<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/NCT02997085</url>
  </required_header>
  <id_info>
    <org_study_id>2016-09-0140</org_study_id>
    <nct_id>NCT02997085</nct_id>
  </id_info>
  <brief_title>Virtual Reality for Pain Management Study</brief_title>
  <official_title>Virtual Reality for Pain Management Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seton Healthcare Family</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective&#xD;
      means of decreasing pain levels following treatment, and for significant periods of time.&#xD;
      Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity&#xD;
      associated with pain. While VR is clearly a promising, drug-free option for pain treatment,&#xD;
      existing VR systems are expensive and use unconvincing graphics. Recent advances in VR&#xD;
      technology (i.e., improved realism and immersion using 360-degree 3D technology and more&#xD;
      affordable delivery systems) allow the development of more realistic and more cost-effective&#xD;
      applications. Capitalizing on these advances and the investigators' experiences with VR&#xD;
      intervention development and evaluation, the current study will test a state-of-the-art VR&#xD;
      experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and&#xD;
      compare it to established standard computer generated imagery (CGI) 360° VVR content for pain&#xD;
      management intervention in a medical setting. The participant's participation will help the&#xD;
      investigators determine which VR intervention is most effective in reducing acute pain in&#xD;
      hospital patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Treatment Pain Questionnaire</measure>
    <time_frame>Immediately following intervention</time_frame>
    <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-Up Pain Questionnaire</measure>
    <time_frame>Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.</time_frame>
    <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence Inventory</measure>
    <time_frame>Immediately following intervention</time_frame>
    <description>Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absorption Survey</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Present Mood Questionnaire</measure>
    <time_frame>Every 10 minutes for 40 minutes following intervention</time_frame>
    <description>The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes Toward the Experience Survey</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Live-Action 360° Video Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CGI 360° Video Virtual Reality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Live-Action 360° Video Virtual Reality</intervention_name>
    <description>360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
    <arm_group_label>Live-Action 360° Video Virtual Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGI 360° Video Virtual Reality</intervention_name>
    <description>Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
    <arm_group_label>CGI 360° Video Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 65&#xD;
&#xD;
          -  Reports experiencing current pain not typical of day-to-day experience during&#xD;
             Pre-Treatment Pain Questionnaire at the onset of study visit by answering &quot;Yes&quot; to the&#xD;
             first question of the questionnaire. There is no specific threshold of how much pain&#xD;
             the participant must be in to be eligible for this study. The participant must be&#xD;
             experiencing current pain that is not related to day-to-day, normal experiences (such&#xD;
             as minor headaches, sprains, and toothaches).&#xD;
&#xD;
          -  Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental&#xD;
             Status Exam.&#xD;
&#xD;
          -  Patient in the acute and critical palliative care units, post surgical units, or acute&#xD;
             care orthopedic units at University Medical Center Brackenridge in Austin, TX.&#xD;
&#xD;
          -  Willing and able to provide informed consent and participate in the study visit and&#xD;
             study follow-up questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing or visually impaired where participant cannot use the Samsung Gear VR.&#xD;
&#xD;
          -  Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at&#xD;
             the onset of study visit.&#xD;
&#xD;
          -  Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini&#xD;
             Mental Status Exam&#xD;
&#xD;
          -  Limited mental competency and the inability to give informed, voluntary, written&#xD;
             consent to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Powers, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>February 11, 2021</results_first_submitted>
  <results_first_submitted_qc>June 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2021</results_first_posted>
  <last_update_submitted>June 1, 2021</last_update_submitted>
  <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Mark B. Powers</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Opioid</keyword>
  <keyword>Prescription pain reliever</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>October 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT02997085/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Live-Action 360° Video Virtual Reality</title>
          <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
        </group>
        <group group_id="P2">
          <title>CGI 360° Video Virtual Reality</title>
          <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
        </group>
        <group group_id="P3">
          <title>Waitlist</title>
          <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Live-Action 360° Video Virtual Reality</title>
          <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
        </group>
        <group group_id="B2">
          <title>CGI 360° Video Virtual Reality</title>
          <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
        </group>
        <group group_id="B3">
          <title>Waitlist</title>
          <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
        </group>
        <group group_id="B4">
          <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="34"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="103"/>
          </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </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="41.03" spread="14.14"/>
                    <measurement group_id="B2" value="43.83" spread="13.51"/>
                    <measurement group_id="B3" value="44.62" spread="16.17"/>
                    <measurement group_id="B4" value="43.17" spread="14.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Not to Report</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </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="34"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Questionnaire</title>
          <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.97" spread="1.88"/>
                    <measurement group_id="B2" value="5.22" spread="2.02"/>
                    <measurement group_id="B3" value="6.29" spread="2.37"/>
                    <measurement group_id="B4" value="5.83" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Present Mood Questionnaire</title>
          <description>The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.62" spread="3"/>
                    <measurement group_id="B2" value="2.17" spread="2.71"/>
                    <measurement group_id="B3" value="2.15" spread="2.35"/>
                    <measurement group_id="B4" value="2.33" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" spread="3.47"/>
                    <measurement group_id="B2" value="2.86" spread="3.05"/>
                    <measurement group_id="B3" value="3.18" spread="3.33"/>
                    <measurement group_id="B4" value="3.37" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.12" spread="3.22"/>
                    <measurement group_id="B2" value="4.71" spread="3.27"/>
                    <measurement group_id="B3" value="5.62" spread="3.58"/>
                    <measurement group_id="B4" value="4.80" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tranquil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.44" spread="3.25"/>
                    <measurement group_id="B2" value="6.06" spread="2.78"/>
                    <measurement group_id="B3" value="6.21" spread="2.71"/>
                    <measurement group_id="B4" value="5.86" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-Treatment Pain Questionnaire</title>
        <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
        <time_frame>Immediately following intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
          <group group_id="O3">
            <title>Waitlist</title>
            <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Treatment Pain Questionnaire</title>
          <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</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="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="2.3"/>
                    <measurement group_id="O2" value="2.77" spread="2.13"/>
                    <measurement group_id="O3" value="6.37" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Follow-Up Pain Questionnaire</title>
        <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
        <time_frame>Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
          <group group_id="O3">
            <title>Waitlist</title>
            <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
          </group>
        </group_list>
        <measure>
          <title>Follow-Up Pain Questionnaire</title>
          <description>The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current</description>
          <units>units 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="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.32"/>
                    <measurement group_id="O2" value="4.14" spread="2.72"/>
                    <measurement group_id="O3" value="3.7" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence Inventory</title>
        <description>Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.</description>
        <time_frame>Immediately following intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence Inventory</title>
          <description>Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.</description>
          <units>units 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="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ecological Validity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.06" spread="7.69"/>
                    <measurement group_id="O2" value="25.62" spread="12.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spatial Presence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.79" spread="6.99"/>
                    <measurement group_id="O2" value="22.18" spread="8.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="2.23"/>
                    <measurement group_id="O2" value="2" spread="5.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absorption Survey</title>
        <description>Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.</description>
        <time_frame>Immediately after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
        </group_list>
        <measure>
          <title>Absorption Survey</title>
          <description>Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.</description>
          <units>units 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="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.32" spread="16.52"/>
                    <measurement group_id="O2" value="96.2" spread="18.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Present Mood Questionnaire</title>
        <description>The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.</description>
        <time_frame>Every 10 minutes for 40 minutes following intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
          <group group_id="O3">
            <title>Waitlist</title>
            <description>Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.</description>
          </group>
        </group_list>
        <measure>
          <title>Present Mood Questionnaire</title>
          <description>The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.</description>
          <units>units 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="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".7" spread="1.45"/>
                    <measurement group_id="O2" value=".85" spread="1.88"/>
                    <measurement group_id="O3" value="2.25" spread="3.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="3.18"/>
                    <measurement group_id="O2" value="1.21" spread="2.27"/>
                    <measurement group_id="O3" value="2.25" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.52" spread="2.54"/>
                    <measurement group_id="O2" value="6.24" spread="3.38"/>
                    <measurement group_id="O3" value="5.34" spread="3.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tranquil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="2.3"/>
                    <measurement group_id="O2" value="7.62" spread="2.71"/>
                    <measurement group_id="O3" value="6.56" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Attitudes Toward the Experience Survey</title>
        <description>Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.</description>
        <time_frame>Immediately after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Live-Action 360° Video Virtual Reality</title>
            <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
          </group>
          <group group_id="O2">
            <title>CGI 360° Video Virtual Reality</title>
            <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</description>
          </group>
        </group_list>
        <measure>
          <title>Attitudes Toward the Experience Survey</title>
          <description>Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.</description>
          <units>units 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="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.35" spread="10.93"/>
                    <measurement group_id="O2" value="67.51" spread="16.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One year</time_frame>
      <desc>Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.</desc>
      <group_list>
        <group group_id="E1">
          <title>Live-Action 360° Video Virtual Reality</title>
          <description>Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.</description>
        </group>
        <group group_id="E2">
          <title>CGI 360° Video Virtual Reality</title>
          <description>CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.</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="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyestrain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Nausea from device usage.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizzy</sub_title>
                <description>Just dizzy from device.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Headache from device usage</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </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. Mark Powers</name_or_title>
      <organization>Baylor Scott &amp; White Research Institute</organization>
      <phone>2148652409</phone>
      <email>Mark.Powers1@bswhealth.org</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/NCT02997085
org study id: 2016-09-0140
nct id: NCT02997085
lead sponsor: 
collaborator: 
has dmc: No
Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective
      means of decreasing pain levels following treatment, and for significant periods of time.
      Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity
      associated with pain. While VR is clearly a promising, drug-free option for pain treatment,
      existing VR systems are expensive and use unconvincing graphics. Recent advances in VR
      technology (i.e., improved realism and immersion using 360-degree 3D technology and more
      affordable delivery systems) allow the development of more realistic and more cost-effective
      applications. Capitalizing on these advances and the investigators' experiences with VR
      intervention development and evaluation, the current study will test a state-of-the-art VR
      experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and
      compare it to established standard computer generated imagery (CGI) 360° VVR content for pain
      management intervention in a medical setting. The participant's participation will help the
      investigators determine which VR intervention is most effective in reducing acute pain in
      hospital patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Post-Treatment Pain Questionnaire
time frame: Immediately following intervention
description: The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current
measure: Follow-Up Pain Questionnaire
time frame: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
description: The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current
measure: Presence Inventory
time frame: Immediately following intervention
description: Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.
measure: Absorption Survey
time frame: Immediately after intervention
description: Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.
measure: Present Mood Questionnaire
time frame: Every 10 minutes for 40 minutes following intervention
description: The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
measure: Attitudes Toward the Experience Survey
time frame: Immediately after intervention
description: Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.
arm group label: Live-Action 360° Video Virtual Reality
arm group type: Experimental
arm group label: CGI 360° Video Virtual Reality
arm group type: Active Comparator
arm group label: Waitlist
arm group type: No Intervention
description: Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
intervention type: Device
intervention name: Live-Action 360° Video Virtual Reality
description: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
arm group label: Live-Action 360° Video Virtual Reality
intervention type: Device
intervention name: CGI 360° Video Virtual Reality
description: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
arm group label: CGI 360° Video Virtual Reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mark Powers, Ph.D.
role: Principal Investigator
affiliation: University of Texas at Austin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Mark B. Powers
investigator title: Research Associate Professor
mesh term: Acute Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 