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Completed

NCT Number: NCT02211378

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

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'.

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Key information

Conditions

Age range

24 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observer

Other

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.

Hotseat

Other

Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Singhealth Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2014
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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