Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training.

Study Overview
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Brief Summary
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This randomized controlled trial aims to determine if the stress response and performance of trainees who are observers in simulation training is similar to trainees who are actively participating in simulation training in the 'hotseat' during 3 consecutive simulation sessions. We hypothesize that trainees experience less stress when they are observers in the first 2 simulation sessions. However, when they are placed in the 'hotseat' during the third session, their stress response, as well as their performance, will be similar to trainees who spend all 3 simulation sessions in the 'hotseat'.

Detailed Description
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Background: High fidelity simulation-based training (SBT) using sophisticated manikins instead of real patients for medical teaching is now commonly practiced worldwide. We previously showed that SBT causes significant stress in the trainees, as evidenced by a rise in their heart rate and salivary cortisol(; and that repeated exposure to SBT was associated with the same level of stress, despite performance improving. From our studies, participants in the 'hot-seat' actively managing the clinical crisis experience the highest levels of stress but benefit the most from the learning experience. However, the stress experienced by observers (who are in the same room but not actively managing the crisis) and their learning outcomes have not been studied. Objectives: We aim to determine: 1) If observers of SBT experience less stress when compared to the trainees in the 'hot-seat' and; 2) if trainees who were observers in prior SBT sessions perform as well as trainees who were in the 'hot-seat' during subsequent SBT sessions. Methodology: Thirty-six trainee anaesthetists are randomized into 2 groups to undergo three SBT scenarios. 18 Trainees randomized to the Observer group will first undergo two SBT scenarios as observers followed by a third session in the 'hot-seat'. 18 Trainees in the Control group will undergo all 3 sessions in the 'hot seat'. For each session, stress response is measured by salivary cortisol and amylase while performance is measured using the Anaesthetists Non Technical Skills (ANTS) score. Clinical Significance: If we find that trainees who are observers of the first 2 SBT scenarios experience less stress than the 'hot-seat' trainees but yet achieve similar level of performance during the third SBT session, we can potentially make SBT less stressful and reduce the total number of simulation required, thus improving the efficiency of simulation training.

Official Title
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Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training: A Randomized Controlled Trial.

Conditions
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Stress

Intervention / Treatment
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* Other: Observer
* Other: Hotseat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anaesthesia residents in their 2nd or 3rd year of training Exclusion Criteria: Hypertension Cardiac disease Endocrine disorder Use of beta-blockers Recent stressful or traumatic life events Pregnancy

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observer<br>Trainees are in the role of observers (not actively participating in simulation scenario) during first 2 simulation sessions, then placed in the role in the 'hotseat' actively participating during the third simulation session. | Other: Observer<br>* Trainees are in the role of observers (not actively participating in simulation scenario) during first 2 simulation sessions, then placed in the role in the 'hotseat' actively participating during the third simulation session.<br>|
| Active Comparator: Hotseat<br>Trainees are in the 'hotseat' actively participating during all 3 simulation sessions | Other: Hotseat<br>* Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Cortisol from baseline | Salivary cortisol measurement. Saliva collected using Salimetric oral swabs and salivary cortisol measured using ELISA technique. | From baseline to end of the simulation session, typically after 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary amylase | Saliva collected using Salimetric oral swabs and analyzed using ELISA technique | From baseline to end of the simulation session, typically after 15 minutes. | 
| Anaesthetist's non-technical skills score | Anaesthetist's non-technical skills score: a validated and reliable marking system measuring non-technical skills comprising 4 elements including task management, teamwork, situation awareness and decision making. | During simulation, typically lasting 15 minutes. | 
| DASS questionnaire | Subject's self assessment of stress using the Depression, Anxiety and Stress questionnaire | At the end of simulation session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, performance, cortisol