<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/NCT04464304</url>
  </required_header>
  <id_info>
    <org_study_id>00020777</org_study_id>
    <nct_id>NCT04464304</nct_id>
  </id_info>
  <brief_title>Virtual Reality for Postoperative Pain Management</brief_title>
  <official_title>Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic&#xD;
      postoperative pain management among patients after head and neck surgery. Investigators will&#xD;
      assess differences in pain scores, analgesic use, and subjective patient experiences between&#xD;
      patients participating in a VR activity and patients participating in the same activity using&#xD;
      a smartphone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Management of postoperative pain after head and neck surgery is complex, and has received&#xD;
      increased attention to improve patient recovery and quality of life. Narcotic analgesics are&#xD;
      frequently utilized in postoperative pain management, but these have risks including nausea,&#xD;
      sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and&#xD;
      improve recovery, but medical comorbidities may contraindicate the use of certain&#xD;
      medications. Non-pharmacologic measures for postoperative pain control may provide novel and&#xD;
      cost-effective strategies to confront this complex issue.&#xD;
&#xD;
      Patients undergoing head and neck surgery will be randomly allocated to participate in an&#xD;
      immersive experience in VR, or to participate in a similar experience on a two-dimensional&#xD;
      screen using a smartphone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Actual">October 20, 2021</completion_date>
  <primary_completion_date type="Actual">October 20, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient-reported pain scores</measure>
    <time_frame>Up to 4 hours after intervention use</time_frame>
    <description>Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Average 24 hours after intervention use</time_frame>
    <description>Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>Up to 4 hours after intervention use</time_frame>
    <description>Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from &quot;1 = Strongly Disagree&quot; to &quot;5 = Strongly Agree.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Surgery</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Incision</condition>
  <condition>Otolaryngological Disease</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smartphone</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone</intervention_name>
    <description>Patients will participate in a similar game to the VR cohort, but will use a smartphone device.</description>
    <arm_group_label>Smartphone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality (Oculus Quest)</intervention_name>
    <description>Patients will participate in a game using VR.</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone head and neck surgery with an average pain score of 3 or&#xD;
             greater out of 10 during the 24 hours preceding the screening&#xD;
&#xD;
          -  Are able to provide informed consent&#xD;
&#xD;
          -  Are not in the intensive care unit (ICU)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms concerning for an active respiratory infection including fever, cough, and&#xD;
             shortness of breath or confirmed respiratory infection&#xD;
&#xD;
          -  Active eye discharge&#xD;
&#xD;
          -  Active nausea or vomiting&#xD;
&#xD;
          -  History of seizure, epilepsy, or hypersensitivity to flashing light&#xD;
&#xD;
          -  History of motion sickness or vertigo&#xD;
&#xD;
          -  Have wound dressings on the head or neck that prevent comfortable and safe use of the&#xD;
             virtual reality headset&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Ryan Li, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Otorhinolaryngologic Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464304
org study id: 00020777
nct id: NCT04464304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic
      postoperative pain management among patients after head and neck surgery. Investigators will
      assess differences in pain scores, analgesic use, and subjective patient experiences between
      patients participating in a VR activity and patients participating in the same activity using
      a smartphone.
Management of postoperative pain after head and neck surgery is complex, and has received
      increased attention to improve patient recovery and quality of life. Narcotic analgesics are
      frequently utilized in postoperative pain management, but these have risks including nausea,
      sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and
      improve recovery, but medical comorbidities may contraindicate the use of certain
      medications. Non-pharmacologic measures for postoperative pain control may provide novel and
      cost-effective strategies to confront this complex issue.

      Patients undergoing head and neck surgery will be randomly allocated to participate in an
      immersive experience in VR, or to participate in a similar experience on a two-dimensional
      screen using a smartphone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in patient-reported pain scores
time frame: Up to 4 hours after intervention use
description: Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.
measure: Opioid usage
time frame: Average 24 hours after intervention use
description: Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).
measure: Patient experience
time frame: Up to 4 hours after intervention use
description: Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from "1 = Strongly Disagree" to "5 = Strongly Agree."
arm group label: Virtual Reality
arm group type: Active Comparator
description: Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.
arm group label: Smartphone
arm group type: Sham Comparator
description: Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.
intervention type: Device
intervention name: Smartphone
description: Patients will participate in a similar game to the VR cohort, but will use a smartphone device.
arm group label: Smartphone
intervention type: Device
intervention name: Virtual Reality (Oculus Quest)
description: Patients will participate in a game using VR.
arm group label: Virtual Reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ryan Li, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Ryan Li, MD
investigator title: Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine
mesh term: Otorhinolaryngologic Diseases
mesh term: Pain, Postoperative
sharing ipd: No