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

智能手机虚拟现实在烧伤护理过渡期间疼痛管理的随机临床试验

基本信息

批准号：
10708914
负责人：
HENRY XIANG
金额：
$ 36.8万
依托单位：
RESEARCH INST NATIONWIDE CHILDREN'S HOSP
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-30 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10708914
关键词：
Randomized Clinical Trial Smartphone Virtual

项目摘要

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.

疼痛管理是儿科烧伤敷料更换过程中的首要任务。虽然虚拟现实（VR）对于疼痛烧伤护理期间的管理已经在临床试验中研究了20多年，仍然没有证据表明智能手机VR在从医疗环境到护理过渡期间用于疼痛管理的有效性家庭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来改善患者体验和结果。根据我们发表的研究结果，我们的创新VR疼痛缓解工具（VR-PAT）可导致90例患者中具有临床意义的疼痛减轻（总体疼痛减轻47.1%）。在我院门诊治疗的小儿烧伤患者，总体目标是（i）确定VR-PAT 在家庭烧伤护理期间疼痛管理和阿片类药物使用减少的有效性，以及（ii）确定可能影响VR-PAT广泛使用的潜在促进因素和障碍。核心假设是， VR-PAT可以在反复在家更换烧伤敷料期间诱导具有临床意义的疼痛减轻（>30%）。其基本原理是，确定VR-PAT在减少疼痛和阿片类药物使用方面的有效性，安全性和患者/家属的参与可能会提供一个强大的科学框架，可以在家庭中广泛且容易地实施。两个具体目标：1）评估VR的有效性- PAT用于在家烧伤护理期间的疼痛管理和阿片类止痛药减少; 2）检查在反复在家烧伤敷料期间，患者和护理人员持续参与VR-PAT 变化将在总共200名儿童烧伤患者中实施两组随机临床试验 (6-17岁）。干预组（VR-PAT）和对照组（标准）的患者和护理人员护理）将在家中完成每日烧伤敷料更换。将测量总体疼痛和最严重疼痛在每次烧伤敷料更换期间使用标准化疼痛视觉疼痛量表（VAS），持续1周。区域儿童报告的总体疼痛（AUC-VAS）和吗啡等效疼痛总剂量的曲线下面积将对药物（AUC-OC）进行积分，以计算复合疼痛评分强度和阿片类药物消耗量（PIOC）评分作为目标1的主要结局。对于目标2，不良事件、VR体验和参与度将在VR组中进行测量，以专门解决设计移动健康干预措施的挑战，美国国家医学院（NAM）认为需要更多的研究。这个项目是创新的因为它不仅测试了创新的智能手机VR，以优化患者在治疗过程中的体验和结果，家庭护理，但也将开发一种新的复合疼痛评估统计方法，更广泛的烧伤研究。这项研究具有重要意义，因为它有望提供强有力的科学性和实用性在家庭烧伤护理期间实施智能手机VR进行疼痛管理的理由。最终，这样的知识有可能提供智能手机VR作为一种有效和安全的非药物疼痛在从医疗环境到家庭护理的护理过渡期间，由家庭护理人员采取管理办法。