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

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

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'.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Other: Observer; Other: Hotseat

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Observer; 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; 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.
Active Comparator: Hotseat; Trainees are in the 'hotseat' actively participating during all 3 simulation sessions	Other: Hotseat; Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Singhealth Foundation
• Investigators: Principal Investigator: Choon L Bong, MBChB FRCA, KK Women's and Children's Hospital, Singapore

Publications and helpful links

General Publications

• Bong CL, Lightdale JR, Fredette ME, Weinstock P. Effects of simulation versus traditional tutorial-based training on physiologic stress levels among clinicians: a pilot study. Simul Healthc. 2010 Oct;5(5):272-8. doi: 10.1097/SIH.0b013e3181e98b29.
• Bong CL, Lee S, Ng ASB, Allen JC, Lim EHL, Vidyarthi A. The effects of active (hot-seat) versus observer roles during simulation-based training on stress levels and non-technical performance: a randomized trial. Adv Simul (Lond). 2017 Mar 20;2:7. doi: 10.1186/s41077-017-0040-7. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: stress; cortisol; performance
• Other Study ID Numbers: CIRB2012/402/D