<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/NCT03787147</url>
  </required_header>
  <id_info>
    <org_study_id>2018-9613</org_study_id>
    <nct_id>NCT03787147</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)</brief_title>
  <acronym>VR adult</acronym>
  <official_title>Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A three-group parallel randomized controlled trial to evaluate the efficacy of virtual&#xD;
      reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients&#xD;
      undergoing Spinal Injections (SI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Never started the study cause of the lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 30, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
    <masking_description>The sealed envelope is randomized and blinded so no one will know which group the participant falls and its revealed only after the participant opens the sealed envelope.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity as measured by the Visual Analog Scale</measure>
    <time_frame>Immediately after receiving spinal injection</time_frame>
    <description>Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS). The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety Level as measured by the Visual Facial Anxiety Scale</measure>
    <time_frame>Immediately after receiving spinal injection</time_frame>
    <description>Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS). The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate as measured by the Empatica E4 wristband</measure>
    <time_frame>Baseline, during and Immediately after the procedure</time_frame>
    <description>The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure as measured by the Empatica E4 wristband</measure>
    <time_frame>Baseline, during and Immediately after the procedure</time_frame>
    <description>The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure as measured by the Empatica E4 wristband</measure>
    <time_frame>Baseline, during and Immediately after the procedure</time_frame>
    <description>The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathetic skin response as measured by the Empatica E4 wristband</measure>
    <time_frame>Baseline, during and Immediately after the procedure</time_frame>
    <description>The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Sympathetic skin response before, during and after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature as measured by the Empatica E4 wristband</measure>
    <time_frame>Baseline, during and Immediately after the procedure</time_frame>
    <description>The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Temperature before, during and after the procedure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Injection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adults receiving Spinal Injection(SI) without Virtual Reality(VR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Google Cardboard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oculus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adults receiving SI while using VR with Oculus Rift.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Google Cardboard</intervention_name>
    <description>Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.</description>
    <arm_group_label>Google Cardboard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oculus</intervention_name>
    <description>Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.</description>
    <arm_group_label>Oculus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride</intervention_name>
    <description>All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.</description>
    <arm_group_label>Google Cardboard</arm_group_label>
    <arm_group_label>Oculus</arm_group_label>
    <arm_group_label>Spinal Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.</description>
    <arm_group_label>Google Cardboard</arm_group_label>
    <arm_group_label>Oculus</arm_group_label>
    <arm_group_label>Spinal Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult requiring Spinal Injections&#xD;
&#xD;
          -  Adult &gt; 18years&#xD;
&#xD;
          -  Adults with intact vision who can attend VR intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone &lt; 18 years&#xD;
&#xD;
          -  Adults who are not attentive to VR secondary to poor concentration, poor cognition to&#xD;
             external stimuli&#xD;
&#xD;
          -  Adults who request moderate IV sedation&#xD;
&#xD;
          -  Adults with photic-induced seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed Wahezi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
    <investigator_full_name>Sayed Wahezi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Spinal Injection</keyword>
  <keyword>Adult</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Google cardboard</keyword>
  <keyword>Oculus</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT03787147
org study id: 2018-9613
nct id: NCT03787147
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A three-group parallel randomized controlled trial to evaluate the efficacy of virtual
      reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients
      undergoing Spinal Injections (SI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: The sealed envelope is randomized and blinded so no one will know which group the participant falls and its revealed only after the participant opens the sealed envelope.
measure: Pain intensity as measured by the Visual Analog Scale
time frame: Immediately after receiving spinal injection
description: Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS). The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).
measure: Anxiety Level as measured by the Visual Facial Anxiety Scale
time frame: Immediately after receiving spinal injection
description: Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS). The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).
measure: Heart rate as measured by the Empatica E4 wristband
time frame: Baseline, during and Immediately after the procedure
description: The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.
measure: Systolic Blood Pressure as measured by the Empatica E4 wristband
time frame: Baseline, during and Immediately after the procedure
description: The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
measure: Diastolic Blood Pressure as measured by the Empatica E4 wristband
time frame: Baseline, during and Immediately after the procedure
description: The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
measure: Sympathetic skin response as measured by the Empatica E4 wristband
time frame: Baseline, during and Immediately after the procedure
description: The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Sympathetic skin response before, during and after the procedure.
measure: Temperature as measured by the Empatica E4 wristband
time frame: Baseline, during and Immediately after the procedure
description: The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization. Empatica E4 wristband is worn by the participant throughout the procedure to measure Temperature before, during and after the procedure.
arm group label: Spinal Injection
arm group type: Other
description: Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
arm group label: Google Cardboard
arm group type: Active Comparator
description: Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
arm group label: Oculus
arm group type: Active Comparator
description: Adults receiving SI while using VR with Oculus Rift.
intervention type: Device
intervention name: Google Cardboard
description: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
arm group label: Google Cardboard
intervention type: Device
intervention name: Oculus
description: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
arm group label: Oculus
intervention type: Drug
intervention name: Lidocaine Hydrochloride
description: All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
arm group label: Google Cardboard
arm group label: Oculus
arm group label: Spinal Injection
intervention type: Drug
intervention name: Bupivacaine
description: All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
arm group label: Google Cardboard
arm group label: Oculus
arm group label: Spinal Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sayed Wahezi, MD
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein College of Medicine
investigator full name: Sayed Wahezi
investigator title: Principal Investigator
mesh term: Lidocaine
mesh term: Bupivacaine
sharing ipd: No