Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents

Sponsor

University Grenoble Alps (Other)

Overall Status

Unknown status

CT.gov ID

NCT04192097

Collaborator

(none)

Enrollment

Location

Arms

14.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Professional Burnout Professional Stress Anesthesia Medical Education High Fidelity Simulation Anxiety State	Other: Professionalism curriculum	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents

Anticipated Study Start Date :

Dec 15, 2019

Anticipated Primary Completion Date :

Dec 15, 2019

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Traditional teaching No specific curriculum about professionalism
Experimental: Professionalism curriculum Traditionnal teaching + professionalism curriculum	Other: Professionalism curriculum One year training program including ten two-hours sessions about Knowing yourself Interaction with patients and their families Teamwork and organization with colleagues

Arm

Intervention/Treatment

No Intervention: Traditional teaching

No specific curriculum about professionalism

Experimental: Professionalism curriculum

Traditionnal teaching + professionalism curriculum

Other: Professionalism curriculum

One year training program including ten two-hours sessions about Knowing yourself Interaction with patients and their families Teamwork and organization with colleagues

Outcome Measures

Primary Outcome Measures

Psychological stress response : STAI-State [1 year]
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 [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
Physiological stress response : SDNN [1 year]
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 [1 year]
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 [1 year]
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 [1 year]
MBI (Maslach Burnout Inventory), from 0 to 132 points, exploring three dimensions of professional burnout
Quality Of Life : WHOQoL [1 year]
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 [1 year]
Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Residents in anesthesiology (Postgraduate year 1)
Volontary

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Grenoble Alps	La Tronche		France	38700

Sponsors and Collaborators

University Grenoble Alps

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pierre ALBALADEJO, Clinical Professor, University Grenoble Alps

ClinicalTrials.gov Identifier:

NCT04192097

Other Study ID Numbers:

CESAR003

First Posted:

Dec 10, 2019

Last Update Posted:

Dec 10, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pierre ALBALADEJO, Clinical Professor, University Grenoble Alps

Cardiopulmonary arrest

Family patient meeting

Additional relevant MeSH terms:

Occupational Stress

Burnout, Professional

Study Results

No Results Posted as of Dec 10, 2019