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Completed

NCT Number: NCT03441425

Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions

Some educational researchers deliberately induce stress upon learners to in order to enhance retention; this practice is controversial and its utility must be weighed against the negative emotional effects it may have on participants. In this study we investigate the effect of the unexpected death of a simulation mannequin on the retention of non-technical and technical crisis resource management skills and consider the emotional impact of this acute stressor.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital, Ottawa, Ontario, Canada

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About this study

Background High-fidelity simulation is an increasingly used teaching tool that is proven to be effective for learning. According to the literature, by gradually increasing stress and emotions, more effective learning can be achieved. However, allowing the simulated patient to "die", as a deliberate stressor, is controversial. There is no previous research on the educational effect of letting a simulated patient die. We aim to evaluate the effects of simulated unexpected death on skill retention, stress levels, and emotions. We hypothesize that the occurrence of unexpected death will impact skill retention, and will be associated with higher stress levels and stronger emotions.

Methods After Institutional Research Ethics Board approval, 56 residents and fellows of different medical specialties will be randomized to either the intervention (unexpected death) or control (survive) group. Participants from both groups will have to individually manage a simulated cardiac arrest crisis. In the intervention group, the scenario will end by the death of the simulated patient, whilst in the control group the simulated patient will survive. Each participant will be immediately debriefed by a trained instructor. Three months later, skill retention will be assessed in a similar scenario. Crisis management performance of all scenarios will be rated by 2 blinded raters. Biological stress, cognitive appraisal, and emotions will be measured during both scenarios.

Implications The impact of simulated unexpected death on skill retention of residents and fellows will provide instructors with evidence to optimize scenario design and approach the role of stress and emotions in simulation-based education.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be a resident or a fellow in the department of anesthesiology, critical care, emergency medicine, medicine, obstetrics and gynecology, surgery or family medicine at the University of Ottawa or the University of Toronto
  • Participants are requested to refrain from physical strains, smoking, drinking caffeinated or low pH beverages and eating for at least one hour before enrollment
  • Participants will be included between 11 AM and 8 PM, when cortisol levels are most stable

Exclusion criteria

  • Not a resident or fellow in one of the departments indicated above

Treatment and study plan

Unexpected death

Other

Primary outcomes

  1. Non-technical Crisis Resource Management (CRM) skills

    Time frame: 3 months

    Assessed using the Ottawa Global Rating Scale

Secondary outcomes

  1. Technical CRM skills

    Time frame: 3 months

    Assessed using a checklist derived from the American Heart Association's Megacode Checklist

  2. Salivary cortisol

    Time frame: 5 time points during each of the 2 simulation days

    Biomarker of stress

  3. State-trait anxiety inventory

    Time frame: 3 time points during each of the 2 simulation days

    Self-perceived anxiety questionnaire

  4. Cognitive appraisal

    Time frame: 2 time points during each of the 2 simulation days

    Ratio of perceived preparedness versus demands of a task

  5. Positive and Negative Affect Schedule (PANAS)

    Time frame: 1 time point during each of the 2 simulation days

    Classification of emotions experienced

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Mar 24, 2020

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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