Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned.
Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned.
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DOI：
10.1371/journal.pdig.0000231
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发表时间：
2023-09
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阿片类药物是美国烧伤中心最常用的止痛药，用于控制伤口护理期间的严重手术疼痛。对长期使用阿片类药物的担忧促使人们探索非药物干预措施，如虚拟现实（VR），用于程序性疼痛管理。本初步研究的主要目的是评价VR疼痛缓解治疗在减少成人烧伤患者在烧伤敷料更换过程中感知疼痛方面的可行性和有效性。在2019年5月至2020年2月期间，从美国烧伤协会认证的烧伤中心的住院部招募了18-70岁的成年患者，并随机分配到三个组中的一个。主动VR参与者玩了四个VR游戏;被动VR参与者沉浸在没有交互元素的相同VR环境中;以及标准护理对照组。筛选了71例患者的合格性，33例被认为有资格获得知情同意，其中14例同意参加本研究。在这14例患者中，4例被随机分配到主动VR组，4例被分配到被动VR组，6例被分配到对照组。在所有三次敷料更换中，主动VR参与者自我报告的总体疼痛最低（敷料1 = 41.3，敷料2 = 61.0，敷料3 = 72.7），被动VR参与者自我报告的总体疼痛最高（敷料1 = 58.3，敷料2 = 74.5，敷料3 = 89.0）。主动VR在第一次和最后一次敷料时的自我报告最严重疼痛最低（分别为64.3和92.2），但对照组在第二次敷料时的自我报告最严重疼痛最低（71.3）。VR是一种用于疼痛分散的有用的非药理学工具，但设计和实施临床研究在现实世界的医疗环境中面临许多挑战。这项研究的经验教训对其他研究人员未来的VR研究具有重要意义。试用注册：ClinicalTrials.gov标识符：NCT 04545229。在本文中，我们描述了我们的经验进行随机临床试验，使用虚拟现实作为疼痛分散在住院烧伤护理。这项初步研究旨在评估虚拟现实作为疼痛分散治疗的可行性和有效性。在多种烧伤护理程序中比较了三个干预组。我们在10个月的招募中招募了14名患者。虽然我们的样本量太小，无法考虑显著性检验，但我们确实发现，积极参与虚拟现实的一组报告的疼痛比其他两组少。我们记录了在烧伤敷料更换过程中使用虚拟现实的许多挑战，包括受伤的严重程度和对高剂量阿片类药物的需求，对虚拟现实缺乏兴趣，住院伤口护理的独特性质以及与游戏互动的方法。COVID-19亦为我们的研究带来招募限制。我们提出了规避这些挑战的方法，为未来的研究人员在设计成人患者的虚拟现实研究。
Opioids are the most frequently used pain medications by US burn centers to control severe procedural pain during wound care. Concerns for long-term opioid use have prompted the exploration of non-pharmaceutical interventions, such as virtual reality (VR), for procedural pain management. The primary objective of this pilot study was to evaluate the feasibility and efficacy of VR pain alleviation treatment in reducing adult burn patients’ perceived pain during burn dressing changes. Adult patients aged 18–70 years were recruited from the inpatient unit of a single American Burn Association–verified burn center between May 2019 and February 2020 and randomly assigned to one of three arms. Active VR participants played four VR games; passive VR participants were immersed in the same VR environment without the interaction elements; and a standard of care control group. 71 patients were screened for eligibility and 33 were deemed eligible to approach for informed consent, with 14 agreeing to participate in this study. Of these 14 patients, 4 were randomly assigned to the active VR, 4 to the passive VR, and 6 to the control group. Self-reported overall pain was lowest among participants in the active VR (dressing 1 = 41.3, dressing 2 = 61.0, and dressing 3 = 72.7) and highest among participants in the passive VR (dressing 1 = 58.3, dressing 2 = 74.5, and dressing 3 = 89.0) across all three dressing changes. Self-reported worst pain was lowest among the active VR at the first and last dressing (64.3 and 92.2, respectively), but the control group has the lowest self-reported worst pain at the second dressing (71.3). VR is a useful non-pharmacological tool for pain distraction but designing and implementing clinical research studies face many challenges in real-world medical settings. Lessons from this study have important implications for future VR studies by other researchers. Trial Registration: ClinicalTrials.gov Identifier: NCT04545229. In this paper we describe our experience conducting a randomized clinical trial using virtual reality as a pain distraction during inpatient burn care. This pilot study was designed to evaluate feasibility and efficacy of virtual reality as a pain distraction treatment. Three intervention groups were compared across multiple burn care procedures. We enrolled 14 patients across 10 months of recruitment. While our sample size was too small to consider significance testing, we did find that the group with active virtual reality participation reported less pain than those in the other two groups. We documented many challenges with using virtual reality during burn dressing changes, including the severity of injuries and the need for high-dose opioids, lack for interest in virtual reality, the unique nature of inpatient wound care, and methods of interacting with a game. COVID-19 also created recruitment restriction for our study. We proposed methods for circumventing these challenges for future researchers when designing virtual reality studies among adult patients.