<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/NCT04437173</url>
  </required_header>
  <id_info>
    <org_study_id>1480456</org_study_id>
    <nct_id>NCT04437173</nct_id>
  </id_info>
  <brief_title>Pain Procedures and Anxiolysis Via Distraction With Virtual Reality</brief_title>
  <acronym>PAIN-VR</acronym>
  <official_title>Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety&#xD;
      patients undergoing interventional pain procedures compared to placebo/active placebo or a&#xD;
      non VR option.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">February 9, 2022</completion_date>
  <primary_completion_date type="Actual">February 9, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety Score</measure>
    <time_frame>Immediately before procedure and immediately after procedure.</time_frame>
    <description>State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Immediately before procedure, during procedure, and immediately after procedure</time_frame>
    <description>Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation Requirements</measure>
    <time_frame>During course of procedure</time_frame>
    <description>Amount of benzodiazepines and opioid medications given</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Impression of Change</measure>
    <time_frame>Immediately after procedure</time_frame>
    <description>Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Experience Satisfaction</measure>
    <time_frame>Immediately after procedure</time_frame>
    <description>Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Virtual Reality</condition>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo interventional pain procedure with virtual reality distraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergo interventional pain procedure without virtual reality distraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Headset Distraction</intervention_name>
    <description>Patient wears a virtual reality headset during interventional pain procedure</description>
    <arm_group_label>Virtual Reality Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 18 years old, who are referred to University of California Davis&#xD;
             Pain Medicine Clinic and require an interventional pain procedure&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Having the ability to understand oral and written instructions&#xD;
&#xD;
          -  Willing to fill out psychometric surveys.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients who have high risk of motion sickness, seizure disorder, or visual/hearing&#xD;
             impairment&#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>Naileshni Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Jung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Interventional Pain Clinic</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</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>Anxiety Disorders</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/NCT04437173
org study id: 1480456
nct id: NCT04437173
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety
      patients undergoing interventional pain procedures compared to placebo/active placebo or a
      non VR option.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety Score
time frame: Immediately before procedure and immediately after procedure.
description: State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)
measure: Pain Score
time frame: Immediately before procedure, during procedure, and immediately after procedure
description: Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
measure: Sedation Requirements
time frame: During course of procedure
description: Amount of benzodiazepines and opioid medications given
measure: Global Impression of Change
time frame: Immediately after procedure
description: Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)
measure: Patient Experience Satisfaction
time frame: Immediately after procedure
description: Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
arm group label: Virtual Reality Arm
arm group type: Experimental
description: Patients undergo interventional pain procedure with virtual reality distraction
arm group label: No Intervention Arm
arm group type: No Intervention
description: Patients undergo interventional pain procedure without virtual reality distraction
intervention type: Device
intervention name: Virtual Reality Headset Distraction
description: Patient wears a virtual reality headset during interventional pain procedure
arm group label: Virtual Reality Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naileshni Singh, MD
role: Principal Investigator
affiliation: University of California, Davis
last name: John Sun, MD
role: Principal Investigator
affiliation: University of California, Davis
last name: Michael Jung, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No