOQoL-8 (World Health Organization Quality of Life), from 12 to 62 points, quality of life is higher when the score is lower
Time Frame
1 year
Title
Psychological stress response : Stress-VAS
Description
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Residents in anesthesiology (Postgraduate year 1)
Volontary
Exclusion Criteria:
/
Facility Information:
Facility Name
University Grenoble Alps
City
La Tronche
ZIP/Postal Code
38700
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents
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