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 strategie...

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Main Authors: Simon Craig, Kirrily Ellerton, Harishan Tharmarajah, Rimma Medres, Lona Brown, David Ringelblum, Kateena Vogel, Amanda Dolphin, Sue McKellar, Fiona Bridson, Marietta John-White
Format: Article
Language:English
Published: BMJ Publishing Group 2020-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/8/e038354.full
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author Simon Craig
Kirrily Ellerton
Harishan Tharmarajah
Rimma Medres
Lona Brown
David Ringelblum
Kateena Vogel
Amanda Dolphin
Sue McKellar
Fiona Bridson
Marietta John-White
author_facet Simon Craig
Kirrily Ellerton
Harishan Tharmarajah
Rimma Medres
Lona Brown
David Ringelblum
Kateena Vogel
Amanda Dolphin
Sue McKellar
Fiona Bridson
Marietta John-White
author_sort Simon Craig
collection DOAJ
description 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.
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spelling doaj-art-2ca7b4e9227548eba50ff54205a0ddfd2025-08-20T02:49:17ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-038354The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trialSimon Craig0Kirrily Ellerton1Harishan Tharmarajah2Rimma Medres3Lona Brown4David Ringelblum5Kateena Vogel6Amanda Dolphin7Sue McKellar8Fiona Bridson9Marietta John-White102 Department of Paediatrics, Monash University, Clayton, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaWellness on Wellington General Practice, Rowville, Victoria, AustraliaEmergency Department, Monash Medical Centre Clayton, Clayton, Victoria, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/10/8/e038354.full
spellingShingle Simon Craig
Kirrily Ellerton
Harishan Tharmarajah
Rimma Medres
Lona Brown
David Ringelblum
Kateena Vogel
Amanda Dolphin
Sue McKellar
Fiona Bridson
Marietta John-White
The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
BMJ Open
title The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
title_full The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
title_fullStr The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
title_full_unstemmed The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
title_short The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial
title_sort vrimm study virtual reality for immunisation pain in young children protocol for a randomised controlled trial
url https://bmjopen.bmj.com/content/10/8/e038354.full
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