Virtual Reality Distraction During Pediatric Intravenous Line Placement

Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study

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 Overview

• Status: Unknown
• Conditions: Pediatric IV Placement; Virtual Reality Distraction
• Intervention / Treatment: Device: Virtual Reality

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
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center of Central Texas
      • Contact: Matthew Wilkinson, MD; Phone Number: 512-547-8362; Email: mhwilkinson@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful IV placement with first attempt	success in first attempt in VR group vs non VR group	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of attempts before successfully establishing IV	number of attempts before successful IV placement in VR group vs non VR group	6 months
time to establishing successful IV	time to establishing successful IV in VR group vs non VR group	6 months
Pre vs Post FACES revised pain scale parents	Pre vs Post FACES pain scale in VR group vs non VR group	6 months
Pre vs Post FACES revised pain Scale patients	Pre vs Post FACES pain scale in VR group vs non VR group	6 months
Pre vs Post Likert-Type Anxiety Scale - parents	Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group	6 months
Pre vs Post Likert-Type Anxiety Scale- patients	Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group	6 months
age range of patients that tolerate VR	Which of evaluated age range of 4-17 years tolerate VR placement	6 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Seton Healthcare Family

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Virtual Reality Distraction; Pediatric IV placement
• Other Study ID Numbers: ASalinas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No