Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity (HEAL Supplement)

摘要 背景 母公司 HEAL Initiative 研究旨在评估沉浸式虚拟现实 (VR) 对患者的影响 报告慢性腰痛 (cLBP) 患者的结局 (PRO)、活动指标和阿片类药物使用情况。 为了补充母研究，这项混合方法研究 (MMR) 提案将阐明如何 种族/民族、性别、社会经济地位和年龄可能会对实施 VR 治疗造成障碍 干预，以及 VR 干预的文化认知如何与元数据和患者相关联 报告结果（PRO）。 目的 该研究的目的是 1) 了解在不同领域实施治疗性 VR 技术的任何障碍 人口； 2) 了解文化差异如何影响 VR 内容的感知； 3）探索相关性 不同群体如何不同地使用治疗性 VR 技术； 4) 发现 PRO 如何相互关联 与收集的定性数据。该研究的总体目标是更好地了解文化差异和 治疗性 VR 的数字鸿沟，最终使未来的治疗性沉浸式 VR 应用和 研究将被设计得更加公平和包容。 方法 定性的一对一半结构化访谈将与不同的参与者进行 完成VR干预。患者招募将有选择性，以最大限度地提高多样性 种族/民族（黑人、西班牙裔、白人）、性别、社会经济地位和地理位置 按邮政编码（农村、郊区、城市）。访谈将被编码为主要和次要概念，这些概念将 用于生成上述每个类别的代码计数直方图。我们还将开发一个网络 描绘一个描述概念广度和深度的框架。最后，编码的定性数据将是 与参与者的 PRO 和从 VR 耳机中提取的元数据（包括使用时间）相关联， 使用时间，以及整个体验过程中头部旋转的逐帧输出。至少有五名参与者 上述每一类别均应招募，估计招募总数为二十人 参与者。

Abstract Background The parent HEAL Initiative study was designed to assess the impact of immersive virtual reality (VR) on patient reported outcomes (PROs), activity metrics, and opioid use among patients with chronic lower back pain (cLBP). To supplement the parent study, this mixed methods research (MMR) proposal will shed light on how race/ethnicity, gender, socioeconomic status, and age may pose barriers to implementing the VR therapeutic intervention, and how cultural perceptions of the VR intervention may correlate with meta data and patient reported outcomes (PROs). Objective The study’s aims are to 1) understand any barriers to implementing therapeutic VR technologies across diverse populations; 2) learn how cultural differences influence perception of the VR content; 3) explore the correlations between how diverse groups differentially use therapeutic VR technologies; and 4) discover how PROs correlate with the collected qualitative data. The study’s overarching goal is to better understand cultural differences and the digital divide regarding therapeutic VR so that ultimately future therapeutic immersive VR applications and research will be designed to be more equitable and inclusive. Methods Qualitative one-on-one semi-structured interviews will be performed with a diverse selection of participants who completed the VR intervention. Patient recruitment will be selective to maximize diversity in terms of race/ethnicity (Black, Hispanic, White), gender, socioeconomic status, and geographic location as determined by zip-code (rural, suburban, urban). The interviews will be coded into major and minor concepts which will be used to generate code count histograms for each of the above categories. We will also develop a network to depict a framework describing the breadth and depth of concepts. Finally, the coded qualitative data will be correlated with the participants’ PROs and meta data extracted from the VR headset including duration of use, time of use, and frame-by-frame output of head rotation throughout the experience. At least five participants will be recruited into each of the above specified categories, with an estimated total recruitment of twenty participants.