<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02211378</url>
  </required_header>
  <id_info>
    <org_study_id>CIRB2012/402/D</org_study_id>
    <nct_id>NCT02211378</nct_id>
  </id_info>
  <brief_title>Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training.</brief_title>
  <official_title>Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Singhealth Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KK Women's and Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial aims to determine if the stress response and performance of&#xD;
      trainees who are observers in simulation training is similar to trainees who are actively&#xD;
      participating in simulation training in the 'hotseat' during 3 consecutive simulation&#xD;
      sessions.&#xD;
&#xD;
      We hypothesize that trainees experience less stress when they are observers in the first 2&#xD;
      simulation sessions. However, when they are placed in the 'hotseat' during the third session,&#xD;
      their stress response, as well as their performance, will be similar to trainees who spend&#xD;
      all 3 simulation sessions in the 'hotseat'.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: High fidelity simulation-based training (SBT) using sophisticated manikins&#xD;
      instead of real patients for medical teaching is now commonly practiced worldwide. We&#xD;
      previously showed that SBT causes significant stress in the trainees, as evidenced by a rise&#xD;
      in their heart rate and salivary cortisol(; and that repeated exposure to SBT was associated&#xD;
      with the same level of stress, despite performance improving. From our studies, participants&#xD;
      in the 'hot-seat' actively managing the clinical crisis experience the highest levels of&#xD;
      stress but benefit the most from the learning experience. However, the stress experienced by&#xD;
      observers (who are in the same room but not actively managing the crisis) and their learning&#xD;
      outcomes have not been studied.&#xD;
&#xD;
      Objectives: We aim to determine: 1) If observers of SBT experience less stress when compared&#xD;
      to the trainees in the 'hot-seat' and; 2) if trainees who were observers in prior SBT&#xD;
      sessions perform as well as trainees who were in the 'hot-seat' during subsequent SBT&#xD;
      sessions.&#xD;
&#xD;
      Methodology: Thirty-six trainee anaesthetists are randomized into 2 groups to undergo three&#xD;
      SBT scenarios. 18 Trainees randomized to the Observer group will first undergo two SBT&#xD;
      scenarios as observers followed by a third session in the 'hot-seat'. 18 Trainees in the&#xD;
      Control group will undergo all 3 sessions in the 'hot seat'. For each session, stress&#xD;
      response is measured by salivary cortisol and amylase while performance is measured using the&#xD;
      Anaesthetists Non Technical Skills (ANTS) score.&#xD;
&#xD;
      Clinical Significance: If we find that trainees who are observers of the first 2 SBT&#xD;
      scenarios experience less stress than the 'hot-seat' trainees but yet achieve similar level&#xD;
      of performance during the third SBT session, we can potentially make SBT less stressful and&#xD;
      reduce the total number of simulation required, thus improving the efficiency of simulation&#xD;
      training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Salivary Cortisol from baseline</measure>
    <time_frame>From baseline to end of the simulation session, typically after 15 minutes.</time_frame>
    <description>Salivary cortisol measurement. Saliva collected using Salimetric oral swabs and salivary cortisol measured using ELISA technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary amylase</measure>
    <time_frame>From baseline to end of the simulation session, typically after 15 minutes.</time_frame>
    <description>Saliva collected using Salimetric oral swabs and analyzed using ELISA technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaesthetist's non-technical skills score</measure>
    <time_frame>During simulation, typically lasting 15 minutes.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASS questionnaire</measure>
    <time_frame>At the end of simulation session</time_frame>
    <description>Subject's self assessment of stress using the Depression, Anxiety and Stress questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Observer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hotseat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trainees are in the 'hotseat' actively participating during all 3 simulation sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observer</intervention_name>
    <description>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.</description>
    <arm_group_label>Observer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hotseat</intervention_name>
    <description>Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.</description>
    <arm_group_label>Hotseat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anaesthesia residents in their 2nd or 3rd year of training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Cardiac disease&#xD;
&#xD;
          -  Endocrine disorder&#xD;
&#xD;
          -  Use of beta-blockers&#xD;
&#xD;
          -  Recent stressful or traumatic life events&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Choon L Bong, MBChB FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21330809</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stress</keyword>
  <keyword>performance</keyword>
  <keyword>cortisol</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211378
org study id: CIRB2012/402/D
nct id: NCT02211378
lead sponsor: 
collaborator: 
has dmc: No
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'.
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.
allocation: Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Change in Salivary Cortisol from baseline
time frame: From baseline to end of the simulation session, typically after 15 minutes.
description: Salivary cortisol measurement. Saliva collected using Salimetric oral swabs and salivary cortisol measured using ELISA technique.
measure: Salivary amylase
time frame: From baseline to end of the simulation session, typically after 15 minutes.
description: Saliva collected using Salimetric oral swabs and analyzed using ELISA technique
measure: Anaesthetist's non-technical skills score
time frame: During simulation, typically lasting 15 minutes.
description: 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.
measure: DASS questionnaire
time frame: At the end of simulation session
description: Subject's self assessment of stress using the Depression, Anxiety and Stress questionnaire
arm group label: Observer
arm group type: Experimental
description: 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.
arm group label: Hotseat
arm group type: Active Comparator
description: Trainees are in the 'hotseat' actively participating during all 3 simulation sessions
intervention type: Other
intervention name: Observer
description: 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.
arm group label: Observer
intervention type: Other
intervention name: Hotseat
description: Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.
arm group label: Hotseat
criteria: 
gender: All
minimum age: 24 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Choon L Bong, MBChB FRCA
role: Principal Investigator
affiliation: KK Women's and Children's Hospital, Singapore
facility: 
country: Singapore
citation: 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: 21330809
responsible party type: Sponsor