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Virtual Reality Distraction During Pediatric Intravenous Line Placement

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ClinicalTrials.gov Identifier: NCT03304769
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Seton Healthcare Family
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pediatric IV Placement Virtual Reality Distraction Device: Virtual Reality Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
No Intervention: IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
Experimental: IV placement with Virtual Reality
Patient will have IV placed with Virtual Reality headset distraction
Device: Virtual Reality
Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.




Primary Outcome Measures :
  1. Successful IV placement with first attempt [ Time Frame: 6 months ]
    success in first attempt in VR group vs non VR group


Secondary Outcome Measures :
  1. number of attempts before successfully establishing IV [ Time Frame: 6 months ]
    number of attempts before successful IV placement in VR group vs non VR group

  2. time to establishing successful IV [ Time Frame: 6 months ]
    time to establishing successful IV in VR group vs non VR group

  3. Pre vs Post FACES revised pain scale parents [ Time Frame: 6 months ]
    Pre vs Post FACES pain scale in VR group vs non VR group

  4. Pre vs Post FACES revised pain Scale patients [ Time Frame: 6 months ]
    Pre vs Post FACES pain scale in VR group vs non VR group

  5. Pre vs Post Likert-Type Anxiety Scale - parents [ Time Frame: 6 months ]
    Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group

  6. Pre vs Post Likert-Type Anxiety Scale- patients [ Time Frame: 6 months ]
    Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group

  7. age range of patients that tolerate VR [ Time Frame: 6 months ]
    Which of evaluated age range of 4-17 years tolerate VR placement



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient aged 4-17 years
  • Requiring IV placement
  • Child Life unavailable

Exclusion Criteria:

  • Previous enrollment in the study
  • Physically/ developmentally unable to tolerate headset
  • Skin/eye pathology
  • Critically ill patient
  • Language other than English or Spanish
  • Student Nurse placing IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304769


Contacts
Contact: Anna K Schlechter, MD 512-662-6512 anna.schlechter@gmail.com
Contact: Matthew Wilkinson, MD 512-547-8362 mhwilkinson@ascension.org

Locations
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Matthew Wilkinson, MD    512-547-8362    mhwilkinson@ascension.org   
Sponsors and Collaborators
University of Texas at Austin
Seton Healthcare Family

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03304769     History of Changes
Other Study ID Numbers: ASalinas
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas at Austin:
Virtual Reality Distraction
Pediatric IV placement