Stress, ProfessionalSimStressNCT05353621
Resilience and Acute Stress in Simulation
An observational study of Stress, Professional and Resilience, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Professional, Resilience, Anaesthesiology
- What is being tested?
- VAS reported Stress
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2022to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: physician anesthesiologist or anesthesia intern or nurse anesthetist or student nurse anesthetist
Who may be able to join
- Accepts Healthy Volunteers
Who cannot join
- Participants who object to the use of their data for research purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience and Acute Stress in Simulation : "SimStress"
The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.
Read the 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).
- Conditions
- Stress, Professional, Resilience, Anaesthesiology, Simulation
- Being tested
- VAS reported Stress
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS reported StressBehavioural
VAS reported Stress measurement during simulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%).
Measured: just Before the scenario (at 0 minute )
Secondary outcomes (6)
Performance
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.
Measured: just after the end of scenario (at 10 minute)
resilience of anesthetists
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.
Measured: 15 Days after simulation
resilience of Resident in anaesthesia
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.
Measured: 15 Days after simulation
resilience of nurse anesthetist
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.
Measured: 15 Days after simulation
resilience of the student nurse anesthetist
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.
Measured: 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%).
Measured: just after the end of scenario (at 10 minute )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start18 May 2022
- Primary completion4 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoann Zafiriou, Principal investigator, University Hospital, GrenobleJulien Picard, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353621
- Sponsor's protocol ID
- IRB 00010254 - 2022 - 052
- Acronym
- SimStress
- Status last verified
- Nov 2022
- First submitted
- 25 Apr 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience and Acute Stress in Simulation : "SimStress"
- ClinicalTrials.gov ID
- NCT05353621
- Acronym / sponsor ID
- SimStress / IRB 00010254 - 2022 - 052
- Conditions
- Stress, Professional, Resilience, Anaesthesiology, Simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- physician anesthesiologist or anesthesia intern or nurse anesthetist or student nurse anesthetist
Key inclusion criteria (1 listed)
- Accepts Healthy Volunteers
Key exclusion criteria (1 listed)
- Participants who object to the use of their data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS reported StressVAS reported Stress measurement during simulation | Behavioural | – |
Primary outcome
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.
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%).
6 secondary outcomes
Performance
Time frame: just after the end of scenario (at 10 minute)
resilience of anesthetists
Time frame: 15 Days after simulation
resilience of Resident in anaesthesia
Time frame: 15 Days after simulation
resilience of nurse anesthetist
Time frame: 15 Days after simulation
resilience of the student nurse anesthetist
Time frame: 15 Days after simulation
Self-reported stress
Time frame: just after the end of scenario (at 10 minute )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
Related trials for Stress, Professional
Active, not recruiting
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)
Burnout, Burnout, Professional
Not yet recruiting
The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers
Burnout, Professional, Stress, Psychological
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Not yet recruitingObservational study
Factors Affecting Burnout in Physiotherapists in Turkey
Burnout, Professional, Occupational Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoann Zafiriou principal investigator
University Hospital, Grenoble
Julien Picard principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Professional and Resilience, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: 15 Days after simulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.