<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/NCT04479735</url>
  </required_header>
  <id_info>
    <org_study_id>2020-11200</org_study_id>
    <nct_id>NCT04479735</nct_id>
  </id_info>
  <brief_title>Virtual Reality Goggle Utilization for Venipuncture Distraction</brief_title>
  <official_title>Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore 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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on&#xD;
      perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We&#xD;
      will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5%&#xD;
      cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus&#xD;
      virtual reality goggles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to&#xD;
      child life rounds and subsequently ask the health care providers if there are any patients&#xD;
      that are not developmentally or physically appropriate to use the VR equipment. They will&#xD;
      then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see&#xD;
      appendix A &amp; B). Patients aged 12-17 years old who are able to read the form will be asked to&#xD;
      fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to&#xD;
      read the form will be read the assent form to ensure verbal assent. Those patients who&#xD;
      consent to the study will be randomized to a VR arm and non VR arm using computer generated&#xD;
      randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have&#xD;
      consented to the study by the patient's nurse if they don't already have it applied. After&#xD;
      consent and assurance of topical anesthetic application, a brief demographic questionnaire&#xD;
      (see appendix D) will also be completed. For efficiency and feasibility, two study personnel&#xD;
      will screen and consent families, assist with VR set up and removal, and conduct post&#xD;
      procedure assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2021</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>randomized non blinded study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Perceived Pain: scale</measure>
    <time_frame>Approximately 1 hour prior to venipuncture and again immediately after venipuncture.</time_frame>
    <description>change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high &quot;number&quot; indicating worse pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety Scores</measure>
    <time_frame>Approximately 1 hour prior to venipuncture and again immediately after venipuncture.</time_frame>
    <description>Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Approximately 1 hour prior to venipuncture and again immediate after venipuncture.</time_frame>
    <description>Change in HR for patients on cardiac monitor pre/post venipuncture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of simulator sickness</measure>
    <time_frame>Approximately 1 hour prior to venipuncture and again immediately after venipuncture</time_frame>
    <description>Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pain, Procedural</condition>
  <arm_group>
    <arm_group_label>VR goggle with venipuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no VR goggle with venipuncture</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Goggles</intervention_name>
    <description>Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.</description>
    <arm_group_label>VR goggle with venipuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are&#xD;
        scheduled for a venipuncture during morning phlebotomy rounds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients developmentally or physically not appropriate to use the VR equipment as&#xD;
        determined by their parent, guardian or healthcare provider, if there is discomfort related&#xD;
        to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head),&#xD;
        patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19&#xD;
        that can't reliably be disinfected.&#xD;
&#xD;
        Patient (&gt;18) or Parent or guardian (for patient &lt; 18) that does not speak English, Spanish&#xD;
        or Arabic will be excluded.&#xD;
&#xD;
        If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from&#xD;
        the study.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney A McNamara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Courtney A McNamara, MD</last_name>
    <phone>540 514 4389</phone>
    <email>comcnama@montefiore.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katherine O'Connor, MD</last_name>
    <phone>(917) 776-0512</phone>
    <email>koconnor@montefiore.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</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/NCT04479735
org study id: 2020-11200
nct id: NCT04479735
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on
      perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We
      will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5%
      cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus
      virtual reality goggles.
Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to
      child life rounds and subsequently ask the health care providers if there are any patients
      that are not developmentally or physically appropriate to use the VR equipment. They will
      then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see
      appendix A & B). Patients aged 12-17 years old who are able to read the form will be asked to
      fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to
      read the form will be read the assent form to ensure verbal assent. Those patients who
      consent to the study will be randomized to a VR arm and non VR arm using computer generated
      randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have
      consented to the study by the patient's nurse if they don't already have it applied. After
      consent and assurance of topical anesthetic application, a brief demographic questionnaire
      (see appendix D) will also be completed. For efficiency and feasibility, two study personnel
      will screen and consent families, assist with VR set up and removal, and conduct post
      procedure assessment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized non blinded study
primary purpose: Other
masking: None (Open Label)
measure: Change in Perceived Pain: scale
time frame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture.
description: change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high "number" indicating worse pain.
measure: Anxiety Scores
time frame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture.
description: Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm.
measure: Heart Rate
time frame: Approximately 1 hour prior to venipuncture and again immediate after venipuncture.
description: Change in HR for patients on cardiac monitor pre/post venipuncture
measure: Level of simulator sickness
time frame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture
description: Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome)
arm group label: VR goggle with venipuncture
arm group type: Experimental
description: Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.
arm group label: no VR goggle with venipuncture
arm group type: No Intervention
description: Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.
intervention type: Device
intervention name: Virtual Reality Goggles
description: Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.
arm group label: VR goggle with venipuncture
criteria: 
gender: All
minimum age: 5 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Courtney A McNamara, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
last name: Courtney A McNamara, MD
phone: 540 514 4389
email: comcnama@montefiore.org
last name: Katherine O'Connor, MD
phone: (917) 776-0512
email: koconnor@montefiore.org
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Pain, Procedural
sharing ipd: No