<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/NCT04469881</url>
  </required_header>
  <id_info>
    <org_study_id>HM20017126</org_study_id>
    <nct_id>NCT04469881</nct_id>
  </id_info>
  <brief_title>Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study</brief_title>
  <official_title>Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to test the safety, tolerability, and effectiveness of&#xD;
      watching streamed videos through virtual reality (VR) goggles during surgery.&#xD;
&#xD;
      The results of this study will be used to evaluate whether video-streaming services on VR&#xD;
      goggles are worthwhile additions to standard anesthesia care during total knee surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Usual anesthetic care for total knee replacement involves intravenous sedation as well as&#xD;
      spinal anesthesia. In this study, participants will receive usual care, and in addition, will&#xD;
      be asked to wear VR goggles once they arrive in the operating room. Participants will choose&#xD;
      from a selection of 10 shows and movies to watch for the duration of the surgery&#xD;
      (approximately 2 hours).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lost research staff - unable to enroll until new research staff is hired.&#xD;
  </why_stopped>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Actual">August 3, 2023</completion_date>
  <primary_completion_date type="Actual">August 3, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sedation requirement</measure>
    <time_frame>approximately 2 hours</time_frame>
    <description>Micrograms of propofol per kilogram per minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant pain rating</measure>
    <time_frame>24 hours</time_frame>
    <description>Average pain score measured immediately after surgery and every 4 hours afterwards for 24 hour. Pain will be rated on a 0 to 10 scale with 0 being no pain and 10 being the worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first opioid request</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Time in minutes between leaving the operating room and administration of first oral opioid.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wear VR glasses and watch movies during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VR</intervention_name>
    <description>Participants will be asked to do the following things:&#xD;
Wear VR goggles for the duration of the surgery&#xD;
Answer questions about their experience with the VR goggles&#xD;
Give permission for the researchers to collect information about the anesthesia medications used, pain medications used, and reported pain scores during the surgery and during recovery in the hospital</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. undergoing a primary elective total knee replacement by one of the orthopedic joint&#xD;
             surgeons at Virginia Commonwealth University Medical Center&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. eligible for spinal anesthesia&#xD;
&#xD;
          4. mentally capable of understanding instructions on how to request anesthesia medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. identified as a member of regulated vulnerable population&#xD;
&#xD;
          2. ineligibility for spinal anesthesia&#xD;
&#xD;
          3. morbid obesity (body mass index greater than 40)&#xD;
&#xD;
          4. allergy to propofol or midazolam&#xD;
&#xD;
          5. pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours&#xD;
             (over 60 morphine miligram equivalents per day)&#xD;
&#xD;
          6. daily benzodiazepine consumption&#xD;
&#xD;
          7. history of alcohol or recreational drug abuse&#xD;
&#xD;
          8. hearing or visually impaired individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryant Tran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04469881
org study id: HM20017126
nct id: NCT04469881
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to test the safety, tolerability, and effectiveness of
      watching streamed videos through virtual reality (VR) goggles during surgery.

      The results of this study will be used to evaluate whether video-streaming services on VR
      goggles are worthwhile additions to standard anesthesia care during total knee surgery.
Usual anesthetic care for total knee replacement involves intravenous sedation as well as
      spinal anesthesia. In this study, participants will receive usual care, and in addition, will
      be asked to wear VR goggles once they arrive in the operating room. Participants will choose
      from a selection of 10 shows and movies to watch for the duration of the surgery
      (approximately 2 hours).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Sedation requirement
time frame: approximately 2 hours
description: Micrograms of propofol per kilogram per minute
measure: Participant pain rating
time frame: 24 hours
description: Average pain score measured immediately after surgery and every 4 hours afterwards for 24 hour. Pain will be rated on a 0 to 10 scale with 0 being no pain and 10 being the worst pain imaginable.
measure: Opioid consumption
time frame: 24 hours
description: Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.
measure: Time to first opioid request
time frame: up to 24 hours
description: Time in minutes between leaving the operating room and administration of first oral opioid.
arm group label: Virtual Reality
arm group type: Experimental
description: Wear VR glasses and watch movies during surgery
intervention type: Behavioral
intervention name: VR
description: Participants will be asked to do the following things:
Wear VR goggles for the duration of the surgery
Answer questions about their experience with the VR goggles
Give permission for the researchers to collect information about the anesthesia medications used, pain medications used, and reported pain scores during the surgery and during recovery in the hospital
arm group label: Virtual Reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bryant Tran, MD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No