<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/NCT04480489</url>
  </required_header>
  <id_info>
    <org_study_id>19-5565</org_study_id>
    <nct_id>NCT04480489</nct_id>
  </id_info>
  <brief_title>Testing Efficacy of VR in Medical Education</brief_title>
  <official_title>The Efficacy of Immersive 360-degree Video in Improving Spatial Orientation Among Medical Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, 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>
      Recent emergence and commercialization of immersive virtual reality (VR) shows great promise&#xD;
      in its application to medical education. While the technology is rapidly developing, we don't&#xD;
      yet know how we learn in an immersive environment. As a result, this study will investigate&#xD;
      how medical students at the University of Toronto learn from immersive 360-degree video (i.e.&#xD;
      VR) when compared to standard 2D video. The task to learn will be hospital (i.e. Toronto&#xD;
      Western Hospital) navigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recent emergence and commercialization of immersive virtual reality (VR) shows great&#xD;
      promise in its application to medical education. While several surgical, critical care, and&#xD;
      procedural 'virtual reality simulators' are described, very few immersive VR experiences that&#xD;
      use 360-degree videos have been described (Alakar et al., 2016; Zhu et al., 2014). 360-degree&#xD;
      video is a form of virtual reality that shows video content in a globe creating a sense of&#xD;
      immersion and realism that is not possible in standard 2D-videos. The videos are viewed using&#xD;
      a virtual reality headset capable of displaying the 360-degree content. Among the few studies&#xD;
      that do describe immersive learning experiences in medical training, very few have explored&#xD;
      the modality from a pedagogical perspective (Barsom et al., 2017; Cha et al, 2006). It is&#xD;
      still unclear whether learning via an immersive experience through 360-degree videos is&#xD;
      better than traditional methods such as 2D videos.&#xD;
&#xD;
      The use of traditional 2D video is quite well established in medical education as it enhances&#xD;
      knowledge transfer, communication skills, attitude formation, and appeals to learners with&#xD;
      various learning styles (Abraham et al, 2011; de Leng et al., 2007). Videos are commonly used&#xD;
      for clinical skills training as they provide standardized and consistent learning experiences&#xD;
      (Flores et al., 2010; Knowles et al., 2001). They can also be used as resources for&#xD;
      'just-in-time' learning, where students preview content by watching videos before attending&#xD;
      didactic or hands-on sessions. Patient case videos allow for rare clinical scenarios to be&#xD;
      available to students in perpetuity (Gagliano, 1988). The use of video has allowed for the&#xD;
      delivery of educational content in both asynchronous and synchronous (i.e. live or real-time)&#xD;
      formats allowing for streaming of video to distant locations with real-time dialogue at all&#xD;
      sites (Bridge et al., 2009; Gandsas et al., 2004). These advantages of video have enabled the&#xD;
      rapid expansion of some medical schools to multiple hospitals. As medical students rotate&#xD;
      through these sites during their clinical years, they often face the challenge of adjusting&#xD;
      to unfamiliar environments. Anecdotal as well as survey feedback from our site suggests that&#xD;
      unfamiliarity with a new environment induces anxiety among trainees and may result in some&#xD;
      'false' starts on the first day of the rotations. Furthermore, the unfamiliarity may cause&#xD;
      students to get lost and arrive late to their clinical assignments. Current solutions include&#xD;
      text-based directions for way-finding and orientation, which are at times are supplemented by&#xD;
      photographs and standard 2-dimensional video. The realism of 360-degree videos may provide a&#xD;
      sense of direction with better wayfinding skills because it will allow the learner to explore&#xD;
      and 'experience' the depicted location. To date, there is no study reported comparing 2D with&#xD;
      360-degree video on wayfinding and the orientation experience for medical students.&#xD;
&#xD;
      The use of video to assist with wayfinding and orientation exists but is not currently&#xD;
      reported in the literature. Spofford et al. (2012) conducted a randomized controlled trial to&#xD;
      evaluate the utility of standard lecture and 2D video in orienting students to the anesthesia&#xD;
      machine and the operating room setup. The orientation 2D video group performed significantly&#xD;
      better with higher post-test scores but scored lower on satisfaction as students preferred&#xD;
      the traditional lecture. The study did not assess the utility of orientation videos for&#xD;
      wayfinding. Furthermore, the efficacy in improving spatial orientation, reducing anxiety, or&#xD;
      enhancing the orientation process is not well known.&#xD;
&#xD;
      Hypothesis: 360-degree videos will enhance spatial orientation of medical students by:&#xD;
&#xD;
        1. Improving way-finding and sense of orientation&#xD;
&#xD;
        2. Conferring a sense of presence&#xD;
&#xD;
        3. Increasing level of satisfaction with the learning experience&#xD;
&#xD;
        4. Decreasing anxiety with a new environment&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This will be a prospective randomized controlled trial. Pre-clerkship (year 1 and 2) medical&#xD;
      students from the University of Toronto Faculty of Medicine will be recruited to take part in&#xD;
      the study. Participants will complete a baseline questionnaire collecting data quantifying&#xD;
      key potentially confounding factors such as previous 360 videos, previous visits to Toronto&#xD;
      Western Hospital, physical gait disability, and navigation experience.&#xD;
&#xD;
      Students will be randomized to two groups (see below) and given video orientation for each&#xD;
      route. It takes approximately 4 minutes to walk each one.&#xD;
&#xD;
      Route 1: Conference room 2nd floor to the Day Surgery Unit on the 4th floor. Route 2:&#xD;
      Anesthesia lounge on 2nd floor to preoperative assessment clinic on the ground floor to the&#xD;
      operating rooms on the 2nd floor&#xD;
&#xD;
      The goal of having each group complete different routes is to assess internal validity within&#xD;
      each group when given traditional vs. VR instructions. Group 1 and 2 will also be compared to&#xD;
      assess which learning method is superior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 28, 2020</start_date>
  <completion_date type="Anticipated">October 23, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2, 2020</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>Prospective randomized controlled trial. Pre-clerkship (year 1 and 2) medical students from the University of Toronto Faculty of Medicine will be recruited to take part in the study. Participants will complete a baseline questionnaire collecting data quantifying key potentially confounding factors such as previous 360 videos, previous visits to Toronto Western Hospital, physical gait disability, and navigation experience.&#xD;
A 2x2 study design will be used to implement counterbalancing as a way to control for two important sources of systematic variation in this type of study: practice and boredom effects</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time assessment</measure>
    <time_frame>End of the study (2 hours)</time_frame>
    <description>A research assistant will follow and time how long it takes the medical student to travel from the starting to end point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance assessment</measure>
    <time_frame>End of the study (2 hours)</time_frame>
    <description>The number of steps and distance travelled will be measured using a standardized pedometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of wrong turns/wrong floors/doors entered</measure>
    <time_frame>End of the study (2 hours)</time_frame>
    <description>Way finding corrective measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times student asks for help.</measure>
    <time_frame>End of the study (2 hours)</time_frame>
    <description>Way finding corrective measures</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Student measure of satisfaction</measure>
    <time_frame>End of the study (2 hours)</time_frame>
    <description>In addition to objective assessments, we will have a subjective questionnaire that participants will complete at the end of the study to indicate their comfort with spatial orientation and level of satisfaction.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Virtual Reality and Medical Education</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Group A, students will first perform Task 1 (walk from anesthesia lounge to the day surgery unit) using intervention 1 (using the virtual reality video) first, then Task 2 (walk from anesthesia lounge to the pre-operative clinic) using intervention 2 (using the traditional 2D video).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In Group B, students will first perform Task 1 (follow route 1: walk from anesthesia lounge to the day surgery unit) using intervention 2 (using the traditional 2D video) first, then Task 2 (follow route 2: walk from anesthesia lounge to the pre-operative clinic) using intervention 1 (using the virtual reality video).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR</intervention_name>
    <description>Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive VR instructions on how to navigate Route 1 (i.e. they will watch a 360-degree immersive video using Samsung VR headset).&#xD;
Task 2: After completing the Route 1 walkthrough, the same group will be given traditional instructions (2D video) on navigating Route 2, followed by an observed walkthrough of Route 2.&#xD;
Students in the arm &quot;Group A&quot; will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm &quot;Group B&quot; will perform Task 1 using Traditional video and Task 2 using VR</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional</intervention_name>
    <description>Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive traditional instructions (2D video) on how to navigate Route 1.&#xD;
Task 2: After completing the Route 1 walkthrough, the same group will be given VR instructions on how to navigate Route 2, followed by an observed walkthrough of Route 2.&#xD;
Students in the arm &quot;Group A&quot; will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm &quot;Group B&quot; will perform Task 1 using Traditional video and Task 2 using VR</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-clerkship (year 1 and 2) medical students from the University of Toronto Faculty&#xD;
             of Medicine.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical students who have had experience visiting Toronto Western Hospital for&#xD;
             personal reasons or previous coursework, shadowing, research, or clinical rotations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AHTSHAM NIAZI</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rongyu (Cindy) Jin</last_name>
    <phone>416-603-5800 Ext. 2016</phone>
    <email>rongyu.jin@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vikas Patel</last_name>
    <phone>519 702 2570</phone>
    <email>vik.patel@mail.utoronto.ca</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared to preserve student privacy and confidentiality throughout the course of the study and the feedback they share at the end of the study. The students however will be provided access to both the VR and the traditional 2D hospital orientation videos once the study is complete.</ipd_description>
  </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/NCT04480489
org study id: 19-5565
nct id: NCT04480489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recent emergence and commercialization of immersive virtual reality (VR) shows great promise
      in its application to medical education. While the technology is rapidly developing, we don't
      yet know how we learn in an immersive environment. As a result, this study will investigate
      how medical students at the University of Toronto learn from immersive 360-degree video (i.e.
      VR) when compared to standard 2D video. The task to learn will be hospital (i.e. Toronto
      Western Hospital) navigation.
The recent emergence and commercialization of immersive virtual reality (VR) shows great
      promise in its application to medical education. While several surgical, critical care, and
      procedural 'virtual reality simulators' are described, very few immersive VR experiences that
      use 360-degree videos have been described (Alakar et al., 2016; Zhu et al., 2014). 360-degree
      video is a form of virtual reality that shows video content in a globe creating a sense of
      immersion and realism that is not possible in standard 2D-videos. The videos are viewed using
      a virtual reality headset capable of displaying the 360-degree content. Among the few studies
      that do describe immersive learning experiences in medical training, very few have explored
      the modality from a pedagogical perspective (Barsom et al., 2017; Cha et al, 2006). It is
      still unclear whether learning via an immersive experience through 360-degree videos is
      better than traditional methods such as 2D videos.

      The use of traditional 2D video is quite well established in medical education as it enhances
      knowledge transfer, communication skills, attitude formation, and appeals to learners with
      various learning styles (Abraham et al, 2011; de Leng et al., 2007). Videos are commonly used
      for clinical skills training as they provide standardized and consistent learning experiences
      (Flores et al., 2010; Knowles et al., 2001). They can also be used as resources for
      'just-in-time' learning, where students preview content by watching videos before attending
      didactic or hands-on sessions. Patient case videos allow for rare clinical scenarios to be
      available to students in perpetuity (Gagliano, 1988). The use of video has allowed for the
      delivery of educational content in both asynchronous and synchronous (i.e. live or real-time)
      formats allowing for streaming of video to distant locations with real-time dialogue at all
      sites (Bridge et al., 2009; Gandsas et al., 2004). These advantages of video have enabled the
      rapid expansion of some medical schools to multiple hospitals. As medical students rotate
      through these sites during their clinical years, they often face the challenge of adjusting
      to unfamiliar environments. Anecdotal as well as survey feedback from our site suggests that
      unfamiliarity with a new environment induces anxiety among trainees and may result in some
      'false' starts on the first day of the rotations. Furthermore, the unfamiliarity may cause
      students to get lost and arrive late to their clinical assignments. Current solutions include
      text-based directions for way-finding and orientation, which are at times are supplemented by
      photographs and standard 2-dimensional video. The realism of 360-degree videos may provide a
      sense of direction with better wayfinding skills because it will allow the learner to explore
      and 'experience' the depicted location. To date, there is no study reported comparing 2D with
      360-degree video on wayfinding and the orientation experience for medical students.

      The use of video to assist with wayfinding and orientation exists but is not currently
      reported in the literature. Spofford et al. (2012) conducted a randomized controlled trial to
      evaluate the utility of standard lecture and 2D video in orienting students to the anesthesia
      machine and the operating room setup. The orientation 2D video group performed significantly
      better with higher post-test scores but scored lower on satisfaction as students preferred
      the traditional lecture. The study did not assess the utility of orientation videos for
      wayfinding. Furthermore, the efficacy in improving spatial orientation, reducing anxiety, or
      enhancing the orientation process is not well known.

      Hypothesis: 360-degree videos will enhance spatial orientation of medical students by:

        1. Improving way-finding and sense of orientation

        2. Conferring a sense of presence

        3. Increasing level of satisfaction with the learning experience

        4. Decreasing anxiety with a new environment

      Methods:

      This will be a prospective randomized controlled trial. Pre-clerkship (year 1 and 2) medical
      students from the University of Toronto Faculty of Medicine will be recruited to take part in
      the study. Participants will complete a baseline questionnaire collecting data quantifying
      key potentially confounding factors such as previous 360 videos, previous visits to Toronto
      Western Hospital, physical gait disability, and navigation experience.

      Students will be randomized to two groups (see below) and given video orientation for each
      route. It takes approximately 4 minutes to walk each one.

      Route 1: Conference room 2nd floor to the Day Surgery Unit on the 4th floor. Route 2:
      Anesthesia lounge on 2nd floor to preoperative assessment clinic on the ground floor to the
      operating rooms on the 2nd floor

      The goal of having each group complete different routes is to assess internal validity within
      each group when given traditional vs. VR instructions. Group 1 and 2 will also be compared to
      assess which learning method is superior.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized controlled trial. Pre-clerkship (year 1 and 2) medical students from the University of Toronto Faculty of Medicine will be recruited to take part in the study. Participants will complete a baseline questionnaire collecting data quantifying key potentially confounding factors such as previous 360 videos, previous visits to Toronto Western Hospital, physical gait disability, and navigation experience.
A 2x2 study design will be used to implement counterbalancing as a way to control for two important sources of systematic variation in this type of study: practice and boredom effects
primary purpose: Health Services Research
masking: None (Open Label)
measure: Time assessment
time frame: End of the study (2 hours)
description: A research assistant will follow and time how long it takes the medical student to travel from the starting to end point.
measure: Distance assessment
time frame: End of the study (2 hours)
description: The number of steps and distance travelled will be measured using a standardized pedometer.
measure: Number of wrong turns/wrong floors/doors entered
time frame: End of the study (2 hours)
description: Way finding corrective measures
measure: Number of times student asks for help.
time frame: End of the study (2 hours)
description: Way finding corrective measures
measure: Student measure of satisfaction
time frame: End of the study (2 hours)
description: In addition to objective assessments, we will have a subjective questionnaire that participants will complete at the end of the study to indicate their comfort with spatial orientation and level of satisfaction.
arm group label: Group A
arm group type: Experimental
description: In Group A, students will first perform Task 1 (walk from anesthesia lounge to the day surgery unit) using intervention 1 (using the virtual reality video) first, then Task 2 (walk from anesthesia lounge to the pre-operative clinic) using intervention 2 (using the traditional 2D video).
arm group label: group B
arm group type: Active Comparator
description: In Group B, students will first perform Task 1 (follow route 1: walk from anesthesia lounge to the day surgery unit) using intervention 2 (using the traditional 2D video) first, then Task 2 (follow route 2: walk from anesthesia lounge to the pre-operative clinic) using intervention 1 (using the virtual reality video).
intervention type: Other
intervention name: VR
description: Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive VR instructions on how to navigate Route 1 (i.e. they will watch a 360-degree immersive video using Samsung VR headset).
Task 2: After completing the Route 1 walkthrough, the same group will be given traditional instructions (2D video) on navigating Route 2, followed by an observed walkthrough of Route 2.
Students in the arm "Group A" will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm "Group B" will perform Task 1 using Traditional video and Task 2 using VR
arm group label: Group A
arm group label: group B
intervention type: Other
intervention name: Traditional
description: Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive traditional instructions (2D video) on how to navigate Route 1.
Task 2: After completing the Route 1 walkthrough, the same group will be given VR instructions on how to navigate Route 2, followed by an observed walkthrough of Route 2.
Students in the arm "Group A" will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm "Group B" will perform Task 1 using Traditional video and Task 2 using VR
arm group label: Group A
arm group label: group B
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: AHTSHAM NIAZI
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Rongyu (Cindy) Jin
phone: 416-603-5800 Ext. 2016
email: rongyu.jin@uhn.ca
last name: Vikas Patel
phone: 519 702 2570
email: vik.patel@mail.utoronto.ca
responsible party type: Sponsor
sharing ipd: No
ipd description: Individual participant data will not be shared to preserve student privacy and confidentiality throughout the course of the study and the feedback they share at the end of the study. The students however will be provided access to both the VR and the traditional 2D hospital orientation videos once the study is complete.