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Clinical Trial Summary

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.


Clinical Trial Description

Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement). Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures. While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach. The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center. Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR. Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure. In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions. Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04942561
Study type Interventional
Source Children's Hospital Los Angeles
Contact
Status Completed
Phase N/A
Start date April 12, 2017
Completion date July 24, 2019

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