<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/NCT04416555</url>
  </required_header>
  <id_info>
    <org_study_id>19-769</org_study_id>
    <nct_id>NCT04416555</nct_id>
  </id_info>
  <brief_title>Virtual Reality Distraction for Reduction</brief_title>
  <official_title>Virtual Reality Distraction for Reduction in Acute Postoperative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      Using a randomized controlled design, the investigators goal is to estimate the effect of VR&#xD;
      on postoperative analgesia and opioid consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the investigators propose to test the primary hypothesis that the use of&#xD;
      AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1&#xD;
      point difference considered clinically important) compared to sham treatment on a 0-10 scale&#xD;
      15 minutes after each use in the first 48 hours after surgery or hospital discharge,&#xD;
      whichever comes first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">May 3, 2022</completion_date>
  <primary_completion_date type="Actual">April 25, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Single (Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>From the end of surgery until 48 hours after surgery or discharge, whichever comes first</time_frame>
    <description>The investigators will assess pain using NRS scores (0-10, with 10 being worst)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total opioid consumption</measure>
    <time_frame>Within the first 72 hours.</time_frame>
    <description>the investigators will measure total opioid consumption converted to morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time weighted average pain score</measure>
    <time_frame>Every 4 hours by standard of care during the first 48 hours after surgery or hospital discharge, whichever comes first using NRS scores (0-10, with 10 being worst).</time_frame>
    <description>The investigators will capture all pain scores measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of video system usability</measure>
    <time_frame>Once after the last assessment or hospital discharge, whichever comes first.</time_frame>
    <description>Patient's perception of video system usability will be assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post discharge analgesia.</measure>
    <time_frame>One week (7days) after hospital discharge</time_frame>
    <description>Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>VR googles using exposure sham program</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The study groups will receive VR googles and the sham program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR googles and the real VR program experience.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study group will receive the VR googles and the real VR program experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo comparator: VR googles and the non reality experience</intervention_name>
    <description>parallel assignment (this arm will receive a static presentation in the same device)</description>
    <arm_group_label>VR googles using exposure sham program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Comparator: VR googles and the real VR program to enter act with and experience</intervention_name>
    <description>Parallel assignment (this arm will receive the full immersive virtual reality experience</description>
    <arm_group_label>VR googles and the real VR program experience.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology Physical Status 1-3;&#xD;
&#xD;
          -  Scheduled for elective, primary total hip arthroplasty;&#xD;
&#xD;
          -  Anticipated hospitalization of at least 1 night;&#xD;
&#xD;
          -  Expected to require parenteral opioids for postoperative pain;&#xD;
&#xD;
          -  Able to use IV PCA systems.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  History of chronic pain or care by a pain management specialist;&#xD;
&#xD;
          -  Use of more than 30 mg/day of oral oxycodone (or equivalent);&#xD;
&#xD;
          -  Greater than 12 weeks of current and continued opioid use;&#xD;
&#xD;
          -  History of seizures, epilepsy, motion sickness, stroke, dementia;&#xD;
&#xD;
          -  Non-English speaking;&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding;&#xD;
&#xD;
          -  History of substance use disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabry Ayad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 13, 2023</submitted>
    <returned>August 23, 2023</returned>
  </pending_results>
  <!-- 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/NCT04416555
org study id: 19-769
nct id: NCT04416555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Using a randomized controlled design, the investigators goal is to estimate the effect of VR
      on postoperative analgesia and opioid consumption.
Specifically, the investigators propose to test the primary hypothesis that the use of
      AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1
      point difference considered clinically important) compared to sham treatment on a 0-10 scale
      15 minutes after each use in the first 48 hours after surgery or hospital discharge,
      whichever comes first.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: Single (Outcomes Assessor)
measure: Pain Scores
time frame: From the end of surgery until 48 hours after surgery or discharge, whichever comes first
description: The investigators will assess pain using NRS scores (0-10, with 10 being worst)
measure: Total opioid consumption
time frame: Within the first 72 hours.
description: the investigators will measure total opioid consumption converted to morphine milligram equivalents (MME).
measure: Time weighted average pain score
time frame: Every 4 hours by standard of care during the first 48 hours after surgery or hospital discharge, whichever comes first using NRS scores (0-10, with 10 being worst).
description: The investigators will capture all pain scores measurements
measure: Perception of video system usability
time frame: Once after the last assessment or hospital discharge, whichever comes first.
description: Patient's perception of video system usability will be assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.
measure: Post discharge analgesia.
time frame: One week (7days) after hospital discharge
description: Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.
arm group label: VR googles using exposure sham program
arm group type: Placebo Comparator
description: The study groups will receive VR googles and the sham program
arm group label: VR googles and the real VR program experience.
arm group type: Active Comparator
description: The study group will receive the VR googles and the real VR program experience.
intervention type: Device
intervention name: Placebo comparator: VR googles and the non reality experience
description: parallel assignment (this arm will receive a static presentation in the same device)
arm group label: VR googles using exposure sham program
intervention type: Device
intervention name: Active Comparator: VR googles and the real VR program to enter act with and experience
description: Parallel assignment (this arm will receive the full immersive virtual reality experience
arm group label: VR googles and the real VR program experience.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sabry Ayad, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
submitted: August 13, 2023
returned: August 23, 2023