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虚拟现实用于小儿针具操作疼痛:两项随机临床试验。

Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials.

机构信息

General Pediatrics, Monash Children's Hospital, Clayton, Victoria, Australia; General Medicine, Royal Children's Hospital, Parkville, Victoria, Australia.

School of Clinical Sciences, Monash University and Monash Health, Clayton, Victoria, Australia.

出版信息

J Pediatr. 2019 Jun;209:160-167.e4. doi: 10.1016/j.jpeds.2019.02.034. Epub 2019 Apr 29.

DOI:10.1016/j.jpeds.2019.02.034
PMID:31047650
Abstract

OBJECTIVE

To assess the efficacy and safety of a virtual reality distraction for needle pain in 2 common hospital settings: the emergency department (ED) and outpatient pathology (ie, outpatient laboratory). The control was standard of care (SOC) practice.

STUDY DESIGN

In 2 clinical trials, we randomized children aged 4-11 years undergoing venous needle procedures to virtual reality or SOC at 2 tertiary Australian hospitals. In the first study, we enrolled children in the ED requiring intravenous cannulation or venipuncture. In the second, we enrolled children in outpatient pathology requiring venipuncture. In the ED, 64 children were assigned to virtual reality and 59 to SOC. In pathology, 63 children were assigned to virtual reality and 68 to SOC; 2 children withdrew assent in the SOC arm, leaving 66. The primary endpoint was change from baseline pain between virtual reality and SOC on child-rated Faces Pain Scale-Revised.

RESULTS

In the ED, there was no change in pain from baseline with SOC, whereas virtual reality produced a significant reduction in pain (between-group difference, -1.78; 95% CI, -3.24 to -0.317; P = .018). In pathology, both groups experienced an increase in pain from baseline, but this was significantly less in the virtual reality group (between-group difference, -1.39; 95% CI, -2.68 to -0.11; P = .034). Across both studies, 10 participants experienced minor adverse events, equally distributed between virtual reality/SOC; none required pharmacotherapy.

CONCLUSIONS

In children aged 4-11 years of age undergoing intravenous cannulation or venipuncture, virtual reality was efficacious in decreasing pain and was safe.

TRIAL REGISTRATION

Australia and New Zealand Clinical Trial Registry: ACTRN12617000285358p.

摘要

目的

评估虚拟现实分散注意力在 2 种常见医院环境(急诊科和门诊病理科,即门诊实验室)中用于针刺痛的疗效和安全性。对照组为标准护理(SOC)实践。

研究设计

在 2 项临床试验中,我们将 2 家澳大利亚三级医院需要静脉置管或静脉穿刺的 4-11 岁儿童随机分配到虚拟现实或 SOC 组。在第一项研究中,我们招募了急诊科需要静脉置管或静脉穿刺的儿童。在第二项研究中,我们招募了需要静脉穿刺的门诊病理科儿童。在急诊科,64 名儿童被分配到虚拟现实组,59 名儿童被分配到 SOC 组。在病理科,63 名儿童被分配到虚拟现实组,68 名儿童被分配到 SOC 组;2 名儿童在 SOC 组撤回同意,留下 66 名。主要终点是儿童评定面部疼痛量表修订版(Faces Pain Scale-Revised)从基线到虚拟现实和 SOC 的疼痛变化。

结果

在急诊科,SOC 组的疼痛没有从基线改变,而虚拟现实组的疼痛明显减轻(组间差异,-1.78;95%CI,-3.24 至-0.317;P=0.018)。在病理科,两组均从基线疼痛增加,但虚拟现实组疼痛明显减轻(组间差异,-1.39;95%CI,-2.68 至-0.11;P=0.034)。在两项研究中,共有 10 名参与者出现轻微不良事件,虚拟现实/SOC 组各有 5 名;均无需药物治疗。

结论

在 4-11 岁接受静脉置管或静脉穿刺的儿童中,虚拟现实在减轻疼痛方面有效且安全。

试验注册

澳大利亚和新西兰临床试验注册中心:ACTRN12617000285358p。

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