<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/NCT04425499</url>
  </required_header>
  <id_info>
    <org_study_id>CERSES 20-068-D</org_study_id>
    <nct_id>NCT04425499</nct_id>
  </id_info>
  <brief_title>A Gamified Network for Surgical Education During COVID-19: A Randomized Controlled Trial</brief_title>
  <official_title>A Gamified Network for Surgical Education During COVID-19: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Montréal</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>
      Background: Traditionally, medical students learn surgical skills through the observation of&#xD;
      a resident or a surgeon performing the technique. Due to inconsistent practice opportunities&#xD;
      in the clinical setting, a disparity of skill levels among students has been observed. In&#xD;
      addition, the poor availability of faculty professors is a limiting factor in teaching and&#xD;
      adequately preparing medical students for clerkship years. With the ongoing COVID-19&#xD;
      pandemic, medical students do not have access to traditional suturing learning opportunities.&#xD;
      Didactic courses are available on videoconferencing platforms, but they do not include&#xD;
      technical training.&#xD;
&#xD;
      Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for&#xD;
      advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use&#xD;
      GEN (Gamified Educational Network), a newly developed online learning tool. The investigators&#xD;
      will assess students' ability to identify and to perform the right technique. The&#xD;
      investigators will also assess students' satisfaction with regards to GEN.&#xD;
&#xD;
      Methods: The investigators will conduct a prospective randomized controlled trial with&#xD;
      blinding of expert examiners. First-year medical students in the Faculty of Medicine of&#xD;
      Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning,&#xD;
      3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15&#xD;
      participants who will learn how to perform running subcuticular sutures through videos on&#xD;
      GEN. For our primary outcome, students' ability to identify the right technique will be&#xD;
      evaluated before and after the intervention on GEN. They will view eight videos and rate the&#xD;
      surgical technique using the OSATS (Objective Structured Assessment of Technical Skills)&#xD;
      Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For&#xD;
      our secondary outcomes, students will anonymously record themselves performing a running&#xD;
      subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent&#xD;
      to analyze the overall performance of the platform.&#xD;
&#xD;
      Results: The study will be conducted in accordance with the Declaration of Helsinki and has&#xD;
      been approved by our institutional review board (CERSES 20-068-D). No participants have been&#xD;
      recruited yet.&#xD;
&#xD;
      Conclusions: Peer-learning through GEN has the potential to overcome significant limitations&#xD;
      related to the pandemic and the lack of availability of faculty professors. Further, a&#xD;
      decrease of the anxiety related to traditional suturing classes can be expected. The&#xD;
      investigators aim to create an innovative and sustainable method of teaching surgical skills&#xD;
      to improve the efficiency and the quality of surgical training in medical faculties. With the&#xD;
      current world events of COVID-19, the necessity for such tools are imperative.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention of the correct technique for running subcuticular sutures</measure>
    <time_frame>three days</time_frame>
    <description>The Global Rating Scale and Subcuticular Suture Checklist will be used to measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical ability to perform a subcuticular suture</measure>
    <time_frame>half a day</time_frame>
    <description>The Global Rating Scale and Subcuticular Suture Checklist will be used to assess students' skills</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the GEN platform</measure>
    <time_frame>five minutes</time_frame>
    <description>A survey will be sent to students</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Advanced Suturing Skills</condition>
  <condition>Surgical Education</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>On GEN (Gamified Educational Network), each student will view individually eight videos of an expert performing a running subcuticular suture correctly. The OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and Subcuticular Suture Checklist will be available beside each video and students will be required to fill them out for each video. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, students will view the same eight videos of an expert performing a running subcuticular suture, however, the videos will be shuffled in a different order. The order of the videos will be the same for all students.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each student will view eight videos individually and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. The errors will be technical mistakes in the execution of a running subcuticular suture. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, all students will repeat this activity. However, the same videos will be shuffled in a different order. The order of the videos will be the same for all students.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer-learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each student will view eight videos and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. After this initial test, students will interact with other medical students in their group on the GEN platform anonymously for three days. We will display distinct videos on GEN. Comments will be allowed in an interactive way to encourage exchanges. Students will be required to participate in the discussion of at least two videos. Students will not be able to modify their answers on the initial test. On the third day, students in this group will perform a post-test individually with the same eight initial videos but shuffled. The order of the videos will be the same for all students.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer-learning with expert feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as group 3, the only difference is that an expert will actively participate in the discussion by commenting on each video on GEN, enhancing students' educational experience. Although anonymous, students will be able to identify the expert as the name &quot;expert&quot; will be used. The expert will answer any question and comment on the discussion in order to guide the students.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Learning running subcuticular sutures on the Gamified Educational Network</intervention_name>
    <description>Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Peer-learning</arm_group_label>
    <arm_group_label>Peer-learning with expert feedback</arm_group_label>
    <arm_group_label>Self-learning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students must be enrolled in their first year of medical school at Université de&#xD;
             Montréal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who have returned after a leave such as a sabbatical year/sick&#xD;
             leave/maternity leave.&#xD;
&#xD;
          -  Students who have already obtained a medical degree in another country.&#xD;
&#xD;
          -  Students who studied medicine in another country.&#xD;
&#xD;
          -  Any student injured at the beginning of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Érica Patocskai</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Running subcuticular sutures</keyword>
  <keyword>Surgical education</keyword>
  <keyword>Advanced suturing skills</keyword>
  <keyword>Distant learning</keyword>
  <keyword>Peer-learning</keyword>
  <keyword>Network</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/NCT04425499
org study id: CERSES 20-068-D
nct id: NCT04425499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Traditionally, medical students learn surgical skills through the observation of
      a resident or a surgeon performing the technique. Due to inconsistent practice opportunities
      in the clinical setting, a disparity of skill levels among students has been observed. In
      addition, the poor availability of faculty professors is a limiting factor in teaching and
      adequately preparing medical students for clerkship years. With the ongoing COVID-19
      pandemic, medical students do not have access to traditional suturing learning opportunities.
      Didactic courses are available on videoconferencing platforms, but they do not include
      technical training.

      Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for
      advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use
      GEN (Gamified Educational Network), a newly developed online learning tool. The investigators
      will assess students' ability to identify and to perform the right technique. The
      investigators will also assess students' satisfaction with regards to GEN.

      Methods: The investigators will conduct a prospective randomized controlled trial with
      blinding of expert examiners. First-year medical students in the Faculty of Medicine of
      Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning,
      3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15
      participants who will learn how to perform running subcuticular sutures through videos on
      GEN. For our primary outcome, students' ability to identify the right technique will be
      evaluated before and after the intervention on GEN. They will view eight videos and rate the
      surgical technique using the OSATS (Objective Structured Assessment of Technical Skills)
      Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For
      our secondary outcomes, students will anonymously record themselves performing a running
      subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent
      to analyze the overall performance of the platform.

      Results: The study will be conducted in accordance with the Declaration of Helsinki and has
      been approved by our institutional review board (CERSES 20-068-D). No participants have been
      recruited yet.

      Conclusions: Peer-learning through GEN has the potential to overcome significant limitations
      related to the pandemic and the lack of availability of faculty professors. Further, a
      decrease of the anxiety related to traditional suturing classes can be expected. The
      investigators aim to create an innovative and sustainable method of teaching surgical skills
      to improve the efficiency and the quality of surgical training in medical faculties. With the
      current world events of COVID-19, the necessity for such tools are imperative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Retention of the correct technique for running subcuticular sutures
time frame: three days
description: The Global Rating Scale and Subcuticular Suture Checklist will be used to measure
measure: Technical ability to perform a subcuticular suture
time frame: half a day
description: The Global Rating Scale and Subcuticular Suture Checklist will be used to assess students' skills
measure: Satisfaction with the GEN platform
time frame: five minutes
description: A survey will be sent to students
arm group label: Control group
arm group type: Placebo Comparator
description: On GEN (Gamified Educational Network), each student will view individually eight videos of an expert performing a running subcuticular suture correctly. The OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and Subcuticular Suture Checklist will be available beside each video and students will be required to fill them out for each video. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, students will view the same eight videos of an expert performing a running subcuticular suture, however, the videos will be shuffled in a different order. The order of the videos will be the same for all students.
arm group label: Self-learning
arm group type: Experimental
description: Each student will view eight videos individually and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. The errors will be technical mistakes in the execution of a running subcuticular suture. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, all students will repeat this activity. However, the same videos will be shuffled in a different order. The order of the videos will be the same for all students.
arm group label: Peer-learning
arm group type: Experimental
description: Each student will view eight videos and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. After this initial test, students will interact with other medical students in their group on the GEN platform anonymously for three days. We will display distinct videos on GEN. Comments will be allowed in an interactive way to encourage exchanges. Students will be required to participate in the discussion of at least two videos. Students will not be able to modify their answers on the initial test. On the third day, students in this group will perform a post-test individually with the same eight initial videos but shuffled. The order of the videos will be the same for all students.
arm group label: Peer-learning with expert feedback
arm group type: Experimental
description: Same as group 3, the only difference is that an expert will actively participate in the discussion by commenting on each video on GEN, enhancing students' educational experience. Although anonymous, students will be able to identify the expert as the name "expert" will be used. The expert will answer any question and comment on the discussion in order to guide the students.
intervention type: Other
intervention name: Learning running subcuticular sutures on the Gamified Educational Network
description: Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN.
arm group label: Control group
arm group label: Peer-learning
arm group label: Peer-learning with expert feedback
arm group label: Self-learning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Érica Patocskai
investigator title: Assistant professor