Virtual Reality for IMMunisation (VRIMM) pain in young children: Results of a randomised controlled trial in general practice.

BACKGROUND AND OBJECTIVES: Virtual reality (VR) may be useful for reducing needle-based pain and distress. Our objective was to compare VR against standard care for children undergoing routine four-year-old immunisations. METHOD: This was a randomised controlled superiority trial conducted in a single suburban general practice, comparing a VR sequence of an interactive marine adventure to standard care (parental comfort, distraction of child). Our primary outcome was self-rated pain scores (Faces Pain Scale - Revised and the poker chip tool). Secondary outcomes included observational ratings (visual analogue scales) of pain and distress from caregivers and an observing healthcare provider, and overall enjoyment of the immunisation experience for the parent and child. RESULTS: In all, 42 children received VR and 45 received standard care. There was no difference in the primary outcome, with median interquartile range self-rated pain scores of 2 (0-8) in the standard care group and 2 (0-6) in the VR group. Observer ratings of pain and distress, as well as ratings of overall enjoyment, favoured VR. There were no significant adverse events. DISCUSSION: VR was not superior to standard care for self-rated pain and distress in children aged four years receiving routine immunisations. However, parent and observer ratings of pain and distress and overall ratings of enjoyment all favoured VR.

The VRIMM study: Virtual Reality for IMMunisation pain in young children-protocol for a randomised controlled trial.

INTRODUCTION: Pain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive 'virtual world', has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations. METHODS AND ANALYSIS: The study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects. ETHICS AND DISSEMINATION: Ethics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12618001363279.