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

ABSTRACT: 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.

SUBMITTER: Ellerton K

PROVIDER: S-EPMC7443262 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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

Ellerton Kirrily K Tharmarajah Harishan H Medres Rimma R Brown Lona L Ringelblum David D Vogel Kateena K Dolphin Amanda A McKellar Sue S Bridson Fiona F John-White Marietta M Craig Simon S

BMJ open 20200820 8

<h4>Introduction</h4>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 ...[more]

PMID: 32819997

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Project description:IntroductionIntravenous (IV) insertions are among the most performed procedures for children seeking medical care; they are often a painful and stressful experience for both children and their caregivers. Paediatric distress and pain that is inadequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for both the family and clinical team. We hypothesise that distraction via an immersive virtual reality (VR) experience may reduce the associated distress for children undergoing IV insertions.Methods and analysisThis two-armed randomised controlled superiority trial will be conducted in a Canadian paediatric emergency department and will aim to enrol 80 children overall. Children will be randomised to receive either departmental standard of care alone or standard of care plus an immersive VR experience. Children 6-17 years of age who are undergoing IV insertion and have topical anaesthetic application will be considered for inclusion. Our primary objective is to compare the reduction of distress between the two study arms. The primary outcome will be the child's observed distress score as measured by the Observational Signs of Behavioral Distress-Revised tool. Secondary outcomes include the child's pain intensity and fear, parental anxiety, satisfaction with the IV procedure, as well as adverse events. Recruitment launched in September 2020 and is expected to end in March 2022.Ethics and disseminationThis study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent will be obtained from parents or guardians, and assent from children. Study data will be submitted for publication irrespective of results. This study is funded through a Women and Children's Health Research Institute Innovation grant. Purchase of the VR equipment was facilitated through a Stollery Children's Hospital Foundation small equipment grant.Trial registration numberNCT04291404Cite Now.

Project description:IntroductionVirtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.Methods and analysisThis is a single centre, prospective, randomised, clinical trial. Ninety children/adolescents, aged 8-18 years, presenting for Nuss repair of pectus excavatum will be randomised to 1 of 3 study arms (VR-GR, VR-D and 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10 min. Patients randomised to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomised to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomised to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcome is pain intensity. Secondary outcomes include pain unpleasantness, anxiety and opioid and benzodiazepine consumption.Ethics and disseminationThis study follows Standard Protocol Items: Recommendations for Interventional Trials guidelines. The protocol was approved by the Cincinnati Children's Hospital Medical Center's institutional review board. Patient recruitment began in July 2020. Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04351776.

Project description:IntroductionThe annual mortality and national expense of the opioid crisis continue to rise in the USA (130 deaths/day, $50 billion/year). Opioid use disorder usually starts with the prescription of opioids for a medical condition. Its risk is associated with greater pain intensity and coping strategies characterised by pain catastrophising. Non-pharmacological analgesics in the hospital setting are critical to abate the opioid epidemic. One promising intervention is virtual reality (VR) therapy. It has performed well as a distraction tool and pain modifier during medical procedures; however, little is known about VR in the acute pain setting following traumatic injury. Furthermore, no studies have investigated VR in the setting of traumatic brain injury (TBI). This study aims to establish the safety and effect of VR therapy in the inpatient setting for acute traumatic injuries, including TBI.Methods and analysisIn this randomised within-subjects clinical study, immersive VR therapy will be compared with two controls in patients with traumatic injury, including TBI. Affective measures including pain catastrophising, trait anxiety and depression will be captured prior to beginning sessions. Before and after each session, we will capture pain intensity and unpleasantness, additional affective measures and physiological measures associated with pain response, such as heart rate and variability, pupillometry and respiratory rate. The primary outcome is the change in pain intensity of the VR session compared with controls.Ethics and disseminationDissemination of this protocol will allow researchers and funding bodies to stay abreast in their fields through exposure to research not otherwise widely publicised. Study protocols are compliant with federal regulation and University of Maryland Baltimore's Human Research Protections and Institutional Review Board (protocol number HP-00090603). Study results will be published on completion of enrolment and analysis, and deidentified data can be shared by request to the corresponding author.Trial registration numberNCT04356963; Pre-results.

Project description:We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child's pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian's satisfaction and rating of the child's distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child's refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0-3.0; vs. 3.3, IQR: 2.7-6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian's satisfaction and anxiety or his/her rating of the child's pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

Project description:IntroductionCurrent clinical applications of virtual reality (VR) provide patients with transient pain relief during acutely painful events by redirecting attention. Biofeedback (BF) is a mind-body therapy that effectively produces sustained pain reduction, but there are obstacles to its routine use. Combined, BF-based VR (VR-BF) may increase accessibility while enhancing the benefits of BF. VR-BF has yet to be employed in perioperative care, and as such, no defined treatment protocol for VR-BF exists. The primary aim of this study is to assess the feasibility of the perioperative use of VR-BF in children and adolescents. The secondary aims are to assess the acceptability of VR-BF and to collect pilot efficacy data.Methods and analysisThis is a single-centre, randomised controlled pilot clinical trial. A total of 70 patients (12-18 years) scheduled for surgery anticipated to cause moderate to severe pain with ≥1 night of hospital admission will be randomised to one of two study arms (VR-BF or control). Participants randomised to VR-BF (n=35) will use the ForeVR VR platform to engage their breathing in gamified VR applications. Participants randomised to control (n=35) will interact with a pain reflection app, Manage My Pain. The primary outcome is feasibility of VR-BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and adherence to the protocol. Secondary outcomes are acceptability of VR-BF and pilot efficacy measures, including pain, anxiety and opioid consumption.Ethics and disseminationThe protocol was approved by the Nationwide Children's Hospital Institutional Review Board (IRB #STUDY00002080). Patient recruitment begins in March 2023. Written informed consent is obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Data will be available per request and results will be posted on ClinicalTrials.gov.Trial registration numberClinicalTrials.gov Registry (NCT04943874).

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

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

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