<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/NCT03826069</url>
  </required_header>
  <id_info>
    <org_study_id>18-389</org_study_id>
    <nct_id>NCT03826069</nct_id>
  </id_info>
  <brief_title>Impact of Augmented Reality in Polypectomy Skills Acquisition in Simulation-based Endoscopy Training</brief_title>
  <official_title>Impact of Augmented Reality on Procedural Skills Acquisition in a Simulation-based Training Curriculum for Polypectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Simulation-based training (SBT) is a safe and effective strategy for improving skills&#xD;
      development in gastrointestinal endoscopy. The use of curricula based on progressive&#xD;
      learning, as well as comprehensive structured curricula, have been demonstrated to be&#xD;
      effective in enhancing simulation-based training. With current advancements in technologies,&#xD;
      another possible enhancement to SBT is the use of augmented reality (AR). To date, no other&#xD;
      studies have examined the benefits of AR technology in endoscopy training. This study aims to&#xD;
      evaluate the effectiveness of a simulation-based AR curriculum in developing technical&#xD;
      skills, self-assessment accuracy, and clinical performance; as compared to a conventional&#xD;
      simulation curriculum.&#xD;
&#xD;
      Thirty six novice endoscopists will be recruited from the gastroenterology and general&#xD;
      surgery programs at the University of Toronto. Participants will be randomized and assigned&#xD;
      to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of&#xD;
      simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR&#xD;
      Training Curriculum group will receive the same number of training hours and didactic&#xD;
      sessions as the control group. The main difference is the use of superimposed videos to guide&#xD;
      the intervention group through simulated polypectomy cases. During the didactic teaching&#xD;
      sessions, the intervention group will also receive a brief introduction to principles of AR&#xD;
      and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies&#xD;
      on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR®&#xD;
      virtual reality simulator. Performance will be assessed before training (pre-test),&#xD;
      immediately after training (acquisition post-test) and 4-6 weeks after training (retention&#xD;
      test). On the same day as the retention test, the participants will perform two live&#xD;
      colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by&#xD;
      two blinded expert endoscopists.&#xD;
&#xD;
      The main hypothesis of this study is that novices trained under the AR-enhanced curriculum&#xD;
      will have better technical skill performance during simulated polypectomies and live&#xD;
      colonoscopies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Simulation-based training (SBT) provides a safe and effective means to enhance skills&#xD;
      development. Simulation-based curricula have been developed for a number of minimally&#xD;
      invasive procedures, and more recently in gastrointestinal endoscopy. Previous studies have&#xD;
      demonstrated the effectiveness of comprehensive structured curricula and curricula based on&#xD;
      progressive learning in endoscopic simulation. However, as digital technologies evolve, other&#xD;
      educational strategies using the latest innovations may aid to further enhance procedural&#xD;
      skills training during simulation. One such strategy may lie in augmented reality (AR).&#xD;
&#xD;
      The use of AR involves the superimposition of a computer-generated image on a user's view of&#xD;
      the real world, which enhances the user's perception of reality. There has been a recent,&#xD;
      growing interest for the integration of AR in medical education, such as in the visualization&#xD;
      of anatomical structures, training for various medical procedures and telemedicine guidance&#xD;
      for remote procedural training. The real time interactive nature of AR provides immersion,&#xD;
      immediate learner support, and has the ability to lower the complexity of learning new tasks&#xD;
      by showing the content of the tasks using different perspectives, which is beneficial for&#xD;
      both engagement and the learning process.&#xD;
&#xD;
      To date, there are only a few studies which have investigated the application of AR for&#xD;
      medical education and procedural learning specifically. Some of the benefits demonstrated by&#xD;
      these studies include decreased amount of practice needed, reduced failure rate, improved&#xD;
      performance accuracy, accelerated learning, shortened learning curve and better understanding&#xD;
      of spatial relationships. However, the majority of studies on the application of AR have been&#xD;
      on training for laparoscopy, neurosurgical procedures, and echocardiography. There are&#xD;
      currently no studies showing the benefits of AR in endoscopy training.&#xD;
&#xD;
      Furthermore, several studies have shown the importance of self-assessment for suitable&#xD;
      lifelong learning of new techniques in minimally invasive surgery and gastrointestinal&#xD;
      endoscopy. A study by our group showed that experienced endoscopists had better&#xD;
      self-assessment accuracy compared to novice endoscopists, therefore, a targeted intervention&#xD;
      to help novice endoscopists is needed so that they may seek appropriate preceptorship during&#xD;
      their training. One such targeted intervention to improve self-assessment accuracy may be AR,&#xD;
      as it provides immediate and repeated visual support of the perfect approach to perform a&#xD;
      specific task, therefore, allowing the trainee to reflect on their performance.&#xD;
&#xD;
      In order to bridge the gap related to AR in endoscopy training, the investigators aim to&#xD;
      determine the impact of a simulation-based AR curriculum on areas such as knowledge&#xD;
      acquisition, technical performance during simulated polypectomies, non-technical skills&#xD;
      during integrated scenarios, and self-assessment accuracy. The investigators hypothesize that&#xD;
      AR is an instructional strategy with the potential to offer a highly realistic and meaningful&#xD;
      learning experience for novice endoscopists with transferable skills to clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel group, single-blinded, randomized controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Expert endoscopists will assess the performance of the participants during simulated colonoscopy, simulated polypectomies, simulated scenarios, and two live colonoscopy procedures. Assessors will have no knowledge of the group assignments and assessments will be done by viewing video recordings of the participants. The videos will be edited to remove the faces and other identifiable characteristics of the participants and patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Technical performance during simulated polypectomies</measure>
    <time_frame>The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.</time_frame>
    <description>The primary outcome measure is change in polypectomy technical performance between during the Integrated Scenario Tests and in Polypectomy Simulator Tests from pre-tests as assessed using the Direct Observation of Polypectomy Skills assessment tool (DOPyS; a validated task-specific polypectomy scoring tool) by two experienced endoscopists who will be blinded to group assignment. Range is scored from 0 to 100%; higher values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical performance during simulated and live colonoscopies</measure>
    <time_frame>The change in technical performance will be measured between a pre-test and post-test 6 weeks after the intervention.</time_frame>
    <description>Performance during simulated (pre, post, delayed) and two live clinical colonoscopies will be assessed using the Joint Advisory Group Direct Observation of Procedural Skills tool, a validated task-specific tool for performance in colonoscopy. Range is scored from 0 to 100%; higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessment of colonoscopy performance</measure>
    <time_frame>The self-assessment will be at the time of the Integrated Scenario Tests 6 weeks after the intervention.</time_frame>
    <description>Participants will be asked to assess their own colonoscopy performance using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT). This will be compared with assessor evaluations. The purpose of this outcome measure is to investigate whether augmented reality helps improve self-assessment accuracy in novice endoscopists. The GiECAT is represented as a percentage from 0-100, with higher percentage score indicating greater self-assessment of performance, a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-technical skill performance during the Integrated Scenario Test</measure>
    <time_frame>Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.</time_frame>
    <description>The non-technical skill performance will be measured using the Modified Objective Structured Assessment of Non-Technical Skills (MOSANTS) tool for colonoscopy. This is a score from 5-25, with higher scores indicating greater non-technical skill performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort during live colonoscopies</measure>
    <time_frame>This will be measured during colonoscopies performed 6 weeks after the intervention.</time_frame>
    <description>Assessed by the Nurse-Assessed Patient Comfort Score (NAPCOMS), a validated score for patient comfort in colonoscopy, ranging from 0-9, with higher scores indicating less comfort, a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>This will be measured at time of post-tests done 6 weeks after the intervention.</time_frame>
    <description>Participants will be asked to complete a questionnaire using the adapted General Self-Efficacy Scale. This validated score of self-efficacy has a scale from 4-40, with higher scores indicating higher self-efficacy (a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Load</measure>
    <time_frame>This will be measured at time of post-tests done 6 weeks after the intervention.</time_frame>
    <description>Participants will be asked to complete a questionnaire that includes the Cognitive Load Inventory for Colonoscopy (CLIC) Scale, a validated colonoscopy-specific cognitive load scale. This scale ranges from 0 to 150, with higher scores indicating greater cognitive load (a worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge acquisition</measure>
    <time_frame>This will be measured as the difference in score between pre-test and post-test, administered 6 weeks after the intervention.</time_frame>
    <description>Measured by the change in the colonoscopy-specific knowledge multiple choice test (a validated cognitive assessment tool for colonoscopy) between pre-test and post-test. This tool has been used in many prior studies in simulation in colonoscopy, is scored from 0-20 with higher scores indicating greater knowledge (a better outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Colonic Polyp</condition>
  <arm_group>
    <arm_group_label>Conventional Simulation Curriculum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four, one-hour small-group sessions on the theory of colonoscopy including pathology, anatomy, and therapeutic technique. Following each session, a multiple choice test on topics covered will be administered. In addition, this group will be given a total of six hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (5 hours). During the high-fidelity simulation, endoscopic procedures will be performed with instructor support. The difficulty of the therapeutic intervention (polypectomy) will rise after each successfully completed module. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmented Reality Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive the same 4 hours of small group teaching and 6-hours of hands-on simulator training. The intervention is the augmented reality-based curriculum: (1) a brief explanation of the principles of AR and how it will be used during the VR simulations and (2) performance of the therapeutic procedure (polypectomy) as demonstrated by the real-time AR platform. Specific videos corresponding to the therapeutic intervention and pathology (e.g pedunculated vs non-pedunculated polyp) will be available every time a polypectomy is required. Each new module will come with increased technical challenges and will require adjustment to previously used technique by the learner. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Augmented reality-based curriculum</intervention_name>
    <description>Participants in the Augmented Reality Group will be taught principles in augmented reality and training sessions will be enhanced by an augmented reality platform. This involves training on virtual reality simulators with superimposed videos and guides demonstrating correct procedure. In this study, the videos and guides will be on identifying and removing polyps.</description>
    <arm_group_label>Augmented Reality Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Simulation Curriculum</intervention_name>
    <description>Participants in this group will will train from low- to high-fidelity colonoscopy simulation. During training, the participants will receive guidance and feedback from expert endoscopists. In addition, there will be didactic sessions covering theory of colonoscopy.</description>
    <arm_group_label>Conventional Simulation Curriculum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postgraduate trainees in the gastroenterology, general surgery, or internal medicine&#xD;
             residency programs&#xD;
&#xD;
          -  Performed 25 or less live or simulated endoscopic procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performed more than 25 live or simulated endoscopic procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Grover, MD, MEd, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nikko Gimpaya, HBSc</last_name>
    <phone>416-864-5628</phone>
    <email>gimpayan@smh.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikko Gimpaya</last_name>
      <phone>4168645628</phone>
      <email>gimpayan@smh.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Augmented reality</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Polypectomy</keyword>
  <keyword>Simulation training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03826069
org study id: 18-389
nct id: NCT03826069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Simulation-based training (SBT) is a safe and effective strategy for improving skills
      development in gastrointestinal endoscopy. The use of curricula based on progressive
      learning, as well as comprehensive structured curricula, have been demonstrated to be
      effective in enhancing simulation-based training. With current advancements in technologies,
      another possible enhancement to SBT is the use of augmented reality (AR). To date, no other
      studies have examined the benefits of AR technology in endoscopy training. This study aims to
      evaluate the effectiveness of a simulation-based AR curriculum in developing technical
      skills, self-assessment accuracy, and clinical performance; as compared to a conventional
      simulation curriculum.

      Thirty six novice endoscopists will be recruited from the gastroenterology and general
      surgery programs at the University of Toronto. Participants will be randomized and assigned
      to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of
      simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR
      Training Curriculum group will receive the same number of training hours and didactic
      sessions as the control group. The main difference is the use of superimposed videos to guide
      the intervention group through simulated polypectomy cases. During the didactic teaching
      sessions, the intervention group will also receive a brief introduction to principles of AR
      and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies
      on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR®
      virtual reality simulator. Performance will be assessed before training (pre-test),
      immediately after training (acquisition post-test) and 4-6 weeks after training (retention
      test). On the same day as the retention test, the participants will perform two live
      colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by
      two blinded expert endoscopists.

      The main hypothesis of this study is that novices trained under the AR-enhanced curriculum
      will have better technical skill performance during simulated polypectomies and live
      colonoscopies.
Simulation-based training (SBT) provides a safe and effective means to enhance skills
      development. Simulation-based curricula have been developed for a number of minimally
      invasive procedures, and more recently in gastrointestinal endoscopy. Previous studies have
      demonstrated the effectiveness of comprehensive structured curricula and curricula based on
      progressive learning in endoscopic simulation. However, as digital technologies evolve, other
      educational strategies using the latest innovations may aid to further enhance procedural
      skills training during simulation. One such strategy may lie in augmented reality (AR).

      The use of AR involves the superimposition of a computer-generated image on a user's view of
      the real world, which enhances the user's perception of reality. There has been a recent,
      growing interest for the integration of AR in medical education, such as in the visualization
      of anatomical structures, training for various medical procedures and telemedicine guidance
      for remote procedural training. The real time interactive nature of AR provides immersion,
      immediate learner support, and has the ability to lower the complexity of learning new tasks
      by showing the content of the tasks using different perspectives, which is beneficial for
      both engagement and the learning process.

      To date, there are only a few studies which have investigated the application of AR for
      medical education and procedural learning specifically. Some of the benefits demonstrated by
      these studies include decreased amount of practice needed, reduced failure rate, improved
      performance accuracy, accelerated learning, shortened learning curve and better understanding
      of spatial relationships. However, the majority of studies on the application of AR have been
      on training for laparoscopy, neurosurgical procedures, and echocardiography. There are
      currently no studies showing the benefits of AR in endoscopy training.

      Furthermore, several studies have shown the importance of self-assessment for suitable
      lifelong learning of new techniques in minimally invasive surgery and gastrointestinal
      endoscopy. A study by our group showed that experienced endoscopists had better
      self-assessment accuracy compared to novice endoscopists, therefore, a targeted intervention
      to help novice endoscopists is needed so that they may seek appropriate preceptorship during
      their training. One such targeted intervention to improve self-assessment accuracy may be AR,
      as it provides immediate and repeated visual support of the perfect approach to perform a
      specific task, therefore, allowing the trainee to reflect on their performance.

      In order to bridge the gap related to AR in endoscopy training, the investigators aim to
      determine the impact of a simulation-based AR curriculum on areas such as knowledge
      acquisition, technical performance during simulated polypectomies, non-technical skills
      during integrated scenarios, and self-assessment accuracy. The investigators hypothesize that
      AR is an instructional strategy with the potential to offer a highly realistic and meaningful
      learning experience for novice endoscopists with transferable skills to clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel group, single-blinded, randomized controlled trial
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Expert endoscopists will assess the performance of the participants during simulated colonoscopy, simulated polypectomies, simulated scenarios, and two live colonoscopy procedures. Assessors will have no knowledge of the group assignments and assessments will be done by viewing video recordings of the participants. The videos will be edited to remove the faces and other identifiable characteristics of the participants and patients.
measure: Technical performance during simulated polypectomies
time frame: The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.
description: The primary outcome measure is change in polypectomy technical performance between during the Integrated Scenario Tests and in Polypectomy Simulator Tests from pre-tests as assessed using the Direct Observation of Polypectomy Skills assessment tool (DOPyS; a validated task-specific polypectomy scoring tool) by two experienced endoscopists who will be blinded to group assignment. Range is scored from 0 to 100%; higher values represent a better outcome.
measure: Technical performance during simulated and live colonoscopies
time frame: The change in technical performance will be measured between a pre-test and post-test 6 weeks after the intervention.
description: Performance during simulated (pre, post, delayed) and two live clinical colonoscopies will be assessed using the Joint Advisory Group Direct Observation of Procedural Skills tool, a validated task-specific tool for performance in colonoscopy. Range is scored from 0 to 100%; higher values represent a better outcome.
measure: Self-assessment of colonoscopy performance
time frame: The self-assessment will be at the time of the Integrated Scenario Tests 6 weeks after the intervention.
description: Participants will be asked to assess their own colonoscopy performance using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT). This will be compared with assessor evaluations. The purpose of this outcome measure is to investigate whether augmented reality helps improve self-assessment accuracy in novice endoscopists. The GiECAT is represented as a percentage from 0-100, with higher percentage score indicating greater self-assessment of performance, a better outcome.
measure: Non-technical skill performance during the Integrated Scenario Test
time frame: Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.
description: The non-technical skill performance will be measured using the Modified Objective Structured Assessment of Non-Technical Skills (MOSANTS) tool for colonoscopy. This is a score from 5-25, with higher scores indicating greater non-technical skill performance.
measure: Patient Comfort during live colonoscopies
time frame: This will be measured during colonoscopies performed 6 weeks after the intervention.
description: Assessed by the Nurse-Assessed Patient Comfort Score (NAPCOMS), a validated score for patient comfort in colonoscopy, ranging from 0-9, with higher scores indicating less comfort, a worse outcome.
measure: Self-Efficacy
time frame: This will be measured at time of post-tests done 6 weeks after the intervention.
description: Participants will be asked to complete a questionnaire using the adapted General Self-Efficacy Scale. This validated score of self-efficacy has a scale from 4-40, with higher scores indicating higher self-efficacy (a better outcome).
measure: Cognitive Load
time frame: This will be measured at time of post-tests done 6 weeks after the intervention.
description: Participants will be asked to complete a questionnaire that includes the Cognitive Load Inventory for Colonoscopy (CLIC) Scale, a validated colonoscopy-specific cognitive load scale. This scale ranges from 0 to 150, with higher scores indicating greater cognitive load (a worse outcome).
measure: Knowledge acquisition
time frame: This will be measured as the difference in score between pre-test and post-test, administered 6 weeks after the intervention.
description: Measured by the change in the colonoscopy-specific knowledge multiple choice test (a validated cognitive assessment tool for colonoscopy) between pre-test and post-test. This tool has been used in many prior studies in simulation in colonoscopy, is scored from 0-20 with higher scores indicating greater knowledge (a better outcome).
arm group label: Conventional Simulation Curriculum
arm group type: Active Comparator
description: Four, one-hour small-group sessions on the theory of colonoscopy including pathology, anatomy, and therapeutic technique. Following each session, a multiple choice test on topics covered will be administered. In addition, this group will be given a total of six hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (5 hours). During the high-fidelity simulation, endoscopic procedures will be performed with instructor support. The difficulty of the therapeutic intervention (polypectomy) will rise after each successfully completed module. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios.
arm group label: Augmented Reality Group
arm group type: Experimental
description: This group will receive the same 4 hours of small group teaching and 6-hours of hands-on simulator training. The intervention is the augmented reality-based curriculum: (1) a brief explanation of the principles of AR and how it will be used during the VR simulations and (2) performance of the therapeutic procedure (polypectomy) as demonstrated by the real-time AR platform. Specific videos corresponding to the therapeutic intervention and pathology (e.g pedunculated vs non-pedunculated polyp) will be available every time a polypectomy is required. Each new module will come with increased technical challenges and will require adjustment to previously used technique by the learner. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios.
intervention type: Other
intervention name: Augmented reality-based curriculum
description: Participants in the Augmented Reality Group will be taught principles in augmented reality and training sessions will be enhanced by an augmented reality platform. This involves training on virtual reality simulators with superimposed videos and guides demonstrating correct procedure. In this study, the videos and guides will be on identifying and removing polyps.
arm group label: Augmented Reality Group
intervention type: Other
intervention name: Conventional Simulation Curriculum
description: Participants in this group will will train from low- to high-fidelity colonoscopy simulation. During training, the participants will receive guidance and feedback from expert endoscopists. In addition, there will be didactic sessions covering theory of colonoscopy.
arm group label: Conventional Simulation Curriculum
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Samir Grover, MD, MEd, FRCPC
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Nikko Gimpaya, HBSc
phone: 416-864-5628
email: gimpayan@smh.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Colonic Polyps
sharing ipd: No