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

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02211378
Collaborator
Singhealth Foundation (Other)
33
1
2
17
1.9

Study Details

Study Description

Brief Summary

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'.

Condition or Disease Intervention/Treatment Phase
  • Other: Observer
  • Other: Hotseat
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training: A Randomized Controlled Trial.
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Salivary Cortisol from baseline [From baseline to end of the simulation session, typically after 15 minutes.]

    Salivary cortisol measurement. Saliva collected using Salimetric oral swabs and salivary cortisol measured using ELISA technique.

Secondary Outcome Measures

  1. Salivary amylase [From baseline to end of the simulation session, typically after 15 minutes.]

    Saliva collected using Salimetric oral swabs and analyzed using ELISA technique

  2. Anaesthetist's non-technical skills score [During simulation, typically lasting 15 minutes.]

    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.

  3. DASS questionnaire [At the end of simulation session]

    Subject's self assessment of stress using the Depression, Anxiety and Stress questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hospital Singapore Singapore 229899

Sponsors and Collaborators

  • KK Women's and Children's Hospital
  • Singhealth Foundation

Investigators

  • Principal Investigator: Choon L Bong, MBChB FRCA, KK Women's and Children's Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT02211378
Other Study ID Numbers:
  • CIRB2012/402/D
First Posted:
Aug 7, 2014
Last Update Posted:
Aug 7, 2014
Last Verified:
Aug 1, 2014
Keywords provided by KK Women's and Children's Hospital

Study Results

No Results Posted as of Aug 7, 2014