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

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

  • Knowing yourself
  • Interaction with patients and their families
  • Teamwork and organization with colleagues

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.

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

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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