<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/NCT02971735</url>
  </required_header>
  <id_info>
    <org_study_id>105-5290C</org_study_id>
    <nct_id>NCT02971735</nct_id>
  </id_info>
  <brief_title>Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education</brief_title>
  <official_title>Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education- A Randomized Controlled Trial of Otolaryngology-head and Neck Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      New designs of 6-year undergraduate medical education (UME) in Taiwan mainly include (1)&#xD;
      integral curricula of body organ system, (2) multiple methods of clinical teaching and&#xD;
      assessment, and (3) generalism in UME. Accompany with decreasing educational hours in the&#xD;
      classrooms and hospital, essential but minor components of primary healthcare such as&#xD;
      ophthalmology and otolaryngology-head and neck surgery (ORL-HNS) is disproportionately&#xD;
      under-represented in UME. Novel medical education stresses on enabling self-directory&#xD;
      learning and increasing learning hours outside the classrooms. Accordingly, we hypothesize&#xD;
      that innovations in educational technology can enhance the learning outcomes of ORL-HNS. This&#xD;
      study is aimed to determine whether mobile technology in e-learning (M-TEL) is an effective&#xD;
      tool for the instruction of ORL-HNS and to compare effects of different cognitive styles on&#xD;
      learning outcomes of M-TEL with various modules of medical education. This is a randomized&#xD;
      controlled trial. We will recruit 60 UME students without previous training in ORL-HNS to&#xD;
      undergo the Group Embedded Figures Test to determine their cognitive styles such as field&#xD;
      dependence or field-independence. After blinded randomization, students are instructed on two&#xD;
      modules of emergent ORL-HNS disorders, using either a standard e-learning of text-figure&#xD;
      Power Point show or an interactive multimedia module. Subjects are evaluated on emergent&#xD;
      ORL-HNS disorders using text-based assessment and multimedia assessment take place prior to&#xD;
      and following instruction. After 7 days later, they will be assessed using global&#xD;
      satisfaction score and AttrakDiff2 questionnaire. We anticipate that this study can confirm&#xD;
      M-TEL can enhance the efficiency of the instruction of ORL-HNS and understand differences in&#xD;
      learning outcomes of M-TEL with various modules of medical education between field dependence&#xD;
      and filed independence using this platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      New designs of 6-year undergraduate medical education (UME) mainly include (1) integral&#xD;
      curricula of body organ system, (2) multiple methods of clinical teaching and assessment, and&#xD;
      (3) generalism in UME. UME is meant to enable graduates to become undifferentiated general&#xD;
      physicians. Accompany with decreasing educational hours in the classrooms and hospital,&#xD;
      essential but minor components of primary healthcare such as ophthalmology and&#xD;
      otolaryngology-head and neck surgery (ORL-HNS) is disproportionately under-represented in&#xD;
      UME. In Canada, substantial downstream effects on managing ORL-HNS problems have been noted&#xD;
      in family medicine residents. In order to improve learning insufficiency and enhance clinical&#xD;
      competency without increasing extra-hours in the classrooms and hospitals, novel medical&#xD;
      education stresses on enabling self-directory learning and increasing learning hours outside&#xD;
      the classrooms. Accordingly, we hypothesize that innovations in educational technology can&#xD;
      enhance the learning outcomes of ORL-HNS.&#xD;
&#xD;
      Purposes: This study is aimed to determine whether mobile technology in e-learning (M-TEL) is&#xD;
      an effective tool for the instruction of ORL-HNS and to compare effects of different&#xD;
      cognitive styles on learning outcomes of M-TEL with various modules of medical education.&#xD;
&#xD;
      Material and Methods:&#xD;
&#xD;
      This is a randomized controlled trial. Firstly, we have been setup a e-learning platform of&#xD;
      the Top 10 emergent ORL-HNS disorders with translating into an application (APP) function&#xD;
      that can execute in mobile devices. Secondly, we will recruit 60 UME students without&#xD;
      previous training in ORL-HNS to undergo the Group Embedded Figures Test to determine their&#xD;
      cognitive styles such as field dependence or field-independence. After blinded randomization,&#xD;
      students are instructed on two modules of emergent ORL-HNS disorders, using either a standard&#xD;
      e-learning of text-figure Power Point show or an interactive multimedia module. Subjects are&#xD;
      evaluated on emergent ORL-HNS disorders using a text-based assessment and a multimedia&#xD;
      assessment take place prior to and following instruction.&#xD;
&#xD;
      Anticipating Outcome:&#xD;
&#xD;
      This study can (1) establish a M-TEL of ORL-HNS that can deliver an innovatively mobile&#xD;
      e-learning to supplement the deficiency of the classroom hours, (2) confirm M-TEL can enhance&#xD;
      the efficiency of the instruction of ORL-HNS, and (3) understand differences in learning&#xD;
      outcomes of M-TEL with various modules of medical education between field dependence and&#xD;
      filed independence using this platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 23, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 5, 2017</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>This study was a prospective randomized controlled trial.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change in Multiple-choice Question (MCQ) Scores</measure>
    <time_frame>before and immediately after the M-TEL intervention</time_frame>
    <description>Subjects will undergo the duplicated 15-minute MCQ tests before after the M-TEL Subjects will undergo the duplicated 15-minute MCQ tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in Multimedia Situation Test (MST) Scores</measure>
    <time_frame>before and immediately after the M-TEL intervention</time_frame>
    <description>Subjects will undergo the duplicated 15-minute MST tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Satisfaction Score</measure>
    <time_frame>7 days after the M-TEL intervention</time_frame>
    <description>Global satisfaction score is measured using a visual analogue scale from 0 (very dissatisfied) to 10 (very satisfied) after 7 days post M-TEL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AttrakDiff2 Questionnaire: Pragmatic Quality Score</measure>
    <time_frame>7 days after the M-TEL intervention</time_frame>
    <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AttrakDiff2 Questionnaire: Hedonic Stimulation</measure>
    <time_frame>7 days after the M-TEL intervention</time_frame>
    <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AttrakDiff2 Questionnaire: Hedonic Identification</measure>
    <time_frame>7 days after the M-TEL intervention</time_frame>
    <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AttrakDiff2 Questionnaire: Attractiveness</measure>
    <time_frame>7 days after the M-TEL intervention</time_frame>
    <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Medical Education</condition>
  <arm_group>
    <arm_group_label>interactive multimedia module</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Power Point show module</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobile technology of e-learning (M-TEL)</intervention_name>
    <description>UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
    <arm_group_label>Power Point show module</arm_group_label>
    <arm_group_label>interactive multimedia module</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 20 years old;&#xD;
&#xD;
          2. UME students (defined as the three or four years of medical school training).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous ORL-HNS training;&#xD;
&#xD;
          2. Declining to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Ang Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Glicksman JT, Brandt MG, Parr J, Fung K. Needs assessment of undergraduate education in otolaryngology among family medicine residents. J Otolaryngol Head Neck Surg. 2008 Oct;37(5):668-75.</citation>
    <PMID>19128674</PMID>
  </reference>
  <reference>
    <citation>Wolff M, Wagner MJ, Poznanski S, Schiller J, Santen S. Not another boring lecture: engaging learners with active learning techniques. J Emerg Med. 2015 Jan;48(1):85-93. doi: 10.1016/j.jemermed.2014.09.010. Epub 2014 Oct 13.</citation>
    <PMID>25440868</PMID>
  </reference>
  <reference>
    <citation>Yavner SD, Pusic MV, Kalet AL, Song HS, Hopkins MA, Nick MW, Ellaway RH. Twelve tips for improving the effectiveness of web-based multimedia instruction for clinical learners. Med Teach. 2015 Mar;37(3):239-44. doi: 10.3109/0142159X.2014.933202. Epub 2014 Aug 11.</citation>
    <PMID>25109353</PMID>
  </reference>
  <reference>
    <citation>Alegria DA, Boscardin C, Poncelet A, Mayfield C, Wamsley M. Using tablets to support self-regulated learning in a longitudinal integrated clerkship. Med Educ Online. 2014 Mar 12;19:23638. doi: 10.3402/meo.v19.23638. eCollection 2014.</citation>
    <PMID>24646438</PMID>
  </reference>
  <reference>
    <citation>Chapman DM, Calhoun JG. Validation of learning style measures: implications for medical education practice. Med Educ. 2006 Jun;40(6):576-83. doi: 10.1111/j.1365-2929.2006.02476.x.</citation>
    <PMID>16700774</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>January 29, 2018</results_first_submitted>
  <results_first_submitted_qc>January 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2021</results_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive style</keyword>
  <keyword>e-learning</keyword>
  <keyword>mobile technology</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>otolaryngology-head and neck surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The individua participant data of UME students may be not suitable to be available to other researchers</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02971735/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 60 consecutive volunteers were recruited from a teaching clinic for the validation study from November 23, 2016 to July 5, 2017.</recruitment_details>
      <pre_assignment_details>All of the volunteers had at least a basic level of computer literacy, and they were shown the practical aspects of using tablets and applications. The inclusion criteria were as follows: 1) age &gt;20 years; and 2) undergraduate medical students (clerkship). The exclusion criteria were: 1) previous ORL-HNS training; and 2) declining to participate.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Interactive Multimedia Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
        <group group_id="P2">
          <title>Power Point Show Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Pretests including a 15-minute 10-question standard MCQ to evaluate the students' existing knowledge (range, 0-100) and a 15-minute 5-question MST to assess their existing competence (range, 0-100) with regards to &quot;emergent ORL-HNS disorders&quot; were given to the students.</population>
      <group_list>
        <group group_id="B1">
          <title>Interactive Multimedia Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
        <group group_id="B2">
          <title>Power Point Show Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" lower_limit="23" upper_limit="24"/>
                    <measurement group_id="B2" value="23" lower_limit="23" upper_limit="24"/>
                    <measurement group_id="B3" value="23" lower_limit="23" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>The cognitive style was assessed using the 25-item group embedded figures test after enrollment.</title>
          <description>The cognitive style of the participants was assessed using the 25-item GEFT after enrollment. On the basis of the number of correct answers given by the participants, the GEFT scores ranged from 0 (the most field-dependent [FD]) to 18 (the most field-independent [FI]). We stratified the students into two subgroups: &quot;classical FD&quot; (GEFT score ≤12) and &quot;classical FI&quot; (GEFT score &gt;12).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="15" upper_limit="18"/>
                    <measurement group_id="B2" value="17" lower_limit="16" upper_limit="18"/>
                    <measurement group_id="B3" value="17" lower_limit="15" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change in Multiple-choice Question (MCQ) Scores</title>
        <description>Subjects will undergo the duplicated 15-minute MCQ tests before after the M-TEL Subjects will undergo the duplicated 15-minute MCQ tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
        <time_frame>before and immediately after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Multiple-choice Question (MCQ) Scores</title>
          <description>Subjects will undergo the duplicated 15-minute MCQ tests before after the M-TEL Subjects will undergo the duplicated 15-minute MCQ tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
          <units>percentage of MCQ change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" lower_limit="13" upper_limit="76"/>
                    <measurement group_id="O2" value="45" lower_limit="30" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in Multimedia Situation Test (MST) Scores</title>
        <description>Subjects will undergo the duplicated 15-minute MST tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
        <time_frame>before and immediately after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Multimedia Situation Test (MST) Scores</title>
          <description>Subjects will undergo the duplicated 15-minute MST tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.</description>
          <units>percentage of MST change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-21" upper_limit="38"/>
                    <measurement group_id="O2" value="25" lower_limit="0" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Satisfaction Score</title>
        <description>Global satisfaction score is measured using a visual analogue scale from 0 (very dissatisfied) to 10 (very satisfied) after 7 days post M-TEL.</description>
        <time_frame>7 days after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Satisfaction Score</title>
          <description>Global satisfaction score is measured using a visual analogue scale from 0 (very dissatisfied) to 10 (very satisfied) after 7 days post M-TEL.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="6" upper_limit="9"/>
                    <measurement group_id="O2" value="6" lower_limit="4" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AttrakDiff2 Questionnaire: Pragmatic Quality Score</title>
        <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
        <time_frame>7 days after the M-TEL intervention</time_frame>
        <population>Pragmatic quality</population>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>AttrakDiff2 Questionnaire: Pragmatic Quality Score</title>
          <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
          <population>Pragmatic quality</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.7" upper_limit="2.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-0.6" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AttrakDiff2 Questionnaire: Hedonic Stimulation</title>
        <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
        <time_frame>7 days after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>AttrakDiff2 Questionnaire: Hedonic Stimulation</title>
          <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.6" upper_limit="2.0"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-1.0" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AttrakDiff2 Questionnaire: Hedonic Identification</title>
        <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
        <time_frame>7 days after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>AttrakDiff2 Questionnaire: Hedonic Identification</title>
          <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.7" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-0.2" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AttrakDiff2 Questionnaire: Attractiveness</title>
        <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
        <time_frame>7 days after the M-TEL intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interactive Multimedia Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
          <group group_id="O2">
            <title>Power Point Show Module</title>
            <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
          </group>
        </group_list>
        <measure>
          <title>AttrakDiff2 Questionnaire: Attractiveness</title>
          <description>For more delicately evaluate the acceptance of technical innovations, we will assess &quot;user experience&quot; using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. &quot;confusing - clear&quot;, &quot;unusual - ordinary&quot;, &quot;good - bad&quot;). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.4" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We collected adverse event data 7 days after intervention.</time_frame>
      <desc>Because no previous adverse event of e-learning had been reported, we collected possible adverse event data using an anonymous qualitative feedback questionnaire.</desc>
      <group_list>
        <group group_id="E1">
          <title>Interactive Multimedia Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
        <group group_id="E2">
          <title>Power Point Show Module</title>
          <description>Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.&#xD;
mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Li-Ang Lee</name_or_title>
      <organization>Linkou Chang Gung Memorial Hospital</organization>
      <phone>886 33281200 ext 3972</phone>
      <email>5738@cgmh.org.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02971735
org study id: 105-5290C
nct id: NCT02971735
lead sponsor: 
collaborator: 
has dmc: Yes
New designs of 6-year undergraduate medical education (UME) in Taiwan mainly include (1)
      integral curricula of body organ system, (2) multiple methods of clinical teaching and
      assessment, and (3) generalism in UME. Accompany with decreasing educational hours in the
      classrooms and hospital, essential but minor components of primary healthcare such as
      ophthalmology and otolaryngology-head and neck surgery (ORL-HNS) is disproportionately
      under-represented in UME. Novel medical education stresses on enabling self-directory
      learning and increasing learning hours outside the classrooms. Accordingly, we hypothesize
      that innovations in educational technology can enhance the learning outcomes of ORL-HNS. This
      study is aimed to determine whether mobile technology in e-learning (M-TEL) is an effective
      tool for the instruction of ORL-HNS and to compare effects of different cognitive styles on
      learning outcomes of M-TEL with various modules of medical education. This is a randomized
      controlled trial. We will recruit 60 UME students without previous training in ORL-HNS to
      undergo the Group Embedded Figures Test to determine their cognitive styles such as field
      dependence or field-independence. After blinded randomization, students are instructed on two
      modules of emergent ORL-HNS disorders, using either a standard e-learning of text-figure
      Power Point show or an interactive multimedia module. Subjects are evaluated on emergent
      ORL-HNS disorders using text-based assessment and multimedia assessment take place prior to
      and following instruction. After 7 days later, they will be assessed using global
      satisfaction score and AttrakDiff2 questionnaire. We anticipate that this study can confirm
      M-TEL can enhance the efficiency of the instruction of ORL-HNS and understand differences in
      learning outcomes of M-TEL with various modules of medical education between field dependence
      and filed independence using this platform.
Background:

      New designs of 6-year undergraduate medical education (UME) mainly include (1) integral
      curricula of body organ system, (2) multiple methods of clinical teaching and assessment, and
      (3) generalism in UME. UME is meant to enable graduates to become undifferentiated general
      physicians. Accompany with decreasing educational hours in the classrooms and hospital,
      essential but minor components of primary healthcare such as ophthalmology and
      otolaryngology-head and neck surgery (ORL-HNS) is disproportionately under-represented in
      UME. In Canada, substantial downstream effects on managing ORL-HNS problems have been noted
      in family medicine residents. In order to improve learning insufficiency and enhance clinical
      competency without increasing extra-hours in the classrooms and hospitals, novel medical
      education stresses on enabling self-directory learning and increasing learning hours outside
      the classrooms. Accordingly, we hypothesize that innovations in educational technology can
      enhance the learning outcomes of ORL-HNS.

      Purposes: This study is aimed to determine whether mobile technology in e-learning (M-TEL) is
      an effective tool for the instruction of ORL-HNS and to compare effects of different
      cognitive styles on learning outcomes of M-TEL with various modules of medical education.

      Material and Methods:

      This is a randomized controlled trial. Firstly, we have been setup a e-learning platform of
      the Top 10 emergent ORL-HNS disorders with translating into an application (APP) function
      that can execute in mobile devices. Secondly, we will recruit 60 UME students without
      previous training in ORL-HNS to undergo the Group Embedded Figures Test to determine their
      cognitive styles such as field dependence or field-independence. After blinded randomization,
      students are instructed on two modules of emergent ORL-HNS disorders, using either a standard
      e-learning of text-figure Power Point show or an interactive multimedia module. Subjects are
      evaluated on emergent ORL-HNS disorders using a text-based assessment and a multimedia
      assessment take place prior to and following instruction.

      Anticipating Outcome:

      This study can (1) establish a M-TEL of ORL-HNS that can deliver an innovatively mobile
      e-learning to supplement the deficiency of the classroom hours, (2) confirm M-TEL can enhance
      the efficiency of the instruction of ORL-HNS, and (3) understand differences in learning
      outcomes of M-TEL with various modules of medical education between field dependence and
      filed independence using this platform.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was a prospective randomized controlled trial.
primary purpose: Other
masking: None (Open Label)
measure: Percentage Change in Multiple-choice Question (MCQ) Scores
time frame: before and immediately after the M-TEL intervention
description: Subjects will undergo the duplicated 15-minute MCQ tests before after the M-TEL Subjects will undergo the duplicated 15-minute MCQ tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.
measure: Percentage Change in Multimedia Situation Test (MST) Scores
time frame: before and immediately after the M-TEL intervention
description: Subjects will undergo the duplicated 15-minute MST tests 15 minutes before the M-TEL intervention with either the IM module or the PPS module and immediately after the M-TEL intervention.
measure: Global Satisfaction Score
time frame: 7 days after the M-TEL intervention
description: Global satisfaction score is measured using a visual analogue scale from 0 (very dissatisfied) to 10 (very satisfied) after 7 days post M-TEL.
measure: AttrakDiff2 Questionnaire: Pragmatic Quality Score
time frame: 7 days after the M-TEL intervention
description: For more delicately evaluate the acceptance of technical innovations, we will assess "user experience" using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).
measure: AttrakDiff2 Questionnaire: Hedonic Stimulation
time frame: 7 days after the M-TEL intervention
description: For more delicately evaluate the acceptance of technical innovations, we will assess "user experience" using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).
measure: AttrakDiff2 Questionnaire: Hedonic Identification
time frame: 7 days after the M-TEL intervention
description: For more delicately evaluate the acceptance of technical innovations, we will assess "user experience" using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).
measure: AttrakDiff2 Questionnaire: Attractiveness
time frame: 7 days after the M-TEL intervention
description: For more delicately evaluate the acceptance of technical innovations, we will assess "user experience" using the AttrakDiff2. AttrakDiff2 is developed as a tool by Hassenzahl's research group to be able to quantify attractive, identifiable, stimulating, and pragmatic qualities. The tool consists of 28 seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Each of the mean values of an item group creates a scale value for pragmatic quality (PQ), hedonic stimulation (HQ-S), hedonic identification (HQ-I), and attractiveness (ATT) (range: -3-3).
arm group label: interactive multimedia module
arm group type: Experimental
description: Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module.
arm group label: Power Point show module
arm group type: Active Comparator
description: Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module.
intervention type: Other
intervention name: mobile technology of e-learning (M-TEL)
description: UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.
arm group label: Power Point show module
arm group label: interactive multimedia module
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Li-Ang Lee, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
citation: Glicksman JT, Brandt MG, Parr J, Fung K. Needs assessment of undergraduate education in otolaryngology among family medicine residents. J Otolaryngol Head Neck Surg. 2008 Oct;37(5):668-75.
PMID: 19128674
citation: Wolff M, Wagner MJ, Poznanski S, Schiller J, Santen S. Not another boring lecture: engaging learners with active learning techniques. J Emerg Med. 2015 Jan;48(1):85-93. doi: 10.1016/j.jemermed.2014.09.010. Epub 2014 Oct 13.
PMID: 25440868
citation: Yavner SD, Pusic MV, Kalet AL, Song HS, Hopkins MA, Nick MW, Ellaway RH. Twelve tips for improving the effectiveness of web-based multimedia instruction for clinical learners. Med Teach. 2015 Mar;37(3):239-44. doi: 10.3109/0142159X.2014.933202. Epub 2014 Aug 11.
PMID: 25109353
citation: Alegria DA, Boscardin C, Poncelet A, Mayfield C, Wamsley M. Using tablets to support self-regulated learning in a longitudinal integrated clerkship. Med Educ Online. 2014 Mar 12;19:23638. doi: 10.3402/meo.v19.23638. eCollection 2014.
PMID: 24646438
citation: Chapman DM, Calhoun JG. Validation of learning style measures: implications for medical education practice. Med Educ. 2006 Jun;40(6):576-83. doi: 10.1111/j.1365-2929.2006.02476.x.
PMID: 16700774
responsible party type: Sponsor
sharing ipd: No
ipd description: The individua participant data of UME students may be not suitable to be available to other researchers
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 