<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/NCT04449341</url>
  </required_header>
  <id_info>
    <org_study_id>921118</org_study_id>
    <nct_id>NCT04449341</nct_id>
  </id_info>
  <brief_title>Can Virtual Reality Reduce Pain and Anxiety During Blood Draw</brief_title>
  <official_title>Can Virtual Reality Reduce Patient's Pain, Improve Patient's Experience, and Reduce Procedure Related Anxiety With Venipuncture? A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C.R.Darnall Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C.R.Darnall Army Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult patients aged 18-50 undergoing blood draw for routine lab evaluation will be randomized&#xD;
      to a control group or experimental group to assess if the use of virtual reality reduces&#xD;
      procedural pain (primary outcome) and procedural anxiety (secondary outcome) during&#xD;
      venipuncture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled trial comparing standard practice for conducting&#xD;
      venipuncture to standard practice with the addition of Virtual Reality using the Oculus Go&#xD;
      Head Mounted Display (HMD). The study will be performed on volunteers who are reporting to&#xD;
      the phlebotomy lab to have venipuncture for blood draws that were previously ordered by their&#xD;
      health care providers. Participants who were not already scheduled to undergo routine&#xD;
      venipuncture will not be included.&#xD;
&#xD;
      When approaching the ticket stand to draw a waiting number for the lab, prospective&#xD;
      participants will be asked by an assistant investigator located near the kiosk if they are&#xD;
      interested in participating in the study. If the participants express interest, they will be&#xD;
      directed to the screening station. The screening station will be set up in a private room&#xD;
      near the lab waiting area, and participants will be screened for eligibility and educated on&#xD;
      the benefits and risks of the study. They will also provide informed consent if they decide&#xD;
      to participate.&#xD;
&#xD;
      All participants will be asked to fill out a self-reported data questionnaire in addition to&#xD;
      the informed consent document to assess for inclusion and exclusion criteria discussed later&#xD;
      in this protocol. This questionnaire will assess the participant's expected level of anxiety&#xD;
      prior to the procedure and expected level of pain associated with the procedure by utilizing&#xD;
      a visual analog scale (VAS). The VAS will be on a 100 millimeter line.&#xD;
&#xD;
      Once approved for participation in the study all participants will undergo a brief&#xD;
      instructional class on how to operate the HMD and will be allowed sufficient time to become&#xD;
      comfortable with its use. The investigators expect approximately 5-10 minutes to be required&#xD;
      for this portion of the study. Once familiar with the use of the virtual reality headset,&#xD;
      participants will be asked to randomly draw an envelope from a container. This envelope will&#xD;
      contain a block and sequence number. The block and sequence number will be the subject&#xD;
      identification and will correspond to a predetermined number set on a separate document that&#xD;
      will determine if the participant will use the HMD during venipuncture or not. The screener&#xD;
      will not have immediate access to the list showing which group the participant will be&#xD;
      assigned to. One member of the study team will be present in the lab room to ensure the&#xD;
      participant uses the virtual reality headset (or not) according to what is randomly drawn.&#xD;
      This member of the research team will have the list showing whether or not the participant is&#xD;
      assigned to the control arm or the experimental arm. The participants will then proceed to&#xD;
      the specimen room to undergo venipuncture.&#xD;
&#xD;
      Venipuncture for both groups will be occur in the non-dominant arm. The reasoning for this is&#xD;
      that the Oculus Go requires one free hand to use a controller. This will ensure that the&#xD;
      individuals participating are able to effectively use the device. Those unable to undergo&#xD;
      venipuncture in the nondominant arm will undergo venipuncture in the dominant arm instead and&#xD;
      will use the Oculus Go dominant arm will undergo venipuncture in the dominant arm instead and&#xD;
      will use the Oculus Go controller with their non-dominant hand.&#xD;
&#xD;
      Those utilizing the Oculus Go HMD will be interacting with the virtual reality game Ocean&#xD;
      Rift. They will utilize a single controller to explore an underwater safari park. Ocean Rift&#xD;
      has multiple environments to choose from, including coral reefs, ship wrecks, lagoons, the&#xD;
      arctic, and prehistoric seas. Participants may interact with and and learn about different&#xD;
      creatures to include dolphins, turtles, orcas, ray, whales, sea lions, manatees, and&#xD;
      dinosaurs. During the game users may travel where they please and interact with what they&#xD;
      choose. The virtual reality device is equipped with head-tracking software that allows the&#xD;
      user to choose direction by looking around. The entire interior and exterior of the headset&#xD;
      will be cleaned with alcohol-based wipes after each use. Alcohol will be used since it is&#xD;
      generally well-tolerated on human skin, and since it evaporates quickly. The headset will be&#xD;
      dried in the open air for a minimum of two minutes between each subject's use.&#xD;
&#xD;
      Those not using the virtual reality will still wear a headset that will simply be turned off.&#xD;
      This is to ensure that any significant change noted with the virtual reality is due to the&#xD;
      use of virtual reality itself, and not simply due to &quot;blindfolding&quot; the patient during the&#xD;
      procedure.&#xD;
&#xD;
      As some patients experiencing anxiety may be tempted to move during the procedure, lab&#xD;
      personnel will instruct participants to remain still during venipuncture. Participants will&#xD;
      be advised that they may take breaks as needed if anxiety becomes overwhelming.&#xD;
&#xD;
      After undergoing the procedure, each participant will be asked to fill out the postprocedure&#xD;
      questionnaire and return it to the study team member present in the lab room, who will clean&#xD;
      the headset as the participant completes the questionnaire. This questionnaire assesses the&#xD;
      patient's pain intensity and level of anxiety with the VAS similar to the VAS assessing pain,&#xD;
      as well as the patient's satisfaction with the visit which will be measured utilizing a&#xD;
      Likert scale for individual questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">July 9, 2020</completion_date>
  <primary_completion_date type="Actual">July 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural Pain</measure>
    <time_frame>2 months</time_frame>
    <description>Determine if use of Oculus Go headset reduces procedural pain perception utilizing the visual analog scale, which measures pain on a linear scale from 0 to 100 millimeters, with 0 being no pain and 100 being maximum pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Anxiety</measure>
    <time_frame>2 months</time_frame>
    <description>Determine if use of Oculus Go headset reduces procedural anxiety utilizing the visual analog scale, which measures anxiety on a linear scale from 0 to 100 millimeters, with 0 being no anxiety and 100 being maximum anxiety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Procedural Anxiety</condition>
  <condition>Procedural Pain</condition>
  <arm_group>
    <arm_group_label>Standard care venipuncture with additional of virtual reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care venipuncture without addition of virtual reality</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oculus Go headset with Ocean Rift application</intervention_name>
    <description>Information already included in arm description</description>
    <arm_group_label>Standard care venipuncture with additional of virtual reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-50&#xD;
&#xD;
          -  Currently scheduled to undergo venipuncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old or greater than 50 years old&#xD;
&#xD;
          -  History of motion sickness (nausea or vertigo)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Reported history of blood borne disease (no request will be made for which disease&#xD;
             participant has)&#xD;
&#xD;
          -  Use of pain medication(s) on day of study&#xD;
&#xD;
          -  Current use of medical devices, including hearing aids, pacemakers, implanted cardiac&#xD;
             defibrillators&#xD;
&#xD;
          -  Currently experiencing headache/migraine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew J Perdue, PA</last_name>
    <role>Principal Investigator</role>
    <affiliation>C.R.Darnall Army Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carl R Darnall Army Medical Center</name>
      <address>
        <city>Fort Hood</city>
        <state>Texas</state>
        <zip>76544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://download.militaryonesource.mil/12038/MOS/Reports/2018-demographics-report.pdf</url>
    <description>2018 Demographics Report: Profile of the Military Community</description>
  </link>
  <reference>
    <citation>Atzori B, Hoffman HG, Vagnoli L, Patterson DR, Alhalabi W, Messeri A, Lauro Grotto R. Virtual Reality Analgesia During Venipuncture in Pediatric Patients With Onco-Hematological Diseases. Front Psychol. 2018 Dec 20;9:2508. doi: 10.3389/fpsyg.2018.02508. eCollection 2018.</citation>
    <PMID>30618938</PMID>
  </reference>
  <reference>
    <citation>Cassidy KL, Reid GJ, McGrath PJ, Finley GA, Smith DJ, Morley C, Szudek EA, Morton B. Watch needle, watch TV: Audiovisual distraction in preschool immunization. Pain Med. 2002 Jun;3(2):108-18. doi: 10.1046/j.1526-4637.2002.02027.x.</citation>
    <PMID>15102157</PMID>
  </reference>
  <reference>
    <citation>Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x.</citation>
    <PMID>14525749</PMID>
  </reference>
  <reference>
    <citation>Dahlquist LM, Weiss KE, Law EF, Sil S, Herbert LJ, Horn SB, Wohlheiter K, Ackerman CS. Effects of videogame distraction and a virtual reality type head-mounted display helmet on cold pressor pain in young elementary school-aged children. J Pediatr Psychol. 2010 Jul;35(6):617-25. doi: 10.1093/jpepsy/jsp082. Epub 2009 Sep 28.</citation>
    <PMID>19786489</PMID>
  </reference>
  <reference>
    <citation>Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014 Dec;30(12):1089-98. doi: 10.1097/AJP.0000000000000064.</citation>
    <PMID>24535053</PMID>
  </reference>
  <reference>
    <citation>Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.</citation>
    <PMID>16640481</PMID>
  </reference>
  <reference>
    <citation>Gold JI, Belmont KA, Thomas DA. The neurobiology of virtual reality pain attenuation. Cyberpsychol Behav. 2007 Aug;10(4):536-44. doi: 10.1089/cpb.2007.9993.</citation>
    <PMID>17711362</PMID>
  </reference>
  <reference>
    <citation>Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.</citation>
    <PMID>11587113</PMID>
  </reference>
  <reference>
    <citation>Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.</citation>
    <PMID>15327820</PMID>
  </reference>
  <reference>
    <citation>Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.</citation>
    <PMID>21779307</PMID>
  </reference>
  <reference>
    <citation>Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.</citation>
    <PMID>20691523</PMID>
  </reference>
  <reference>
    <citation>Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.</citation>
    <PMID>11719741</PMID>
  </reference>
  <reference>
    <citation>Moore B, Stocks C, Owens P. Trends in Emergency Department Visits, 2006-2014. Healthcare Cost and Utilization Project (HCUP) Statistical Brief #227. 2017</citation>
  </reference>
  <reference>
    <citation>Wiederhold BK, Gao K, Kong L, Wiederhold MD. Mobile devices as adjunctive pain management tools. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):385-9. doi: 10.1089/cyber.2014.0202.</citation>
    <PMID>24892202</PMID>
  </reference>
  <reference>
    <citation>Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.</citation>
    <PMID>31889358</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <results_first_submitted>May 16, 2021</results_first_submitted>
  <results_first_submitted_qc>May 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2021</results_first_posted>
  <last_update_submitted>July 10, 2021</last_update_submitted>
  <last_update_submitted_qc>July 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>C.R.Darnall Army Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew J. Perdue, DSc, PA-C</investigator_full_name>
    <investigator_title>Fellow, US Army-Baylor DSc Emergency Medicine PA Studies, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>venipuncture</keyword>
  <keyword>blood draw</keyword>
  <keyword>Oculus Go</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04449341/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Virtual Reality</title>
          <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset&#xD;
Oculus Go headset with Ocean Rift application: Information already included in arm description</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Care Venipuncture With Additional of Virtual Reality</title>
          <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset&#xD;
Oculus Go headset with Ocean Rift application: Information already included in arm description</description>
        </group>
        <group group_id="B2">
          <title>Standard Care Venipuncture Without Addition of Virtual Reality</title>
          <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Procedural Pain</title>
        <description>Determine if use of Oculus Go headset reduces procedural pain perception utilizing the visual analog scale, which measures pain on a linear scale from 0 to 100 millimeters, with 0 being no pain and 100 being maximum pain</description>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care Venipuncture With Additional of Virtual Reality</title>
            <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset&#xD;
Oculus Go headset with Ocean Rift application: Information already included in arm description</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Venipuncture Without Addition of Virtual Reality</title>
            <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Pain</title>
          <description>Determine if use of Oculus Go headset reduces procedural pain perception utilizing the visual analog scale, which measures pain on a linear scale from 0 to 100 millimeters, with 0 being no pain and 100 being maximum pain</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" lower_limit="0.25" upper_limit="30.75"/>
                    <measurement group_id="O2" value="5.00" lower_limit="1.00" upper_limit="24.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedural Anxiety</title>
        <description>Determine if use of Oculus Go headset reduces procedural anxiety utilizing the visual analog scale, which measures anxiety on a linear scale from 0 to 100 millimeters, with 0 being no anxiety and 100 being maximum anxiety</description>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care Venipuncture With Additional of Virtual Reality</title>
            <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset&#xD;
Oculus Go headset with Ocean Rift application: Information already included in arm description</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Venipuncture Without Addition of Virtual Reality</title>
            <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Anxiety</title>
          <description>Determine if use of Oculus Go headset reduces procedural anxiety utilizing the visual analog scale, which measures anxiety on a linear scale from 0 to 100 millimeters, with 0 being no anxiety and 100 being maximum anxiety</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1.00" upper_limit="24.25"/>
                    <measurement group_id="O2" value="6.5" lower_limit=".25" upper_limit="30.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard Care Venipuncture With Additional of Virtual Reality</title>
          <description>Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset&#xD;
Oculus Go headset with Ocean Rift application: Information already included in arm description</description>
        </group>
        <group group_id="E2">
          <title>Standard Care Venipuncture Without Addition of Virtual Reality</title>
          <description>Patients undergoing blood draw while wearing Oculus Go headset that is turned off</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Matthew Perdue</name_or_title>
      <organization>Carl R Darnall Army Medical Center</organization>
      <phone>(254) 553-4653</phone>
      <email>matthewperdue94@gmail.com</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/NCT04449341
org study id: 921118
nct id: NCT04449341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Adult patients aged 18-50 undergoing blood draw for routine lab evaluation will be randomized
      to a control group or experimental group to assess if the use of virtual reality reduces
      procedural pain (primary outcome) and procedural anxiety (secondary outcome) during
      venipuncture.
A prospective randomized controlled trial comparing standard practice for conducting
      venipuncture to standard practice with the addition of Virtual Reality using the Oculus Go
      Head Mounted Display (HMD). The study will be performed on volunteers who are reporting to
      the phlebotomy lab to have venipuncture for blood draws that were previously ordered by their
      health care providers. Participants who were not already scheduled to undergo routine
      venipuncture will not be included.

      When approaching the ticket stand to draw a waiting number for the lab, prospective
      participants will be asked by an assistant investigator located near the kiosk if they are
      interested in participating in the study. If the participants express interest, they will be
      directed to the screening station. The screening station will be set up in a private room
      near the lab waiting area, and participants will be screened for eligibility and educated on
      the benefits and risks of the study. They will also provide informed consent if they decide
      to participate.

      All participants will be asked to fill out a self-reported data questionnaire in addition to
      the informed consent document to assess for inclusion and exclusion criteria discussed later
      in this protocol. This questionnaire will assess the participant's expected level of anxiety
      prior to the procedure and expected level of pain associated with the procedure by utilizing
      a visual analog scale (VAS). The VAS will be on a 100 millimeter line.

      Once approved for participation in the study all participants will undergo a brief
      instructional class on how to operate the HMD and will be allowed sufficient time to become
      comfortable with its use. The investigators expect approximately 5-10 minutes to be required
      for this portion of the study. Once familiar with the use of the virtual reality headset,
      participants will be asked to randomly draw an envelope from a container. This envelope will
      contain a block and sequence number. The block and sequence number will be the subject
      identification and will correspond to a predetermined number set on a separate document that
      will determine if the participant will use the HMD during venipuncture or not. The screener
      will not have immediate access to the list showing which group the participant will be
      assigned to. One member of the study team will be present in the lab room to ensure the
      participant uses the virtual reality headset (or not) according to what is randomly drawn.
      This member of the research team will have the list showing whether or not the participant is
      assigned to the control arm or the experimental arm. The participants will then proceed to
      the specimen room to undergo venipuncture.

      Venipuncture for both groups will be occur in the non-dominant arm. The reasoning for this is
      that the Oculus Go requires one free hand to use a controller. This will ensure that the
      individuals participating are able to effectively use the device. Those unable to undergo
      venipuncture in the nondominant arm will undergo venipuncture in the dominant arm instead and
      will use the Oculus Go dominant arm will undergo venipuncture in the dominant arm instead and
      will use the Oculus Go controller with their non-dominant hand.

      Those utilizing the Oculus Go HMD will be interacting with the virtual reality game Ocean
      Rift. They will utilize a single controller to explore an underwater safari park. Ocean Rift
      has multiple environments to choose from, including coral reefs, ship wrecks, lagoons, the
      arctic, and prehistoric seas. Participants may interact with and and learn about different
      creatures to include dolphins, turtles, orcas, ray, whales, sea lions, manatees, and
      dinosaurs. During the game users may travel where they please and interact with what they
      choose. The virtual reality device is equipped with head-tracking software that allows the
      user to choose direction by looking around. The entire interior and exterior of the headset
      will be cleaned with alcohol-based wipes after each use. Alcohol will be used since it is
      generally well-tolerated on human skin, and since it evaporates quickly. The headset will be
      dried in the open air for a minimum of two minutes between each subject's use.

      Those not using the virtual reality will still wear a headset that will simply be turned off.
      This is to ensure that any significant change noted with the virtual reality is due to the
      use of virtual reality itself, and not simply due to "blindfolding" the patient during the
      procedure.

      As some patients experiencing anxiety may be tempted to move during the procedure, lab
      personnel will instruct participants to remain still during venipuncture. Participants will
      be advised that they may take breaks as needed if anxiety becomes overwhelming.

      After undergoing the procedure, each participant will be asked to fill out the postprocedure
      questionnaire and return it to the study team member present in the lab room, who will clean
      the headset as the participant completes the questionnaire. This questionnaire assesses the
      patient's pain intensity and level of anxiety with the VAS similar to the VAS assessing pain,
      as well as the patient's satisfaction with the visit which will be measured utilizing a
      Likert scale for individual questions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Procedural Pain
time frame: 2 months
description: Determine if use of Oculus Go headset reduces procedural pain perception utilizing the visual analog scale, which measures pain on a linear scale from 0 to 100 millimeters, with 0 being no pain and 100 being maximum pain
measure: Procedural Anxiety
time frame: 2 months
description: Determine if use of Oculus Go headset reduces procedural anxiety utilizing the visual analog scale, which measures anxiety on a linear scale from 0 to 100 millimeters, with 0 being no anxiety and 100 being maximum anxiety
arm group label: Standard care venipuncture with additional of virtual reality
arm group type: Experimental
description: Patients undergoing blood draw while interacting with VR application Ocean Rift while wearing Oculus Go headset
arm group label: Standard care venipuncture without addition of virtual reality
arm group type: No Intervention
description: Patients undergoing blood draw while wearing Oculus Go headset that is turned off
intervention type: Device
intervention name: Oculus Go headset with Ocean Rift application
description: Information already included in arm description
arm group label: Standard care venipuncture with additional of virtual reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew J Perdue, PA
role: Principal Investigator
affiliation: C.R.Darnall Army Medical Center
facility: 
country: United States
url: https://download.militaryonesource.mil/12038/MOS/Reports/2018-demographics-report.pdf
description: 2018 Demographics Report: Profile of the Military Community
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PMID: 30618938
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PMID: 15102157
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PMID: 14525749
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PMID: 19786489
citation: Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014 Dec;30(12):1089-98. doi: 10.1097/AJP.0000000000000064.
PMID: 24535053
citation: Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
PMID: 16640481
citation: Gold JI, Belmont KA, Thomas DA. The neurobiology of virtual reality pain attenuation. Cyberpsychol Behav. 2007 Aug;10(4):536-44. doi: 10.1089/cpb.2007.9993.
PMID: 17711362
citation: Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
PMID: 11587113
citation: Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.
PMID: 15327820
citation: Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
PMID: 21779307
citation: Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
PMID: 20691523
citation: Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
PMID: 11719741
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PMID: 24892202
citation: Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.
PMID: 31889358
responsible party type: Principal Investigator
investigator affiliation: C.R.Darnall Army Medical Center
investigator full name: Matthew J. Perdue, DSc, PA-C
investigator title: Fellow, US Army-Baylor DSc Emergency Medicine PA Studies, Principal Investigator
mesh term: Pain, Procedural
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 