Lambert Veronica, Boylan Patrick, Boran Lorraine, Hicks Paula, Kirubakaran Richard, Devane Declan, Matthews Anne
School of Nursing, Psychotherapy and Community Health, Dublin City University, Dublin, Ireland.
School of Psychology, Dublin City University, Dublin, Ireland.
Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD010686. doi: 10.1002/14651858.CD010686.pub2.
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.
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.
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.
Randomised controlled trials (RCTs), including cross-over and cluster-RCTs, comparing VR distraction to no distraction, non-VR distraction or other VR distraction.
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.
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.
虚拟现实（VR）计算机技术创造了一个模拟环境，被认为可与现实世界相媲美，用户能够与之进行积极互动。VR分散注意力对儿童急性疼痛强度的有效性尚不确定。
评估在任何医疗环境中，虚拟现实（VR）分散注意力干预措施对患有急性疼痛的儿童（0至18岁）的有效性和不良反应。
我们检索了截至2019年10月的Cochrane系统评价数据库、医学期刊数据库（MEDLINE）、荷兰医学文摘数据库（Embase）、护理学与健康领域数据库（CINAHL）、心理学文摘数据库（PsycINFO）以及四个试验注册库。我们还检索了符合条件的研究的参考文献列表，手工检索了相关期刊，并联系了研究作者。
随机对照试验（RCT），包括交叉试验和整群随机对照试验，比较VR分散注意力与无分散注意力、非VR分散注意力或其他VR分散注意力。
我们采用了标准的Cochrane方法学流程。两名评价员独立评估偏倚风险并提取数据。主要结局是急性疼痛强度（在操作过程中以及操作后长达一小时）。次要结局包括不良反应、儿童对VR的满意度、与疼痛相关的痛苦、家长焦虑、急救镇痛和成本。我们使用了GRADE方法并创建了“结果总结”表。
我们纳入了17项RCT（1008名年龄在4至18岁之间的参与者），他们在医疗环境中接受各种操作。我们未进行数据合并，因为人群的异质性（即儿童的不同年龄和发育阶段以及他们对疼痛的不同认知和反应）以及操作条件的差异（例如静脉穿刺、烧伤伤口换药、物理治疗课程），以及由此产生的疼痛程度差异，使得数据的统计合并变得不可能。我们对结果进行了叙述性描述。我们判断大多数研究在选择偏倚风险方面不明确，在实施和检测偏倚方面风险较高，且由于样本量小而存在较高的偏倚风险。在所有比较和结局中，由于严重的研究局限性和严重或非常严重的间接性，我们将证据的确定性降级为低或极低。我们还因非常严重的不精确性对部分证据进行了降级。1：VR分散注意力与无分散注意力 急性疼痛强度：操作过程中 自我报告：一项研究（42名参与者）发现非沉浸式VR无有益效果（证据确定性极低）。观察者报告：无数据。行为测量（观察者报告）：两项研究，62名参与者；证据确定性低。一项研究（n = 42）发现非沉浸式VR无有益效果。一项研究（n = 20）发现沉浸式VR有有益效果。急性疼痛强度：操作后 自我报告：10项研究，461名参与者；证据确定性极低。四项研究（n = 95）发现沉浸式、半沉浸式或非沉浸式VR无有益效果。五项研究（n = 357）发现沉浸式VR有有益效果。另一项研究（n = 9）报告VR组疼痛较轻。观察者报告：两项研究（216名参与者；证据确定性低）发现主要照顾者/家长或护士报告沉浸式VR有有益效果。一项研究（n = 80）发现研究人员报告沉浸式VR有有益效果。行为测量（观察者报告）：一项研究（42名参与者）发现非沉浸式VR无有益效果（证据确定性极低）。不良反应：五项研究，154名参与者；证据确定性极低。三项研究（n = 53）报告无不良反应。两项研究（n = 101）报告VR组有轻微不良反应（如恶心）。2：VR分散注意力与其他非VR分散注意力 急性疼痛强度：操作过程中 自我报告、观察者报告和行为测量（观察者报告）：两项研究，106名参与者：自我报告：一项研究（n = 65）发现沉浸式VR有有益效果，一项（n = 41）发现平均疼痛变化评分无差异证据（证据确定性极低）。观察者报告：一项研究（n = 65）发现沉浸式VR有有益效果，一项（n = 41）发现平均疼痛变化评分无差异证据（证据确定性低）。行为测量（观察者报告）：一项研究（n = 65）发现沉浸式VR有有益效果，一项（n = 41）报告VR组平均疼痛变化评分有差异且疼痛行为较少（证据确定性低）。急性疼痛强度：操作后 自我报告：八项研究，575名参与者；证据确定性极低。两项研究（n = 146）发现沉浸式VR有有益效果。两项研究（n = 252）报告组间差异有利于沉浸式VR。一项研究（n = 59）发现沉浸式VR与电视和儿童生活非VR分散注意力相比无有益效果。一项研究（n = 18）发现半沉浸式VR无有益效果。两项研究（n = 100）报告组间无差异。观察者报告：三项研究，187名参与者；证据确定性低。一项研究（n = 81）发现家长、护士和研究人员报告沉浸式VR有有益效果。一项研究（n = 65）发现照顾者报告沉浸式VR有有益效果。另一项研究（n = 41）报告平均疼痛变化评分无差异证据。行为测量（观察者报告）：两项研究，106名参与者；证据确定性低。一项研究（n = 65）发现沉浸式VR有有益效果。另一项研究（n = 41）报告平均疼痛变化评分无差异证据。不良反应：六项研究，429名参与者；证据确定性极低。三项研究（n = 229）发现组间无差异证据。两项研究（n = 141）报告VR组无不良反应。一项研究（n = 59）报告VR沉浸前后估计的网络病无有益效果。3：VR分散注意力与其他VR分散注意力 我们未找到此比较的任何研究。
我们发现，与无分散注意力或其他非VR分散注意力相比，VR分散注意力在降低任何医疗环境中儿童急性疼痛强度方面的有效性证据确定性低或极低。这种不确定性水平使得难以解释VR分散注意力对儿童急性疼痛的益处或缺乏益处。本综述的大多数主要结局仅由两三项小型研究评估。我们发现不良反应和其他次要结局的数据有限。未来设计良好、大规模、高质量的试验可能会对我们对结果的信心产生重要影响。
