A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

在儿科烧伤换药期间，疼痛管理是重中之重。虽然虚拟现实(VR)可以缓解疼痛 烧伤护理过程中的管理已经在临床试验中研究了20多年，仍然没有证据 在从医疗环境过渡到医疗环境的过程中，智能手机VR对疼痛管理的有效性 居家烧伤护理。这项研究的长期目标是使用创新的、以患者为中心的智能手机VR来改善 患者的经历和结果。根据我们发布的研究结果，我们的创新VR止痛工具 (VR-PAT)可以导致90名患者中有临床意义的疼痛减轻(总疼痛减少47.1%) 儿科烧伤患者在本院门诊就诊，总体目标是(I)测定VR-PAT 在家庭烧伤护理期间减少疼痛管理和阿片类药物使用的有效性，以及(Ii) 确定可能影响VR-PAT广泛使用的潜在促进者和障碍。中心假设是 VR-PAT可以诱导临床上有意义的疼痛减轻(30%)，在重复的家庭烧伤敷料更换。 理由是VR-PAT在减少疼痛和阿片类药物使用方面的有效性的确定， 安全性和患者/家人的参与度可能会为智能手机VR提供一个强大的科学框架 可由家庭在家中广泛而轻松地实施。两个具体目标：1)评估虚拟现实的有效性- 在家庭烧伤护理期间用于疼痛管理和阿片类止痛药减少的PAT；2)检查 患者和照顾者在重复家庭烧伤敷料时使用VR-PAT的持续参与度 改变。将在200名儿童烧伤患者中进行两组随机临床试验 (6-17岁)。来自干预组(VR-PAT)和对照组(标准)的患者和照顾者 护理)将在家中完成日常的烧伤敷料更换。将测量总体疼痛和最严重的疼痛 在每次烧伤换药期间使用标准化的疼痛视觉模拟评分(VAS)，为期1周。面积 根据儿童报告的总疼痛曲线(AUC-VAS)和吗啡相当的疼痛总剂量 药物(AUC-OC)将被整合以计算综合疼痛评分强度和阿片类药物消耗 (PIOC)评分为目标1的主要结果。目标2为不良事件、VR体验和参与度 将在VR组中进行衡量，以具体应对设计mHealth干预措施的挑战 美国国家医学院(NAM)认为需要更多的研究。该项目具有创新性。 因为它不仅测试创新的智能手机VR，以优化患者在治疗期间的体验和结果- 除了家庭护理，还将开发一种新的复合疼痛评估统计方法，用于更广泛的烧伤研究。 这项拟议的研究具有重要意义，因为它有望提供强大的科学性和实用性 在家庭烧伤护理期间采用智能手机VR进行疼痛管理的理由。最终，这样的 Knowledge有可能将智能手机VR作为一种有效且安全的非药物疼痛 由家庭照顾者从医疗环境向居家护理过渡期间的管理方法。

Pain management is a top priority during pediatric burn dressing changes. Although virtual reality (VR) for pain management during burn care has been studied in clinical trials for more than 2 decades, there is still no evidence of the effectiveness of smartphone VR for pain management during the care transition from medical settings to at-home burn care. This study’s long-term goal is to use innovative, patient-centric smartphone VR to improve patient experience and outcomes. Based on our published findings that our innovative VR Pain Alleviation Tool (VR-PAT) could result in a clinically meaningful reduction in pain (47.1% overall pain reduction) among 90 pediatric burn patients treated at our hospital outpatient clinic, the overall objectives are to (i) determine VR-PAT effectiveness for pain management and opioid medication use reduction during at-home burn care, and (ii) to identify potential facilitators and barriers that could affect wide use of VR-PAT. The central hypothesis is that VR-PAT can induce clinically meaningful pain reduction (>30%) during repeated at-home burn dressing changes. The rationale is that a determination of the VR-PAT effectiveness at reducing pain and opioid medication use, safety, and patient/family engagement is likely to offer a strong scientific framework by which a smartphone VR can be implemented widely and easily by families at-home. Two specific aims : 1) Evaluate effectiveness of VR- PAT for pain management and opioid pain medication reduction during at-home burn care; 2) Examine continuous engagement of patients and caregivers with VR-PAT during repeated at-home burn dressing changes. A two-group randomized clinical trial will be implemented among a total of 200 pediatric burn patients (6-17 years old). Patients and caregivers from both the intervention group (VR-PAT) and control group (standard care) will complete their daily burn dressing changes at home. Overall pain and worst pain will be measured using a standardized pain Visual Analogue Scale (VAS) during each burn dressing change for 1 week. Area under the curve for child reported overall pain (AUC-VAS) and morphine equivalent total dose of pain medications (AUC-OC) will be integrated to calculate composite pain score intensity and opioid consumption (PIOC) score as the primary outcome for Aim 1. For Aim 2, adverse events, VR experience and engagement will be measured in the VR group to specifically address challenges in designing mHealth interventions that the U.S. National Academy of Medicine (NAM) identified as needing more research. This project is innovative because it not only tests an innovative smartphone VR to optimize patient’s experience and outcomes during at- home care but will also develop a novel composite pain assessment statistical method for broader burn research. The proposed research is significant because it is expected to provide strong scientific as well as practical justifications for implementing smartphone VR for pain management during at-home burn care. Ultimately, such knowledge has the potential of offering smartphone VR as an effective and safe non-pharmaceutical pain management approach during care transition from medical settings to at-home care by family caregivers.