Abstract

Background

Virtual reality (VR) computer technology creates a simulated environment, perceived as comparable to the real world, with which users can actively interact. The effectiveness of VR distraction on acute pain intensity in children is uncertain.

Objectives

To assess the effectiveness and adverse effects of virtual reality (VR) distraction interventions for children (0 to 18 years) with acute pain in any healthcare setting.

Search methods

We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and four trial registries to October 2019. We also searched reference lists of eligible studies, handsearched relevant journals and contacted study authors.

Selection criteria

Randomised controlled trials (RCTs), including cross‐over and cluster‐RCTs, comparing VR distraction to no distraction, 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 (during procedure, and up to one hour post‐procedure). Secondary outcomes were adverse effects, child satisfaction with VR, pain‐related distress, parent anxiety, rescue analgesia and cost. We used GRADE and created 'Summary of findings' tables.

Main results

We included 17 RCTs (1008 participants aged four to 18 years) undergoing various procedures in healthcare settings. We did not pool data because the heterogeneity in population (i.e. diverse ages and developmental stages of children and their different perceptions and reactions to pain) and variations in procedural conditions (e.g. phlebotomy, burn wound dressings, physical therapy sessions), and consequent level of pain experienced, made statistical pooling of data impossible. We narratively describe results.

We judged most studies to be at unclear risk of selection bias, high risk of performance and detection bias, and high risk of bias for small sample sizes. Across all comparisons and outcomes, we downgraded the certainty of evidence to low or very low due to serious study limitations and serious or very serious indirectness. We also downgraded some of the evidence for very serious imprecision.

1: VR distraction versus no distraction

Acute pain intensity: during procedure

Self‐report: one study (42 participants) found no beneficial effect of non‐immersive VR (very low‐certainty evidence).

Observer‐report: no data.

Behavioural measurements (observer‐report): two studies, 62 participants; low‐certainty evidence. One study (n = 42) found no beneficial effect of non‐immersive VR. One study (n = 20) found a beneficial effect favouring immersive VR.

Acute pain intensity: post‐procedure

Self‐report: 10 studies, 461 participants; very low‐certainty evidence. Four studies (n = 95) found no beneficial effect of immersive and semi‐immersive or non‐immersive VR. Five studies (n = 357) found a beneficial effect favouring immersive VR. Another study (n = 9) reported less pain in the VR group.

Observer‐report: two studies (216 participants; low‐certainty evidence) found a beneficial effect of immersive VR, as reported by primary caregiver/parents or nurses. One study (n = 80) found a beneficial effect of immersive VR, as reported by researchers.

Behavioural measurements (observer‐report): one study (42 participants) found no beneficial effect of non‐immersive VR (very low‐certainty evidence).

Adverse effects: five studies, 154 participants; very low‐certainty evidence. Three studies (n = 53) reported no adverse effects. Two studies (n = 101) reported mild adverse effects (e.g. nausea) in the VR group.

2: VR distraction versus other non‐VR distraction

Acute pain intensity:during procedure

Self‐report, observer‐report and behavioural measurements (observer‐report): two studies, 106 participants:

Self‐report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (very low‐certainty evidence).

Observer‐report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (low‐certainty evidence).

Behavioural measurements (observer‐report): one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) reported a difference in mean pain change scores with fewer pain behaviours in VR group (low‐certainty evidence).

Acute pain intensity: post‐procedure

Self‐report: eight studies, 575 participants; very low‐certainty evidence. Two studies (n = 146) found a beneficial effect favouring immersive VR. Two studies (n = 252) reported a between‐group difference favouring immersive VR. One study (n = 59) found no beneficial effect of immersive VR versus television and Child Life non‐VR distraction. One study (n = 18) found no beneficial effect of semi‐immersive VR. Two studies (n = 100) reported no between‐group difference.

Observer‐report: three studies, 187 participants; low‐certainty evidence. One study (n = 81) found a beneficial effect favouring immersive VR for parent, nurse and researcher reports. One study (n = 65) found a beneficial effect favouring immersive VR for caregiver reports. Another study (n = 41) reported no evidence of a difference in mean pain change scores.

Behavioural measurements (observer‐report): two studies, 106 participants; low‐certainty evidence. One study (n = 65) found a beneficial effect favouring immersive VR. Another study (n = 41) reported no evidence of a difference in mean pain change scores.

Adverse effects: six studies, 429 participants; very low‐certainty evidence. Three studies (n = 229) found no evidence of a difference between groups. Two studies (n = 141) reported no adverse effects in VR group. One study (n = 59) reported no beneficial effect in reducing estimated cyber‐sickness before and after VR immersion.

3: VR distraction versus other VR distraction

We did not identify any studies for this comparison.

Authors' conclusions

We found low‐certainty 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. This level of uncertainty makes it difficult to interpret the benefits or lack of benefits of VR distraction for acute pain in children. Most of the review primary outcomes were assessed by only two or three small studies. We found limited data for adverse effects and other secondary outcomes. Future well‐designed, large, high‐quality trials may have an important impact on our confidence in the results.

Author(s)

Veronica Lambert, Patrick Boylan, Lorraine Boran, Paula Hicks, Richard Kirubakaran, Declan Devane, Anne Matthews

Abstract

Plain language summary

What are the benefits and risks of using virtual reality in a healthcare setting to distract children from pain?

Why is this question important?

Medical procedures, such as health examinations or injections, can cause children to experience pain. In these situations, it is common practice to distract children using toys or play, in order to minimise distress and fear of pain.

One form of distraction that can be used is virtual reality. Virtual reality is an artificial environment with scenes and objects that appear to be real (for example a frozen world, or a wildlife park). Virtual reality can be:

‐ Fully‐immersive: users typically wear a headset with headphones and a screen, and interact with the virtual environment as if they were really in it.

‐ Semi‐immersive: users interact with a partially virtual environment (for example, a flight simulator where the controls are real, but the windows display virtual images).

‐ Non‐immersive: the user is connected to the virtual world by a separate monitor (for example, a computer) but can still experience the real world.

To find out whether virtual reality can distract children from pain, and whether it is associated with any adverse (unwanted) effects, we reviewed the research evidence.

How did we identify and evaluate the evidence?

We searched the medical literature for randomised controlled studies (clinical studies where people are randomly put into one of two or more treatment groups), because these provide the most robust evidence about the effects of a treatment. We compared and summarized their results. Finally, we rated our confidence in the evidence, based on factors such as study methods and sizes, and the consistency of findings across studies.

What did we find?

We found 17 studies that involved a total of 1008 children aged from four to 18 years. Medical procedures included injections, taking blood, changing wound dressings, and physical exercise. Studies compared virtual reality against no distraction, or against non‐virtual distraction. No studies compared different types of virtual reality.

During a medical procedure

We cannot tell whether virtual reality reduces self‐reported pain during a medical procedure because we have too little confidence in the evidence available (three studies).

Only two studies investigated changes in pain assessed by an observer (for example, using a rating scale that ranges from 0 (no pain) to 10 (great pain)). These reported conflicting findings: in one study fully‐immersive virtual reality was beneficial compared to non‐virtual distraction, but not in the other.

Fully‐immersive virtual reality may reduce pain assessed by an observer based on children's behaviour (for example, crying, or rubbing a body part in a way that indicates pain) more effectively than non‐virtual distraction (two studies) or no distraction (one study).

Non‐immersive virtual reality was not beneficial for pain assessed by an observer based on children's behaviour compared to no distraction (one study).

After a medical procedure

We cannot tell whether virtual reality can reduce self‐reported pain after a medical procedure, as we have too little confidence in the evidence available (16 studies).

Five studies investigated changes in pain assessed by an observer. Virtual reality was beneficial compared to no distraction in two studies, and also when compared to non‐virtual distraction in another two studies. However, it was no better than non‐virtual distraction in one study.

Two studies investigating pain assessed by an observer based on children's behaviour reported conflicting findings: immersive virtual reality was beneficial compared to non‐virtual distraction in one study, but not in the other.

We cannot tell whether there is a difference between virtual reality and no distraction for pain assessed by an observer based on children's behaviour, as we have too little confidence in the available evidence (one study).

Adverse effects

We cannot tell if virtual reality is associated with adverse effects because we have too little confidence in the evidence available (11 studies).

What does this mean?

We have little to very little confidence in the evidence we identified. It is unclear from our review whether virtual reality distraction makes a difference to pain in children. There is a need for large, well‐designed studies in this area.

How up‐to date is this review?

The evidence in this Cochrane Review is current to October 2019.

Author(s)

Veronica Lambert, Patrick Boylan, Lorraine Boran, Paula Hicks, Richard Kirubakaran, Declan Devane, Anne Matthews

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

For children with acute pain

There is very little evidence for the use of VR technology in reducing pain in children. We found low‐ to very low‐certainty evidence of the benefit of VR distraction compared to no distraction or non‐VR distraction for the reduction of acute pain intensity in children (0‐18 years) undergoing clinical treatments and procedures. We found limited data to draw any conclusions about secondary outcomes including VR side‐effects, satisfaction with VR, pain‐related distress and administration of rescue analgesia. No studies assessed parent anxiety or cost. We have very little confidence in the evidence. Future well‐designed large high‐quality trials are likely to have an important impact on our confidence in the results.

For clinicians

There is very little evidence for the use of VR technology in reducing pain in children. We found low‐ to very low‐certainty evidence of the effectiveness of VR distraction interventions in reducing acute pain intensity in children to facilitate clinicians making informed evidence based decisions regarding treatment. We found limited data for adverse effects related to VR and other secondary outcomes including child satisfaction with VR, child pain‐related distress and rescue analgesia, therefore, we can draw no conclusions. No studies assessed parent anxiety or cost. We do not have any estimates on cost for these VR distraction interventions yet. More evidence is needed before VR distraction could be considered a potential treatment for consistently reducing acute pain intensity in children.

For policy makers and funders of the intervention

There is very little evidence for the use of VR technology in reducing pain and distress. The results of this review highlight that there is low‐ to very low‐certainty evidence of the benefit of VR distraction interventions for children with acute pain undergoing clinical procedures in healthcare settings. We found limited data for adverse effects related to VR, child satisfaction with VR, child pain related‐distress and administration of rescue analgesia. Parent anxiety was not assessed in any studies and we found no evidence on the cost or cost‐effectiveness of VR distraction interventions. There is insufficient evidence to recommend or refute the use of VR distraction interventions and more funding is needed to establish the evidence base in this area. Prioritising research calls in the area of children’s pain will be critical to leveraging funding to enable large consortiums of researchers, VR developers, industry/SMEs, health care providers, and care recipients (i.e. children and their family) to conduct large high‐quality clinical trials in the future to establish an evidence base for VR distraction for acute pain in children.

Implications for research 

General implications

We conclude, based on the 17 studies included in this review, that there is low‐ to very low‐certainty evidence for the use of VR distraction interventions for children with acute pain undergoing clinical procedures. Larger high‐quality studies to confirm the effectiveness and adverse effects of VR distraction interventions for children with acute pain in any healthcare setting are needed. While the 30 ongoing studies may contribute to future updates of this review, it is important that future trials use standardized age groups, such as those recommended by the US National Institute of Child Health and Human Development, to enhance consistency in reporting age‐related data for paediatric trials (Williams 2012). This would improve the potential for data synthesis, enable exploration of age group variation and similarity regarding treatment response and safety and enable recommendations to be tailored to specific age groups (Williams 2012). This is important in identifying which actual intervention is most effective for whom recognising that age and developmental stage may influence how pain and VR is experienced (Kortesluoma 2006; Won 2017). Another avenue for future research is to see if VR is beneficial for children with chronic pain. Chronic pain is different from acute pain and consequently the function of distraction in these contexts may also differ (i.e. adaptive in acute procedural pain versus potentially maladaptive in chronic pain) (Becker 2018).

Design

Large (i.e. at least 200 participants per arm) high‐quality randomised controlled trials, with cost‐effectiveness analyses, are needed to determine the effectiveness and adverse effects of VR distraction interventions for children with acute pain. Future research should compare VR with other types of widely accessible technological distractions (i.e. smart phones, iPads, tablets, apps); other types of reality such as augmented reality (i.e. virtual experience created by superimposing a virtual image within the real environment) and other types of VR using different VR environments (e.g. off‐the‐shelf pre‐existing virtual content versus customised content created for specific clinical purposes/procedures). Future research should give greater attention to children’s preference regarding distraction and whether child characteristics such as temperament have an important influence on the effectiveness of the distraction stimulus (Koller 2012; MacLaren 2007). Future trials also need to establish the effectiveness of VR across a variety of clinical experiences with different pain intensities and distress‐levels experienced by children, including for example, pain caused by diagnosed illness and associated treatments (e.g. renal or urinary diseases and inflammatory conditions); pain caused by medical and diagnostic procedures and fundamental nursing (e.g. post‐operative treatment, bone marrow procedures and spinal cord injections, side‐effects of medications); and pain caused by accidents (e.g. resetting of fractures or dislocation, suturing and removal of stitches) (Kortesluoma 2004; Kortesluoma 2006). Also specific to future cross‐over trials, investigators should use the Consolidated Standards of Reporting Trials (CONSORT) statement extended to crossover trials to improve reporting of randomised crossover trials; thereby assisting researchers in extracting data for systematic reviews and in judging the reliability and validity of trial findings (Dwan 2019).

Measurement (endpoints)

Future large high‐quality trials using a standardized approach to measuring and reporting similar outcomes across studies are likely to have an influence on the ability to compare and pool data. A specific implication of this review is the need for future trial investigators to use core outcome domains for paediatric acute pain clinical trials such as those developed by McGrath 2008 (i.e. pain intensity, global judgement of satisfaction with treatment, symptoms and adverse effects, physical recovery, emotional response and economic factors); in addition to using recommended validated pain outcome measures (self‐report and observational) that take account of children's different developmental abilities across different age groups (Stinson 2006; von Baeyer 2007).

Also, specific to future VR trials, investigators should consider other mechanisms advanced in VR effectiveness for children with acute pain including the assessment of immersion and presence of the child in the VR environment (Won 2017). For example, the ITC‐Sense of Presence Inventory offers researchers using a range of media systems a tool to measure, post exposure, four facets of a media experience related to presence; including sense of physical space, engagement, ecological validity and negative effects (Lessister 2001).

Get full text at The Cochrane Library