NCT05353621

Brief Summary

The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 25, 2022

Last Update Submit

November 29, 2022

Conditions

Stress, ProfessionalResilienceAnaesthesiologySimulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    15 Days after simulation

  • Self-reported stress

    Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).

    just Before the scenario (at 0 minute )

Secondary Outcomes (6)

  • Performance

    just after the end of scenario (at 10 minute)

  • resilience of anesthetists

    15 Days after simulation

  • resilience of Resident in anaesthesia

    15 Days after simulation

  • resilience of nurse anesthetist

    15 Days after simulation

  • resilience of the student nurse anesthetist

    15 Days after simulation

  • +1 more secondary outcomes

Interventions

VAS reported StressBEHAVIORAL

VAS reported Stress measurement during simulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

physician anesthesiologist or anesthesia intern or nurse anesthetist or student nurse anesthetist

You may qualify if:

  • Accepts Healthy Volunteers

You may not qualify if:

  • Participants who object to the use of their data for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, 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

    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

April 25, 2022

First Posted

April 29, 2022

Study Start

May 18, 2022

Primary Completion

October 4, 2022

Study Completion

November 15, 2022

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

FR(1)