NCT04192097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

December 5, 2019

Last Update Submit

November 28, 2023

Conditions

Professional BurnoutProfessional StressAnesthesiaMedical EducationHigh Fidelity SimulationAnxiety State

Keywords

Cardiopulmonary arrestFamily patient meeting

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (7)

  • Clinical performance on cardiopulmonary arrest

    1 year

  • Physiological stress response : Standard Deviation

    1 year

  • Family meeting quality : Gather-Resources-Identify-Educate-Verify-Inquire-"Nuts and bolts"-Give

    1 year

  • Non technical skills (NTS) : Crisis resource management ( CRM). Score Ottawa

    1 year

  • Burnout Scale

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Traditional teaching

NO INTERVENTION

No specific curriculum about professionalism

Professionalism curriculum

EXPERIMENTAL

Traditional teaching + professionalism curriculum

Other: Professionalism curriculum

Interventions

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

Professionalism curriculum

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents in anesthesiology (Postgraduate year 1)
  • Voluntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Grenoble Alps

La Tronche, 38700, France

Location

MeSH Terms

Conditions

Burnout, ProfessionalOccupational StressAnxiety DisordersHeart Arrest

Condition Hierarchy (Ancestors)

Occupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorMental DisordersHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 10, 2019

Study Start

December 15, 2019

Primary Completion

January 15, 2021

Study Completion

March 1, 2021

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

FR(1)