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

Ellerton, Kirrily; Tharmarajah, Harishan; Medres, Rimma; Brown, Lona; Ringelblum, David; Vogel, Kateena; Dolphin, Amanda; McKellar, S.; Bridson, Fiona; John-White, Marietta; Craig, Simon

doi:10.1136/bmjopen-2020-038354

Cited by 12 publications

(14 citation statements)

References 18 publications

(27 reference statements)

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“…However the effect of VR in pediatric procedures were mainly observed in dental procedures and other inpatient needle-related procedures such as venipuncture, IV cannulation and port access (15,18,19). The evidence for VR usage in immunization, is limited (21)(22)(23).This present study has shown the feasibility of using VR in childhood immunization, with potential effectiveness in alleviating the pain and anxiety in immunization among children. A future RCT with customized VR design incorporating multiple stakeholders perspective is required to examine the effectiveness of VR in reducing pain and anxiety during immunization among children (24).…”

Section: Discussionmentioning

confidence: 63%

“…A recent systematic review and meta-analysis concluded that VR mitigates procedural pain and anxiety in pediatrics, but it also reported high risk of bias across studies and significant publication bias (18). Currently, robust evidence on the effectiveness of VR to alleviate pain and anxiety during childhood immunization is limited (21)(22)(23). While Rudnick Chad et al, had shown pain and fear alleviation in children wearing a VR headset, it was a feasibility study with a single arm (21).…”

Section: Introductionmentioning

confidence: 99%

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Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial

et al. 2022

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BackgroundPediatric immunization is often associated with significant fear and anxiety among the children and their parents. Their distress may potentially affect their adherence to the childhood immunization schedule and the acceptance of other recommended vaccines by physicians.ObjectiveThe study primarily aimed to assess the feasibility of using immersive virtual reality (VR) during immunization in children in primary care. The secondary aim was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children, reduction of anxiety of their parents and attending nurses during immunization compared to usual care without VR.MethodsA pilot open-label randomized control trial was conducted at a public primary care clinic in Singapore. Thirty children, aged 4–10 years were randomized to an intervention group (n = 15) using VR and a control group (n = 15) without VR during immunization. Feasibility was assessed by the response rate to the use of VR. The Faces Pain Scale-Revised (FPS-R) and the Children’s Fear Scale (CFS) were used to determine their pain and anxiety, respectively. The anxiety level of their accompanying parents and attending nurses were evaluated using Visual Analog Scale (VAS) prior and post-immunization of these children. The FPS-R and CFS scores, and anxiety assessment for parents and nurses were assessed using Mann-Whitney U test. Wilcoxon signed rank test was used to assess the difference in the nurses’ experience of using the VR application.ResultsOne child refused to use the VR equipment, constituting a rejection rate of 6.7% (1/15) but no adverse event occurred in the intervention arm. The overall response rate of 88% (30/34) when the parents were approached to participate in the study, indicating feasibility of using VR in childhood immunization. In the intervention group compared to the control group, the change in scores for CFS (median −1, IQR −2 to 0; P = 0.04), parental VAS (median −4, IQR −5 to −1; P = 0.04) were significantly decreased. After immunization, nurses scored favorably for VR, in terms of simplicity (median 9.5, IQR 5.72 to 10; P = 0.01), acceptability (median 10, IQR 5 to 10; P = 0.005) and willingness to use VR in the future (median 10, IQR 5 to 10; P = 0.02).ConclusionImmersive VR is feasible, safe and effective in alleviating anxiety among the children and parents. Nurses viewed the application of VR in childhood immunization favorably.Clinical Trial Registration[https://clinicaltrials.gov/ct2/show/NCT04748367], identifier [NCT04748367].

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Section: Discussionmentioning

confidence: 63%

Section: Introductionmentioning

confidence: 99%

Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial

et al. 2022

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“…Among other possible explanations, perhaps this lack of research can be explained by health care staff overload or low levels of motivation among professionals or toward the support of research [63][64][65][66][67]. However, 2 study protocols have recently been published that will aim to evaluate the effectiveness of VR against pain during vaccination in the pediatric population through RCTs with estimated sample sizes of 100 [68] to more than 400 participants [69].…”

Section: Discussionmentioning

confidence: 99%

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis

Lluesma-Vidal¹,

González²,

García-Garcés³

et al. 2022

JMIR Serious Games

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Background Virtual reality (VR) is used as a distraction measure during painful clinical procedures associated with the use of needles. These procedures include vaccinations, blood draws, or the administration of medications, which can cause children to feel increased levels of pain and fear. Objective The objective of this study was to collect and analyze the current evidence regarding the effectiveness of VR as a tool to distract children from pain and fear during needle procedures as compared to that of standard techniques. Methods A systematic review and meta-analysis was performed. We included randomized clinical trials (RCTs) or quasi-RCTs with participants younger than 21 years who underwent needle procedures in which the main distraction measure used was VR and where the main outcome measure was pain. The databases searched included the PubMed, Web of Science, Scopus, PsycINFO, CINAHL, and Cochrane libraries. In this systematic review, the studies were analyzed by applying the Critical Appraisal Skills Program guide in Spanish and the Jadad scale. In the meta-analysis, the effect size of the studies was analyzed based on the results for pain and fear in children. Results From 665 unique search results, 21 studies were included in this systematic review, most of which reported low methodological quality. The study sample cohorts ranged from a minimum of 15 participants to a maximum of 220 participants. Ten studies were included in the meta-analysis. The global effect of using VR as a distraction measure was a significant reduction in pain (inverse variance [IV] –2.37, 95% CI –3.20 to –1.54; Z=5.58; P<.001) and fear (IV –1.26, 95% CI –1.89 to –0.63; Z=3.92; P<.001) in children in the experimental groups. Conclusions The quality of the studies was mostly low. The main limitations were the impossibility of blinding the participants and health care personnel to the VR intervention. Nonetheless, the use of VR as a distraction measure was effective in reducing pain and fear in children during procedures involving needles.

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“…Further studies have proven the feasibility of VR for converting unpleasant emotional experiences into less distressing, potentially pain-free events among children 5 who are exposed to needle procedures such as peripheral intravenous (IV), 13 lumbar punctures or blood draws, 14–17 and vaccinations. 8 , 18 …”

Section: Introductionmentioning

confidence: 99%

“…5,8,[10][11][12][13][14][15][16][22][23][24][25][26][27][28] Further studies have proven the feasibility of VR for converting unpleasant emotional experiences into less distressing, potentially pain-free events among children 5 who are exposed to needle procedures such as peripheral intravenous (IV), 13 lumbar punctures or blood draws, [14][15][16][17] and vaccinations. 8,18 In Saudi Arabia, the Ministry of Health (MOH) has launched a Virtual Reality (VR) intervention program in selected Primary Care Centers (PHCs) around the country, as an initiative to decrease needle phobia and improve children's experience in routine vaccinations. 7 It has been reported that up to 10% of the population avoid vaccination due to needle phobia.…”

Section: Introductionmentioning

confidence: 99%

Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination?

Althumairi¹,

Sahwan²,

Alsaleh³

et al. 2021

JMDH

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Background Virtual reality (VR) is an innovative distraction technology in health care, but little is known about this topic in Saudi Arabia. The aim of this study was to assess the effectiveness of using VR to reduce pain and fear among children during vaccination. Methods It is a cross-sectional study design. A total of 104 children (ages 4–6 years) receiving routine vaccinations in a single primary health care in Eastern Region, Saudi Arabia, participated in the study and grouped to a VR technology intervention group or vaccination as usual without VR distraction. The primary outcome is the difference in the child’s self-rated fear and pain scores between those who have been vaccinated with or without VR distraction, measured by the two validated international facial expressions scales Wong–Baker FACES Pain Scale and Children’s Fear Scale. Results In the two-month study period, 53 children were vaccinated using the VR technology and 50 children were vaccinated without VR. Bivariate analysis showed a significantly lower pain score among the VR group ( =1.36, SD 2.06) compared with the group without VR ( =6.90, SD 3.47) (P-value < 0.001). Similarly, fear score was lower in the VR group ( =0.64, SD 0.92) compared with the group without VR ( =2.88, SD1.55) (P < 0.001). In multivariable regression models adjusted for age and gender, children vaccinated using the VR technology had significantly lower pain and fear scores compared with those who were vaccinated as usual without VR distraction. Conclusion VR technology showed a positive impact on reducing pain and fear among children aged 4–6 years during vaccination. Policymakers are encouraged to expand the use of this distraction tool in primary health centers to improve the vaccination experience among children.

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

Cited by 12 publications

References 18 publications

Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial

Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis

Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination?

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