Clinical trial NCT03304769: Virtual Reality Distraction During Pediatric Intravenous Line Placement
Official title: Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric IV Placement
Virtual Reality Distraction
Keywords: Virtual Reality Distraction
Pediatric IV placement
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Seton Healthcare Family
First posted: 2017-10-09
Enrollment: 116
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.

Eligibility 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

Primary outcomes:
measure: Successful IV placement with first attempt
timeFrame: 6 months
Secondary outcomes:
measure: number of attempts before successfully establishing IV
timeFrame: 6 months
measure: time to establishing successful IV
timeFrame: 6 months
measure: Pre vs Post FACES revised pain scale parents
timeFrame: 6 months
measure: Pre vs Post FACES revised pain Scale patients
timeFrame: 6 months
measure: Pre vs Post Likert-Type Anxiety Scale - parents
timeFrame: 6 months
measure: Pre vs Post Likert-Type Anxiety Scale- patients
timeFrame: 6 months
measure: age range of patients that tolerate VR
timeFrame: 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
References: