NCT02211378

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

August 5, 2014

Last Update Submit

August 6, 2014

Conditions

Stress

Keywords

stressperformancecortisol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Salivary amylase

    From baseline to end of the simulation session, typically after 15 minutes.

  • Anaesthetist's non-technical skills score

    During simulation, typically lasting 15 minutes.

  • DASS questionnaire

    At the end of simulation session

Study Arms (2)

Observer

EXPERIMENTAL

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

Hotseat

ACTIVE COMPARATOR

Trainees are in the 'hotseat' actively participating during all 3 simulation sessions

Other: Hotseat

Interventions

ObserverOTHER

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.

Observer
HotseatOTHER

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

Hotseat

Eligibility Criteria

Age24 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Anaesthesia residents in their 2nd or 3rd year of training

You may not qualify if:

  • Hypertension
  • Cardiac disease
  • Endocrine disorder
  • Use of beta-blockers
  • Recent stressful or traumatic life events
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 21330809BACKGROUND

  • 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.

    PMID: 29450008DERIVED

MeSH Terms

Interventions

Observer Variation

Intervention Hierarchy (Ancestors)

Diagnostic ErrorsDiagnosisMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesBiasEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Choon L Bong, MBChB FRCA

    KK Women's and Children's Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

SG(1)