ResilienceNCT05863533
Resilience, Performance and Stress in Anaesthesia
An observational study of Resilience and Stress, Psychological, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study was to determine whether there was an association between resilience and the performance of student nurse anaesthetists in simulated critical situations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience, Stress, Psychological
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2023to 1 Sep 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nurse in the first or second year of specialisation as a nurse anaesthetist.
Who may be able to join
- Voluntary first or second year nurse anaesthetist student
Who cannot join
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study
The aim of this study was to determine whether there was an association between resilience and the performance of student nurse anaesthetists in simulated critical situations.
Read the detailed description
This trial will take place at the Grenoble Alpes University Hospital. Volunteer nurse anaesthetists students will perform a simulation scenario. This scenario generates a high level of stress and focuses on the management of anaphylactic shock in the operating room, which is a good teaching tool for the participants.
The simulation is performed in a dedicated simulation room configured as an operating theatre. In this environment, a high-fidelity manikin is intubated and ventilated on an anaesthesia ventilator. The manikin is perfused. The anaesthesia cart is replicated with the same equipment and drugs as the anaesthesia carts in the operating theatre. A person playing the role of a nurse anaesthetist will conduct transmissions before leaving the room replaced by the participant. One person will play the role of the surgeon in the room. The simulation will take place as follows:
Briefing :
Welcome and explanation of the session. Collection of age, gender, number of years in anaesthesia, number of years as a nurse.
The simulation room, the mannequin and the anaesthesia trolley are presented by a simulation trainer before starting the scenario.
First evaluation of the acute stress perceived by the VAS stress(visual analogue stress scale) which triggers the beginning of the scenario.
The patient is introduced by the nurse anaesthetist present in the room and explanations are given on how to reach the anaesthetist by phone. Once the transmissions are completed, the preoperative checklist is carried out by the surgeon with the nurse anaesthetist and the student nurse anaesthetist who takes over. Once the checklist is completed the simulation timer is started and the nurse anaesthetist leaves the room leaving the patient alone on the anaesthesia side.
Scenario:
On arrival at the room:
→ Vitals on arrival: BP (blood pressure)= 100/50, HR(heart rate) = 60, Spo2 = 99%, EtC02 (end tidal C02) = 36 mmHg
T0: Surgical incision
→ Vitals at incision: BP = 120/70, HR = 70, SpO2 = 99%, EtCo2 = 39 mmHg
T1 = 3 min: BP = 90/55, HR = 95, SpO2 = 98%, EtCo2 = 34 mmHg
T2 = 6 min: BP = 78/45, HR = 110, SpO2 = 97%, EtCo2 = 30 mmHg, if possible: vary the SpO2 signal if possible
T3 = 9 min: BP = 65/32, HR = 130, SpO2 = no signal, EtCO2 = 28 mmHg
T4 = 12 min: BP = 56/28, HR = 150, SpO2 = no signal, EtCO2 = 25 mmHg
If no communication with the surgical team before T3, the facilitating surgeon mentions a skin rash to guide management.
The study stops at 12 minutes when the anaesthetist enters the operating room.
Debriefing: The debriefing is conducted by a simulation trainer accordance with the guidelines of the French Society of Health Simulation.
The main objective of this study is to investigate an association between the level of resilience of student nurse anaesthetists and their performance (Performance score N°1) under stress.
The secondary objectives of this study are to investigate the correlation between :
- Performance score N°2 (without taking into account the notion of time in scale N°1) and resilience by ConnorDavison Resilience scale (CDRISC 10).
- Work experience and performance score 1
- Years of specialisation in anesthesia and Performance score 1
- Age and performance score 1
- Conditions
- Resilience, Stress, Psychological
- Keywords
- Resilience, Acute stress, Performance, Anaesthetist student, Simulation
- Medical subject headings
- Stress, Psychological
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: at Day 0 : 10 minutes before simulation
Secondary outcomes (5)
Performance score 1
Performance scale with 15 items based on the recommendations for the management of anaphylactic shock by the French Society of Anaesthesia and Intensive Care. The time taken to perform the procedure is noted and influences the score. The final score ranges from 0 to 60 points. A higher score indicates a higher performance.
Measured: at Day 0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes))
Performance score 2
Performance scale with 15 items based on the recommendations for the management of anaphylactic shock by the French Society of Anaesthesia and Intensive Care. The final score ranges from 0 to 15 points. A higher score indicates a higher performance.
Measured: at D0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes)
Age of anaesthesia professionals
Age of anesthesia professionals: (quantitative variable)
Measured: at Day 0 : 10 minutes before simulation
work experience
number of years since first nursing practice (quantitative variable)
Measured: at Day 0 : 10 minutes before simulation
year of specialisation
Year of specialisation : first year or second year(qualitative variable)
Measured: at Day 0 : 10 minutes before simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 May 2023
- Primary completion15 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Picard, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863533
- Sponsor's protocol ID
- IRB 00010254 - 2023 - 030
- Status last verified
- Dec 2023
- First submitted
- 3 May 2023
- Last updated
- 5 Dec 2023
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study
- ClinicalTrials.gov ID
- NCT05863533
- Acronym / sponsor ID
- IRB 00010254 - 2023 - 030
- Conditions
- Resilience, Stress, Psychological
- Keywords
- Resilience, Acute stress, Performance, Anaesthetist student, Simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 18 May 2023 (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 aim of this study was to determine whether there was an association between resilience and the performance of student nurse anaesthetists in simulated critical situations.
Detailed description
This trial will take place at the Grenoble Alpes University Hospital. Volunteer nurse anaesthetists students will perform a simulation scenario. This scenario generates a high level of stress and focuses on the management of anaphylactic shock in the operating room, which is a good teaching tool for the participants.
The simulation is performed in a dedicated simulation room configured as an operating theatre. In this environment, a high-fidelity manikin is intubated and ventilated on an anaesthesia ventilator. The manikin is perfused. The anaesthesia cart is replicated with the same equipment and drugs as the anaesthesia carts in the operating theatre. A person playing the role of a nurse anaesthetist will conduct transmissions before leaving the room replaced by the participant. One person will play the role of the surgeon in the room. The simulation will take place as follows:
Briefing :
Welcome and explanation of the session. Collection of age, gender, number of years in anaesthesia, number of years as a nurse.
The simulation room, the mannequin and the anaesthesia trolley are presented by a simulation trainer before starting the scenario.
First evaluation of the acute stress perceived by the VAS stress(visual analogue stress scale) which triggers the beginning of the scenario.
The patient is introduced by the nurse anaesthetist present in the room and explanations are given on how to reach the anaesthetist by phone. Once the transmissions are completed, the preoperative checklist is carried out by the surgeon with the nurse anaesthetist and the student nurse anaesthetist who takes over. Once the checklist is completed the simulation timer is started and the nurse anaesthetist leaves the room leaving the patient alone on the anaesthesia side.
Scenario:
On arrival at the room:
→ Vitals on arrival: BP (blood pressure)= 100/50, HR(heart rate) = 60, Spo2 = 99%, EtC02 (end tidal C02) = 36 mmHg
T0: Surgical incision
→ Vitals at incision: BP = 120/70, HR = 70, SpO2 = 99%, EtCo2 = 39 mmHg
T1 = 3 min: BP = 90/55, HR = 95, SpO2 = 98%, EtCo2 = 34 mmHg
T2 = 6 min: BP = 78/45, HR = 110, SpO2 = 97%, EtCo2 = 30 mmHg, if possible: vary the SpO2 signal if possible
T3 = 9 min: BP = 65/32, HR = 130, SpO2 = no signal, EtCO2 = 28 mmHg
T4 = 12 min: BP = 56/28, HR = 150, SpO2 = no signal, EtCO2 = 25 mmHg
If no communication with the surgical team before T3, the facilitating surgeon mentions a skin rash to guide management.
The study stops at 12 minutes when the anaesthetist enters the operating room.
Debriefing: The debriefing is conducted by a simulation trainer accordance with the guidelines of the French Society of Health Simulation.
The main objective of this study is to investigate an association between the level of resilience of student nurse anaesthetists and their performance (Performance score N°1) under stress.
The secondary objectives of this study are to investigate the correlation between :
- Performance score N°2 (without taking into account the notion of time in scale N°1) and resilience by ConnorDavison Resilience scale (CDRISC 10).
- Work experience and performance score 1
- Years of specialisation in anesthesia and Performance score 1
- Age and performance score 1
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nurse in the first or second year of specialisation as a nurse anaesthetist.
Key inclusion criteria (1 listed)
- Voluntary first or second year nurse anaesthetist student
Key exclusion criteria (1 listed)
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience
Time frame: at Day 0 : 10 minutes before 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.
5 secondary outcomes
Performance score 1
Time frame: at Day 0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes))
Performance score 2
Time frame: at D0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes)
Age of anaesthesia professionals
Time frame: at Day 0 : 10 minutes before simulation
work experience
Time frame: at Day 0 : 10 minutes before simulation
year of specialisation
Time frame: at Day 0 : 10 minutes before simulation
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 5 Dec 2023.
Related trials for Resilience
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Recruiting
A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
Burnout, Healthcare Workers, Breathing Exercises
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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.
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 Resilience and Stress, Psychological, 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 5 Dec 2023. 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: at Day 0 : 10 minutes before simulation). 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 5 Dec 2023.