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

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ClinicalTrials.gov Identifier: NCT02211378
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Collaborator:
Singhealth Foundation
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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
Stress Other: Observer Other: Hotseat Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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.




Primary Outcome Measures :
  1. Change in Salivary Cortisol from baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the end of simulation session ]
    Subject's self assessment of stress using the Depression, Anxiety and Stress questionnaire



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Ages Eligible for Study:   24 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211378


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Singhealth Foundation
Investigators
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Principal Investigator: Choon L Bong, MBChB FRCA KK Women's and Children's Hospital, Singapore

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02211378     History of Changes
Other Study ID Numbers: CIRB2012/402/D
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by KK Women's and Children's Hospital:
stress
performance
cortisol