Background
Virtual reality (VR) is a computer technology that creates a simulated environment, which users perceive as comparable to the real world. VR draws the user’s attention to a virtual environment using real-time computer graphics and may modulate children's pain when undergoing healthcare treatments. Uncertainty exists over the effectiveness of VR distraction on pain in children.
Objectives
To assess the effectiveness and adverse effects of virtual reality (VR) distraction interventions for children (0 - 18 years) with acute pain in any healthcare setting.
Search methods
We searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO and four trial registries up to October 2019 together with reference checking, relevant journal searches and contact with study authors to identify additional studies.
Selection criteria
Randomised controlled trials (RCTs), including cross-over and cluster RCTs, comparing VR distraction to no distraction, other non-VR distraction or other VR distraction.
Data collection and analysis
We used standard Cochrane methodological processes. Two reviewers assessed risk of bias and extracted data independently. The primary outcome was acute pain intensity, measured using self-report, observer-report and behavioural measurements, assessed during and post procedure. Secondary outcomes were adverse effects, child satisfaction with VR, pain-related distress, parent anxiety, rescue analgesia and cost. We used GRADE to assess certainty of the evidence and created 'Summary of findings' tables.
Main results
We included 18 RCTs with 1023 participants (aged 4 - 18 years) undergoing procedures for intravenous puncture or port access, wound dressing changes, physical therapy and treatment for vaso-occlusive crisis. Studies were not suitable for pooling because of heterogeneity in population and procedural conditions. We report mean difference (MD) and narratively describe results. We judged most studies as unclear risk of selection bias and high risk of performance and detection bias. We downgraded certainty of evidence due to serious study limitations (risk of bias), inconsistency in effect estimates, and imprecision.
Comparison 1: VR distraction compared to no distraction
1. Acute pain intensity - during procedure
a. Self-report
No beneficial effect of non-immersive VR (MD 0.56, 95% CI -0.95 to 2.07; one study, 42 participants; low certainty evidence).
b. Observer-report
No data.
c. Behavioural measurements (observer-report)
Three studies reported this (77 participants; very low certainty evidence). One study found no beneficial effect of non-immersive VR (MD -0.57, 95% CI -1.66 to 0.52). Another study found a beneficial effect favouring immersive VR (MD -3.40, 95% CI -5.01 to -1.79). One study reported that the average pain score was lower for immersive VR.
2. Acute pain intensity - post procedure (up to one hour)
a. Self-report
Eleven studies reported this (474 participants; very low certainty evidence). Four studies found no beneficial effect of immersive (MD -1.60, 95% CI -3.24 to 0.04) and (MD -0.60, 95% CI -2.47 to 1.27), semi-immersive (MD 21.20, 95% CI -8.31 to 50.71) or non-immersive (MD 0.54, 95% CI -0.32 to 1.40) VR. Another study reported no difference in average observed pain score for immersive VR. Five studies found a beneficial effect favouring immersive VR (MD -1.00, 95% CI -1.90 to -0.10) and (MD -3.60, 95% CI -3.74 to -3.46) and (MD -3.42, 95% CI -4.47 to -2.37) and (MD -2.90, 95% CI -3.57 to -2.23) and (MD -14.33, 95% CI -25.42 to -3.24). Another study of 11 trials undertaken from 7 children, reported less pain in the VR group.
b. Observer-report
Two studies reported this (216 participants; low certainty evidence). Both studies found a beneficial effect of immersive VR for primary caregiver/parent (MD -1.03, 95% CI -1.88 to -0.18) and (MD -3.20, 95% CI -3.34 to -3.06) and nurse (MD -1.00, 95% CI -1.77 to -0.23) and (MD -2.70, 95% CI -2.81 to -2.59) reports. One study found a beneficial effect of immersive VR for researcher reports (MD -4.10, 95% CI -4.24 to -3.96).
c. Behavioural measurements (observer-report)
Two studies reported this (57 participants; very low certainty evidence). One study found no beneficial effect of non-immersive VR (MD 0.10, 95% CI -0.22 to 0.42). One study reported no difference in average pain score for immersive VR.
Adverse effects
Five studies reported this (154 participants; very low certainty evidence). Three studies reported no adverse effects. Two studies reported mild adverse effects in the VR group.
Comparison 2: VR distraction compared to other non-VR distraction
1. Acute pain intensity - during the procedure
a. Self-report
Two studies reported this (106 participants; very low certainty evidence). One study found a beneficial effect favouring immersive VR (MD -1.77, 95% CI -2.74 to -0.80). Another study found no difference in mean pain change scores.
b. Observer-report
Two studies reported this (106 participants; very low certainty evidence). One study found a beneficial effect favouring immersive VR (MD -1.90, 95% CI -3.23 to -0.57). Another study found no difference in mean pain change scores.
c. Behavioural measurements (observer-report)
Two studies reported this (106 participants; low certainty evidence). One study found a beneficial effect favouring immersive VR (MD -3.18, 95% CI -4.75 to -1.61). Another study reported a difference in mean pain change scores with fewer pain behaviours observed for the VR group.
2. Acute pain intensity - post procedure (up to one hour)
a. Self-report
Eight studies reported this (575 participants; very low certainty evidence). Two studies found a beneficial effect favouring immersive VR (MD -0.90, 95% CI -1.70 to -0.10) and (MD -0.50, 95% CI -0.59 to -0.41). Two other studies reported a between group difference favouring immersive VR. One study found no beneficial effect of immersive VR compared with TV (MD -13.68, 95% CI -29.64 to 2.28) and Child Life (MD -3.58, 95% CI -19.31 to 12.15) non-VR distraction. One study found no beneficial effect of semi-immersive VR (MD 28.00, 95% CI -0.46 to 56.46). Two studies reported no between group difference.
b. Observer-report
Three studies reported this (187 participants; very low certainty evidence). One study found a beneficial effect favouring immersive VR for parent (MD -0.50, 95% CI -0.59 to -0.41), nurse (MD -0.20, 95% CI -0.27 to -0.13) and researcher (MD -0.50, 95% CI -0.59 to -0.41) reports. One study found a beneficial effect favouring immersive VR for caregiver reports (MD -3.27, 95% CI -4.12 to -2.42). Another study reported no difference in mean pain change scores.
c. Behavioural measurements (observer-report)
Two studies reported this (106 participants; very low certainty evidence). One study found a beneficial effect favouring immersive VR (MD -2.11, 95% CI -3.73 to -0.49). Another study reported no difference in mean pain change scores.
Adverse effects
Six studies reported this (429 participants; low certainty evidence). Three studies found no difference between groups for adverse effects. Two studies reported no adverse effects in the VR group. One study reported that the change in estimated cyber sickness before and after VR immersion was not significant.
Comparison 3: VR distraction compared to other VR distraction
We found no studies for this comparison.
Authors' conclusions
We found low and very low certainty evidence of the effectiveness of VR distraction compared to no distraction or other non-VR distraction in reducing acute pain intensity in children in any healthcare setting. Most of the review primary outcomes were assessed by only two or three studies with small sample sizes. We found limited data for adverse effects related to VR and other secondary outcomes and therefore can draw no conclusions. Future large high quality trials are likely to have an important impact on our confidence in the estimate of effect.