NCT05073445

Brief Summary

The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

July 29, 2021

Last Update Submit

March 17, 2022

Conditions

Stress, ProfessionalResilienceAnaesthesiologyHigh Fidelity Simulation

Outcome Measures

Primary Outcomes (2)

  • Heart rate variability

    Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants

    during the laryngospasm (during 3 minutes at 6 minutes)

  • Resilience

    Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants. A high score indicates better resilience.

    5 days before scenario

Secondary Outcomes (16)

  • Self-reported stress

    5 days before scenario

  • Self-reported stress

    just Before the scenario (at 0 minute )

  • Self-reported stress

    just after briefing (at 3 minutes)

  • Self-reported stress

    just after the end of scenario (at 9 minutes)

  • Self-reported stress

    just after the debriefing (at 30 minutes)

  • +11 more secondary outcomes

Interventions

SDNN measurementBEHAVIORAL

SDNN measurement during pediatric simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anaesthetic teams composed with : * 1 resident in anaesthesiology and critical care OR Anesthesiologist AND * 1 anaesthetic nursing student OR 1 anaesthetic nurse graduated

You may qualify if:

  • \- volunteer in anesthesia

You may not qualify if:

  • Rhythm disorders
  • Endocrine pathology
  • High blood pressure
  • Pregnancy or breastfeeding in progress
  • Taking anti-inflammatory or psychotropic drugs that interfere with the heart rate
  • Interruption of professional practice in anesthesia \> 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Yoann Zafiriou

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Julien Picard, M.D, Ph.D.

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

October 11, 2021

Study Start

June 18, 2021

Primary Completion

October 13, 2021

Study Completion

November 15, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

FR(1)