<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/NCT03801616</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00055330</org_study_id>
    <nct_id>NCT03801616</nct_id>
  </id_info>
  <brief_title>Virtual Reality After Breast Reconstruction Surgery</brief_title>
  <acronym>VR4BR</acronym>
  <official_title>VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of virtual reality (VR) non-opioid management for women undergoing&#xD;
      mastectomy and implant-based reconstruction. Study participants will receive specialized VR&#xD;
      interventions, administered via VR headsets, to manage pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to estimate the effect of utilizing VR on reducing&#xD;
      opioid use in study participants undergoing mastectomy with implant-based reconstruction&#xD;
      compared to the control group. Investigators will follow patients throughout the course of&#xD;
      their hospitalization and monitor outcomes including pain levels, medication requests, and&#xD;
      satisfaction.&#xD;
&#xD;
      Eligible participants will receive a VR headset and instructed to use the VR every time they&#xD;
      feel pain and before asking for a pain medication. They can take pain medications, if they&#xD;
      choose to do so. At their post-op visit, study participants will be interviewed and asked&#xD;
      questions regarding their experience with VR.&#xD;
&#xD;
      Pain level and medication use will be compared with similar individuals who undergo the same&#xD;
      procedure but are not provided with a VR headset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine Milligram Equivalents</measure>
    <time_frame>During hospitalization until discharge, approximately 2 days</time_frame>
    <description>Opioid usage is defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference in pain</measure>
    <time_frame>From operation to discharge, approximately 2 days</time_frame>
    <description>Pain collected via ecological momentary assessment by hospital staff. Study participants will be asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is &quot;no pain&quot; and 10 is &quot;worst imaginable pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference in length of stay</measure>
    <time_frame>During hospitalization until discharge, approximately 2 days</time_frame>
    <description>Length of stay will be collected via hospital records</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Non-Opioid Pain Management</condition>
  <condition>Virtual Reality</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Every participant is provided with a VR headset</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Virtual Reality in controlling pain</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Women who plan to undergo mastectomy and implant-based reconstruction&#xD;
&#xD;
          -  Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
          -  Able to read and comprehend English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent&#xD;
             use of VR headset and software&#xD;
&#xD;
          -  Sensitivity to flashing light&#xD;
&#xD;
          -  Diagnosis of motion sickness&#xD;
&#xD;
          -  Pregnancy or a medical condition where the study participant is prone to frequent&#xD;
             nausea or dizziness&#xD;
&#xD;
          -  Current or recent (less than 6 months) use of opioids&#xD;
&#xD;
          -  Individuals with psychiatric disorders, including those with delirium or other&#xD;
             disorders that may involve hallucinations or psychosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Implant-based reconstruction after mastectomy is not common in males.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Alice Chung</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03801616
org study id: Pro00055330
nct id: NCT03801616
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing
      mastectomy and implant-based reconstruction. Study participants will receive specialized VR
      interventions, administered via VR headsets, to manage pain.
The primary objective of this study is to estimate the effect of utilizing VR on reducing
      opioid use in study participants undergoing mastectomy with implant-based reconstruction
      compared to the control group. Investigators will follow patients throughout the course of
      their hospitalization and monitor outcomes including pain levels, medication requests, and
      satisfaction.

      Eligible participants will receive a VR headset and instructed to use the VR every time they
      feel pain and before asking for a pain medication. They can take pain medications, if they
      choose to do so. At their post-op visit, study participants will be interviewed and asked
      questions regarding their experience with VR.

      Pain level and medication use will be compared with similar individuals who undergo the same
      procedure but are not provided with a VR headset.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Morphine Milligram Equivalents
time frame: During hospitalization until discharge, approximately 2 days
description: Opioid usage is defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.
measure: Mean difference in pain
time frame: From operation to discharge, approximately 2 days
description: Pain collected via ecological momentary assessment by hospital staff. Study participants will be asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain."
measure: Mean difference in length of stay
time frame: During hospitalization until discharge, approximately 2 days
description: Length of stay will be collected via hospital records
arm group label: Virtual Reality
arm group type: Experimental
description: Every participant is provided with a VR headset
intervention type: Device
intervention name: Virtual Reality
description: Virtual Reality in controlling pain
arm group label: Virtual Reality
criteria: 
gender: Female
gender based: Yes
gender description: Implant-based reconstruction after mastectomy is not common in males.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alice Chung, MD
role: Principal Investigator
affiliation: Cedars-Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Alice Chung
investigator title: Assistant Professor of Surgery
mesh term: Pain, Postoperative
sharing ipd: Undecided