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Virtual Reality Distraction During Pediatric Intravenous Line Placement

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03304769
Enrollment
116
Registered
2017-10-09
Start date
2017-09-28
Completion date
2018-01-31
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric IV Placement, Virtual Reality Distraction

Keywords

Virtual Reality Distraction, Pediatric IV placement

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.

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.

Interventions

DEVICEVirtual Reality

Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.

Sponsors

Seton Healthcare Family
CollaboratorOTHER
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Successful IV placement with first attempt6 monthssuccess in first attempt in VR group vs non VR group

Secondary

MeasureTime frameDescription
time to establishing successful IV6 monthstime to establishing successful IV in VR group vs non VR group
Pre vs Post FACES revised pain scale parents6 monthsPre vs Post FACES pain scale in VR group vs non VR group
Pre vs Post FACES revised pain Scale patients6 monthsPre vs Post FACES pain scale in VR group vs non VR group
number of attempts before successfully establishing IV6 monthsnumber of attempts before successful IV placement in VR group vs non VR group
Pre vs Post Likert-Type Anxiety Scale- patients6 monthsPre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
age range of patients that tolerate VR6 monthsWhich of evaluated age range of 4-17 years tolerate VR placement
Pre vs Post Likert-Type Anxiety Scale - parents6 monthsPre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group

Countries

United States

Contacts

Primary ContactAnna K Schlechter, MD
anna.schlechter@gmail.com512-662-6512
Backup ContactMatthew Wilkinson, MD
mhwilkinson@ascension.org512-547-8362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026