<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/NCT04470375</url>
  </required_header>
  <id_info>
    <org_study_id>USD-IRB-20-129</org_study_id>
    <nct_id>NCT04470375</nct_id>
  </id_info>
  <brief_title>Virtual Reality Pain Neuroscience Education for Middle School Students</brief_title>
  <official_title>Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Dakota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Dakota</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>
      Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform&#xD;
      with middle school students. The investigators have previously studied the use of PNE with in&#xD;
      person educational sessions with middle school kids and video recorded sessions. This study&#xD;
      will be looking into utilizing the VR platform for delivery of the educational information.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential middle school students will be contacted through fliers to local parents in the&#xD;
      Louisville, KY area via various sports team events. The investigators have secured a meeting&#xD;
      room space at a large reception room at Lake Forest Country Club (Louisville, KY) on August&#xD;
      4, 2020. Potential participants will call to schedule time for participation to allow for&#xD;
      proper staggering of participants arriving on the day of data collection.&#xD;
&#xD;
      Research team will set up informed consent space at the entrance to the reception room and&#xD;
      stagger participant arrival time to reduce contact with other participants. This space will&#xD;
      be cleaned and disinfected regularly during the consenting process as new participants&#xD;
      arrive. Once student and parent arrives they will complete informed consent and COVID-19&#xD;
      screening form before being allowed into research space (reception room). Each participant&#xD;
      will be given a pen to keep during the research study and go home with also provided with&#xD;
      hand sanitizer to use before and after. No pens will be reused with other participants. Masks&#xD;
      will be made available for anyone that requests one, but they will not be required while at&#xD;
      the testing location. Parents of child will be allowed to sit in waiting chair keeping 6 feet&#xD;
      of distance from anyone else. The child research participant will be lead to a chair in the&#xD;
      room and complete pre-test questionnaire and then they will be set-up with a Virtual Reality&#xD;
      (VR) device (cleaned and disinfected between each use) and go through a VR educational&#xD;
      experience (~30 minutes) on Pain Neuroscience Education (PNE). Upon completion of the VR&#xD;
      educational session they will complete post-test questionnaire and then be able to leave.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">August 5, 2020</completion_date>
  <primary_completion_date type="Actual">August 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single group of students receiving Virtual Reality education</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later</measure>
    <time_frame>Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR</time_frame>
    <description>Pain beliefs questionnaire: 11 point Likert scale (0= strongly disagree, 10= strongly agree) on 5 pain beliefs questions. Some questions are positively worded so higher scores = more positive beliefs (#1, 4, 5). Some are negatively worded so higher scores = worse beliefs (#2, 3) question 1 - Pain is normal; without being able to feel pain you will not survive question 2 - Pain means something is wrong with your tissues question 3 - Pain always means you have to stop what you are doing question 4 - You can control how much pain you feel question 5 - Your brain decides if you feel pain, not your tissues</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later</measure>
    <time_frame>Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention</time_frame>
    <description>12 true false questions, higher scores of correct answers demonstrate higher pain knowledge. 12 points is highest score, 0 points is lowest score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later</measure>
    <time_frame>Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes</time_frame>
    <description>7 point Likert scale (0= completely disagree, 6=completely agree), 5 questions (question 1-Physical activity may cause pain, question 2-Physical activity makes pain worse, question 3-Physical activity might harm my tissues if I am hurting, question 4-Physical activity should not be done if it increases pain, question 5-Physical activities cannot be done if it makes pain worse). The higher the score the higher the fear avoidance beliefs. Lowest score 0, highest score 30.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pain</condition>
  <condition>Education</condition>
  <condition>Virtual Reality</condition>
  <arm_group>
    <arm_group_label>VR pain education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students receiving the 45 minute pain education through Virtual Reality</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality Pain Neuroscience Education</intervention_name>
    <description>Use of virtual reality media to provide pain neuroscience education</description>
    <arm_group_label>VR pain education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing to view VR educational session&#xD;
&#xD;
          -  in grades 5, 6, 7, or 8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has been through PNE educational program previously&#xD;
&#xD;
          -  aversion to VR or problems with viewing VR in the past&#xD;
&#xD;
          -  history of epilepsy or seizures&#xD;
&#xD;
          -  eye surgery or injury within the last 6 months&#xD;
&#xD;
          -  open sores or wounds around where VR googles are worn on face&#xD;
&#xD;
          -  anyone who has had a concussion that has not been cleared for full activity or&#xD;
             experiencing any post-concussion syndrome symptoms currently.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kory J Zimney, PT, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Dakota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evidence in Motion (Lake Forest Country Clug)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <results_first_submitted>September 18, 2020</results_first_submitted>
  <results_first_submitted_qc>November 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2020</results_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Dakota</investigator_affiliation>
    <investigator_full_name>Kory Zimney</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be stored for required 3 year period after study. No intent at this time to share data.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04470375/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04470375/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Middle school students (Grades 5-8), live in Louisville, KY area, no PNE training sessions in the past, no history of epilepsy or seizures or adverse events with viewing VR in the past.</recruitment_details>
      <pre_assignment_details>No exclusion prior to assignment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Middle School VR Students</title>
          <description>Middle school students viewing the VR on PNE</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Middle school students</population>
      <group_list>
        <group group_id="B1">
          <title>Middle School VR Students</title>
          <description>Middle school students viewing the VR on PNE</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.45" spread="1.2"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>current pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>history of any previous pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>one week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>more than 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain beliefs questionnaire</title>
          <description>Pain beliefs questions: answer on 11 point Likert Scale from strongly disagree=0 to strongly agree=10&#xD;
Pain is normal; without being able to feel pain you will not survive.&#xD;
Pain means something is wrong with your tissues&#xD;
Pain always means you have to stop what you are doing&#xD;
You can control how much pain you feel&#xD;
Your brain decides if you feel pain, not your tissues</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>pain beliefs question 1.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pain beliefs question 2.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain beliefs question 3.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.95" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pain beliefs question 4.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pain beliefs question 5.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.7" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>revised Neurophysiology of Pain Questionnaire</title>
          <description>12 true/false questions regarding the neurophysiology of pain. Answers of unsure are marked as incorrect answers as individuals are told not to guess at answer and only answer if they think they know the correct answer. Score is the number of correct answers provided.</description>
          <units>correct answers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical activity Fear Avoidance Beliefs Questionnaire</title>
          <description>Questionnaire on fear of physical activity. 7 point Likert scale from completely disagree=0, to completely agree=6&#xD;
Physical activity may cause pain&#xD;
Physical activity makes pain worse&#xD;
Physical activity might harm my tissues if I am hurting&#xD;
Physical activity should not be done if it increases pain&#xD;
Physical activities cannot be done if it makes pain worse</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>question 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.3" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later</title>
        <description>Pain beliefs questionnaire: 11 point Likert scale (0= strongly disagree, 10= strongly agree) on 5 pain beliefs questions. Some questions are positively worded so higher scores = more positive beliefs (#1, 4, 5). Some are negatively worded so higher scores = worse beliefs (#2, 3) question 1 - Pain is normal; without being able to feel pain you will not survive question 2 - Pain means something is wrong with your tissues question 3 - Pain always means you have to stop what you are doing question 4 - You can control how much pain you feel question 5 - Your brain decides if you feel pain, not your tissues</description>
        <time_frame>Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Middle School VR Students</title>
            <description>Middle school students viewing the VR on PNE</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later</title>
          <description>Pain beliefs questionnaire: 11 point Likert scale (0= strongly disagree, 10= strongly agree) on 5 pain beliefs questions. Some questions are positively worded so higher scores = more positive beliefs (#1, 4, 5). Some are negatively worded so higher scores = worse beliefs (#2, 3) question 1 - Pain is normal; without being able to feel pain you will not survive question 2 - Pain means something is wrong with your tissues question 3 - Pain always means you have to stop what you are doing question 4 - You can control how much pain you feel question 5 - Your brain decides if you feel pain, not your tissues</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>question 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".35" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".95" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".45" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".55" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Paired samples pre-post t-test</non_inferiority_desc>
            <p_value>.137</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later</title>
        <description>12 true false questions, higher scores of correct answers demonstrate higher pain knowledge. 12 points is highest score, 0 points is lowest score</description>
        <time_frame>Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Middle School VR Students</title>
            <description>Middle school students viewing the VR on PNE</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later</title>
          <description>12 true false questions, higher scores of correct answers demonstrate higher pain knowledge. 12 points is highest score, 0 points is lowest score</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Paired samples t-test (pre - post measure of group)</non_inferiority_desc>
            <p_value>.010</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later</title>
        <description>7 point Likert scale (0= completely disagree, 6=completely agree), 5 questions (question 1-Physical activity may cause pain, question 2-Physical activity makes pain worse, question 3-Physical activity might harm my tissues if I am hurting, question 4-Physical activity should not be done if it increases pain, question 5-Physical activities cannot be done if it makes pain worse). The higher the score the higher the fear avoidance beliefs. Lowest score 0, highest score 30.</description>
        <time_frame>Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Middle School VR Students</title>
            <description>Middle school students viewing the VR on PNE</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later</title>
          <description>7 point Likert scale (0= completely disagree, 6=completely agree), 5 questions (question 1-Physical activity may cause pain, question 2-Physical activity makes pain worse, question 3-Physical activity might harm my tissues if I am hurting, question 4-Physical activity should not be done if it increases pain, question 5-Physical activities cannot be done if it makes pain worse). The higher the score the higher the fear avoidance beliefs. Lowest score 0, highest score 30.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>question 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.05" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".55" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>question 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.35" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Paired samples t-test (pre post measure of group)</non_inferiority_desc>
            <p_value>.591</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were assessed for from the start of Virtual reality during the entire educational session (approximately 45 minutes) and then after completion of the VR educational experience for 15 minutes while the completed the ending data collection. 1 hour total time.</time_frame>
      <desc>any episode of ill feeling while performing the VR or immediately (15 minutes) after performing VR</desc>
      <group_list>
        <group group_id="E1">
          <title>Middle School VR Students</title>
          <description>Middle school students viewing the VR on PNE</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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
              </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. Kory Zimney</name_or_title>
      <organization>University of South Dakota</organization>
      <phone>16056586373</phone>
      <email>kory.zimney@usd.edu</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/NCT04470375
org study id: USD-IRB-20-129
nct id: NCT04470375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform
      with middle school students. The investigators have previously studied the use of PNE with in
      person educational sessions with middle school kids and video recorded sessions. This study
      will be looking into utilizing the VR platform for delivery of the educational information.
Potential middle school students will be contacted through fliers to local parents in the
      Louisville, KY area via various sports team events. The investigators have secured a meeting
      room space at a large reception room at Lake Forest Country Club (Louisville, KY) on August
      4, 2020. Potential participants will call to schedule time for participation to allow for
      proper staggering of participants arriving on the day of data collection.

      Research team will set up informed consent space at the entrance to the reception room and
      stagger participant arrival time to reduce contact with other participants. This space will
      be cleaned and disinfected regularly during the consenting process as new participants
      arrive. Once student and parent arrives they will complete informed consent and COVID-19
      screening form before being allowed into research space (reception room). Each participant
      will be given a pen to keep during the research study and go home with also provided with
      hand sanitizer to use before and after. No pens will be reused with other participants. Masks
      will be made available for anyone that requests one, but they will not be required while at
      the testing location. Parents of child will be allowed to sit in waiting chair keeping 6 feet
      of distance from anyone else. The child research participant will be lead to a chair in the
      room and complete pre-test questionnaire and then they will be set-up with a Virtual Reality
      (VR) device (cleaned and disinfected between each use) and go through a VR educational
      experience (~30 minutes) on Pain Neuroscience Education (PNE). Upon completion of the VR
      educational session they will complete post-test questionnaire and then be able to leave.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single group of students receiving Virtual Reality education
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later
time frame: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR
description: Pain beliefs questionnaire: 11 point Likert scale (0= strongly disagree, 10= strongly agree) on 5 pain beliefs questions. Some questions are positively worded so higher scores = more positive beliefs (#1, 4, 5). Some are negatively worded so higher scores = worse beliefs (#2, 3) question 1 - Pain is normal; without being able to feel pain you will not survive question 2 - Pain means something is wrong with your tissues question 3 - Pain always means you have to stop what you are doing question 4 - You can control how much pain you feel question 5 - Your brain decides if you feel pain, not your tissues
measure: Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later
time frame: Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention
description: 12 true false questions, higher scores of correct answers demonstrate higher pain knowledge. 12 points is highest score, 0 points is lowest score
measure: Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later
time frame: Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes
description: 7 point Likert scale (0= completely disagree, 6=completely agree), 5 questions (question 1-Physical activity may cause pain, question 2-Physical activity makes pain worse, question 3-Physical activity might harm my tissues if I am hurting, question 4-Physical activity should not be done if it increases pain, question 5-Physical activities cannot be done if it makes pain worse). The higher the score the higher the fear avoidance beliefs. Lowest score 0, highest score 30.
arm group label: VR pain education
arm group type: Experimental
description: Students receiving the 45 minute pain education through Virtual Reality
intervention type: Behavioral
intervention name: Virtual Reality Pain Neuroscience Education
description: Use of virtual reality media to provide pain neuroscience education
arm group label: VR pain education
criteria: 
gender: All
minimum age: 10 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kory J Zimney, PT, DPT
role: Principal Investigator
affiliation: University of South Dakota
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Dakota
investigator full name: Kory Zimney
investigator title: Associate Professor
sharing ipd: No
ipd description: Data will be stored for required 3 year period after study. No intent at this time to share data.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 