利用虚拟现实技术分散注意力在急诊室进行儿童静脉输液的舒适度改善(DEVINCI):一项初步实用随机对照试验。
Distraction in the Emergency department using Virtual reality for INtravenous procedures in Children to Improve comfort (DEVINCI): a pilot pragmatic randomized controlled trial.
机构信息
Department of Pediatric Emergency Medicine, CHU Sainte-Justine, 3175, Ch. de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.
CHU Sainte-Justine Research Centre, Université de Montréal, Montréal, Canada.
出版信息
CJEM. 2021 Jan;23(1):94-102. doi: 10.1007/s43678-020-00006-6. Epub 2020 Dec 23.
OBJECTIVES
Intravenous (IV) procedures cause pain and distress in the pediatric emergency department (ED). We studied the feasibility and acceptability of virtual reality distraction for patient comfort during intravenous procedures.
METHODS
Children were randomized to a control (standard care) or intervention group (standard care + virtual reality). Thresholds for feasibility and acceptability (primary outcomes) were determined through a priori established criteria. The level of procedural pain (principal clinical outcome) and distress, as well as memory of pain at 24 h were collected and reported as medians (Q1, Q3) for each group.
RESULTS
63 patients were enrolled, with a high rate of recruitment (78.8%) and game completion (90.3%). Patients, parents and, healthcare providers reported high satisfaction levels. There were no serious adverse events. Five of the 30 patients (16.7%) exposed to virtual reality reported mild side effects. Self-reported procedural pain (verbal numerical rating scale: 3 (1, 6)/10 vs 3 (1, 5.5)/10, p = 0.75) was similar between groups. Further exploratory clinical measures were reported for the intervention and control groups, respectively: self-rated distress during the procedure (Child Fear Scale: 1 (0, 2)/4 vs 2 (0, 3)/4); distress evaluated by proxy during the procedure (Procedure Behavior Check List: 8 (8, 9)/40 vs 10 (8, 15)/40); memory of pain at 24 h (VNRS: 2 (1, 3)/10 vs 4 (2, 6.5)/10).
CONCLUSION
The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED. Occasional mild, self-resolving side effects were observed in the intervention group. Self-reported pain during the procedure was similar between groups. CLINICALTRIALS.
GOV IDENTIFIER
NCT03750578.
目的
静脉(IV)程序会在儿科急诊部门(ED)引起疼痛和不适。我们研究了虚拟现实分散注意力在 IV 程序期间患者舒适度的可行性和可接受性。
方法
将儿童随机分配到对照组(标准护理)或干预组(标准护理+虚拟现实)。通过事先确定的标准确定可行性和可接受性的阈值(主要结果)。收集并报告每个组的程序疼痛(主要临床结果)和不适程度,以及 24 小时时的疼痛记忆中位数(Q1、Q3)。
结果
63 名患者入组,招募率高(78.8%),游戏完成率高(90.3%)。患者、家长和医疗保健提供者报告满意度高。没有严重不良事件。暴露于虚拟现实的 30 名患者中的 5 名(16.7%)报告有轻度副作用。自我报告的程序疼痛(口头数字评分量表:3(1,6)/10 与 3(1,5.5)/10,p=0.75)在两组之间相似。分别为干预组和对照组报告了进一步的探索性临床措施:手术过程中的自我评估困扰(儿童恐惧量表:1(0,2)/4 与 2(0,3)/4);手术过程中由代理人评估的困扰(手术行为检查表:8(8,9)/40 与 10(8,15)/40);24 小时时的疼痛记忆(VNRS:2(1,3)/10 与 4(2,6.5)/10)。
结论
在儿科 ED 中,将虚拟现实添加到标准护理中对于 IV 程序中的疼痛和不适管理是可行且可接受的。干预组观察到偶尔出现的轻度、自限性副作用。组间手术过程中的自我报告疼痛相似。临床试验。
政府标识符
NCT03750578。