<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/NCT03304769</url>
  </required_header>
  <id_info>
    <org_study_id>ASalinas</org_study_id>
    <nct_id>NCT03304769</nct_id>
  </id_info>
  <brief_title>Virtual Reality Distraction During Pediatric Intravenous Line Placement</brief_title>
  <official_title>Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seton Healthcare Family</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</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>
      This study aims to prospectively investigate the use of virtual reality headsets on the&#xD;
      placement of IVs in a pediatric emergency department, by comparing the first stick success&#xD;
      rate, total number of attempts, and the time to successful IV placement between patients who&#xD;
      use virtual reality headset technology during the placement and those who receive the&#xD;
      standard of care IV placement when child life ( individuals with special training in aiding&#xD;
      and augmenting pediatric coping skills) is not available. The investigators will also compare&#xD;
      the patient and parent perception of pain and anxiety associated with the IV placement in&#xD;
      both study groups. Finally, by detailing which medications have been given prior to use of&#xD;
      the VR for IV placement the investigators may evaluate for possible synergistic effects of VR&#xD;
      with prior medication administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children often describe procedures involving needles as the most stressful portion of the&#xD;
      hospital experience. 1,2 Many studies involving the perception of pain have highlighted the&#xD;
      importance of attention for the perception of pain, and, conversely, the benefit of&#xD;
      distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been&#xD;
      shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a&#xD;
      number of different ways. 5,6 While small studies have demonstrated the use of VR to be&#xD;
      effective in diminishing pain during intravenous (IV) placement for outpatient imaging in&#xD;
      pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR&#xD;
      during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR&#xD;
      during venipuncture and IV placement also frequently focus on self-reported or&#xD;
      parent-reported pain, rather than objectively quantifying number of IV sticks and time to&#xD;
      successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have&#xD;
      not been well-established, with some studies citing benefits only in patients over 10 years&#xD;
      of age, and others showing improvements in all age groups.7,9,10&#xD;
&#xD;
      This study aims to prospectively investigate the use of virtual reality headsets on the&#xD;
      placement of IVs in a pediatric emergency department, by comparing the first stick success&#xD;
      rate, total number of attempts, and the time to successful IV placement between patients who&#xD;
      use virtual reality headset technology during the placement and those who receive the&#xD;
      standard of care IV placement when child life ( individuals with special training in aiding&#xD;
      and augmenting pediatric coping skills) is not available. The investigators will also compare&#xD;
      the patient and parent perception of pain and anxiety associated with the IV placement in&#xD;
      both study groups. Finally, by detailing which medications have been given prior to use of&#xD;
      the VR for IV placement the investigators may evaluate for possible synergistic effects of VR&#xD;
      with prior medication administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Selected from a single-site level one pediatric emergency department. Pediatric patients aged 4-17 years requiring an IV. Random number generator used to decide which patients will be using VR and which will have standard IV placement</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful IV placement with first attempt</measure>
    <time_frame>6 months</time_frame>
    <description>success in first attempt in VR group vs non VR group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of attempts before successfully establishing IV</measure>
    <time_frame>6 months</time_frame>
    <description>number of attempts before successful IV placement in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to establishing successful IV</measure>
    <time_frame>6 months</time_frame>
    <description>time to establishing successful IV in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre vs Post FACES revised pain scale parents</measure>
    <time_frame>6 months</time_frame>
    <description>Pre vs Post FACES pain scale in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre vs Post FACES revised pain Scale patients</measure>
    <time_frame>6 months</time_frame>
    <description>Pre vs Post FACES pain scale in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre vs Post Likert-Type Anxiety Scale - parents</measure>
    <time_frame>6 months</time_frame>
    <description>Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre vs Post Likert-Type Anxiety Scale- patients</measure>
    <time_frame>6 months</time_frame>
    <description>Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>age range of patients that tolerate VR</measure>
    <time_frame>6 months</time_frame>
    <description>Which of evaluated age range of 4-17 years tolerate VR placement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Pediatric IV Placement</condition>
  <condition>Virtual Reality Distraction</condition>
  <arm_group>
    <arm_group_label>IV placement no Virtual reality</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient will have IV placed in traditional manner, with no virtual reality headset</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV placement with Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will have IV placed with Virtual Reality headset distraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.</description>
    <arm_group_label>IV placement with Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 4-17 years&#xD;
&#xD;
          -  Requiring IV placement&#xD;
&#xD;
          -  Child Life unavailable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous enrollment in the study&#xD;
&#xD;
          -  Physically/ developmentally unable to tolerate headset&#xD;
&#xD;
          -  Skin/eye pathology&#xD;
&#xD;
          -  Critically ill patient&#xD;
&#xD;
          -  Language other than English or Spanish&#xD;
&#xD;
          -  Student Nurse placing IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anna K Schlechter, MD</last_name>
    <phone>512-662-6512</phone>
    <email>anna.schlechter@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthew Wilkinson, MD</last_name>
    <phone>512-547-8362</phone>
    <email>mhwilkinson@ascension.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Wilkinson, MD</last_name>
      <phone>512-547-8362</phone>
      <email>mhwilkinson@ascension.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality Distraction</keyword>
  <keyword>Pediatric IV placement</keyword>
  <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/NCT03304769
org study id: ASalinas
nct id: NCT03304769
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to prospectively investigate the use of virtual reality headsets on the
      placement of IVs in a pediatric emergency department, by comparing the first stick success
      rate, total number of attempts, and the time to successful IV placement between patients who
      use virtual reality headset technology during the placement and those who receive the
      standard of care IV placement when child life ( individuals with special training in aiding
      and augmenting pediatric coping skills) is not available. The investigators will also compare
      the patient and parent perception of pain and anxiety associated with the IV placement in
      both study groups. Finally, by detailing which medications have been given prior to use of
      the VR for IV placement the investigators may evaluate for possible synergistic effects of VR
      with prior medication administration.
Children often describe procedures involving needles as the most stressful portion of the
      hospital experience. 1,2 Many studies involving the perception of pain have highlighted the
      importance of attention for the perception of pain, and, conversely, the benefit of
      distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been
      shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a
      number of different ways. 5,6 While small studies have demonstrated the use of VR to be
      effective in diminishing pain during intravenous (IV) placement for outpatient imaging in
      pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR
      during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR
      during venipuncture and IV placement also frequently focus on self-reported or
      parent-reported pain, rather than objectively quantifying number of IV sticks and time to
      successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have
      not been well-established, with some studies citing benefits only in patients over 10 years
      of age, and others showing improvements in all age groups.7,9,10

      This study aims to prospectively investigate the use of virtual reality headsets on the
      placement of IVs in a pediatric emergency department, by comparing the first stick success
      rate, total number of attempts, and the time to successful IV placement between patients who
      use virtual reality headset technology during the placement and those who receive the
      standard of care IV placement when child life ( individuals with special training in aiding
      and augmenting pediatric coping skills) is not available. The investigators will also compare
      the patient and parent perception of pain and anxiety associated with the IV placement in
      both study groups. Finally, by detailing which medications have been given prior to use of
      the VR for IV placement the investigators may evaluate for possible synergistic effects of VR
      with prior medication administration.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Selected from a single-site level one pediatric emergency department. Pediatric patients aged 4-17 years requiring an IV. Random number generator used to decide which patients will be using VR and which will have standard IV placement
primary purpose: Other
masking: None (Open Label)
measure: Successful IV placement with first attempt
time frame: 6 months
description: success in first attempt in VR group vs non VR group
measure: number of attempts before successfully establishing IV
time frame: 6 months
description: number of attempts before successful IV placement in VR group vs non VR group
measure: time to establishing successful IV
time frame: 6 months
description: time to establishing successful IV in VR group vs non VR group
measure: Pre vs Post FACES revised pain scale parents
time frame: 6 months
description: Pre vs Post FACES pain scale in VR group vs non VR group
measure: Pre vs Post FACES revised pain Scale patients
time frame: 6 months
description: Pre vs Post FACES pain scale in VR group vs non VR group
measure: Pre vs Post Likert-Type Anxiety Scale - parents
time frame: 6 months
description: Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
measure: Pre vs Post Likert-Type Anxiety Scale- patients
time frame: 6 months
description: Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
measure: age range of patients that tolerate VR
time frame: 6 months
description: Which of evaluated age range of 4-17 years tolerate VR placement
arm group label: IV placement no Virtual reality
arm group type: No Intervention
description: Patient will have IV placed in traditional manner, with no virtual reality headset
arm group label: IV placement with Virtual Reality
arm group type: Experimental
description: Patient will have IV placed with Virtual Reality headset distraction
intervention type: Device
intervention name: Virtual Reality
description: Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.
arm group label: IV placement with Virtual Reality
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna K Schlechter, MD
phone: 512-662-6512
email: anna.schlechter@gmail.com
last name: Matthew Wilkinson, MD
phone: 512-547-8362
email: mhwilkinson@ascension.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No