- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353621
Resilience and Acute Stress in Simulation (SimStress)
Resilience and Acute Stress in Simulation : "SimStress"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial will take place at the Grenoble Alpes University Hospital. Volunteer anaesthetists, nurse anaesthetists, professionals or students will perform a simulation scenario. This scenario generates a high level of stress and focuses on medication errors, which is a good educational tool for the participants.
The simulation is performed in an available operating room with a dedicated anesthesia cart. In this environment, 17 error opportunities were created, i.e., factors that could contribute to the occurrence of a medication error. A person playing the role of the anesthesiologist will give instructions, leave the room, and return to interrupt the participant several times, which will contribute to the intensity of the stressor. The simulation will proceed as follows:
Briefing:
Welcome and explanation of the session. Collection of age, gender, number of years in anesthesia, number of previous simulation sessions, participation or not in stress management training. Presentation of the context and the anesthesiologist, then the participants evaluate their stress using the VAS (visual analog scale) Stress, which triggers the beginning of the scenario. Introduction of the setting and the anesthesiologist, then participants rate their stress using the VAS Stress scale, triggering the start of the scenario.
Scenario:
10 minutes in length. After the briefing, the anesthesiologist announces the imminent arrival of a patient with a suspected abdominal aortic aneurysm. The participant must quickly prepare a tray of medications. The scenario ends just prior to the patient's arrival, with the anesthesiologist presenting the stress VAS again for further evaluation.
Debriefing:
The participant completes a questionnaire about opportunities for detected errors, followed by a 15-minute debriefing after the simulation session.
For each participant, data regarding stress VAS, CD-RISC, PSS-10 and number of errors detected will be compared.
The primary objective is to analyze an association between resilience developed by anesthesia professionals and acute stress level.
The secondary objectives are to study the association between the resilience developed by the anesthesia professionals and the level of acute stress present immediately at the end of the simulation.
immediately at the end of the simulation. Measure the association between resilience (CDRISC 10) and performance (number of potential errors detected). Compare resilience and acute stress between different statuses (anesthesiologist, intern, nurse anesthetist, student nurse anesthetist).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Grenoble, France, 38043
- University Hospital Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Accepts Healthy Volunteers
Exclusion Criteria:
- Participants who object to the use of their data for research purposes.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported stress
Time Frame: just Before the scenario (at 0 minute )
|
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%).
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just Before the scenario (at 0 minute )
|
|
Resilience
Time Frame: 15 Days after simulation
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance
Time Frame: just after the end of scenario (at 10 minute)
|
Number of potential errors detected by participants on a post-simulation questionnaire with 23 questions.
18 potential errors are present on the 23 questions.
Each correct answer counts as one point and each error removes one point.
The maximum score is 18. (performance 0-18); a higher score indicates better performance.
|
just after the end of scenario (at 10 minute)
|
|
resilience of anesthetists
Time Frame: 15 Days after simulation
|
Average measure of physician anesthesiologists' resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40).
Higher scores indicate greater resilience.
|
15 Days after simulation
|
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resilience of Resident in anaesthesia
Time Frame: 15 Days after simulation
|
Average measure of Resident in anaesthesia resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40).
Higher scores indicate greater resilience.
|
15 Days after simulation
|
|
resilience of nurse anesthetist
Time Frame: 15 Days after simulation
|
Average measure of nurse anesthetist resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40).
Higher scores indicate greater resilience.
|
15 Days after simulation
|
|
resilience of the student nurse anesthetist
Time Frame: 15 Days after simulation
|
Average measure of the student nurse anesthetist resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40).
Higher scores indicate greater resilience.
|
15 Days after simulation
|
|
Self-reported stress
Time Frame: just after the end of scenario (at 10 minute )
|
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 after the end of scenario (at 10 minute )
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien Picard, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 00010254 - 2022 - 052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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