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 报告的结果（PRO），活动指标和阿片类药物的使用与慢性下腰痛（cLBP）患者。 为了补充母研究，这一混合方法研究（MMR）的建议将阐明如何 种族/民族、性别、社会经济地位和年龄可能对实施VR治疗构成障碍 干预，以及VR干预的文化感知如何与Meta数据和患者相关 报告结果（PRO）。 目的 该研究的目的是：1）了解在不同的医疗领域实施治疗性VR技术的任何障碍 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技术之间的关系;以及4）发现PRO如何关联 收集的定性数据。这项研究的首要目标是更好地了解文化差异， 关于治疗VR的数字鸿沟，以便最终未来的治疗沉浸式VR应用， 研究的设计将更加公平和包容。 方法 定性的一对一半结构化面试将与不同选择的参与者进行， 完成了VR干预。患者招募将是有选择性的，以最大限度地提高多样性， 人种/种族（黑人、西班牙裔、白色）、性别、社会经济地位和确定的地理位置 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， 用于为上述每个类别生成代码计数直方图。我们还将建立一个网络， 描绘一个描述概念的广度和深度的框架。最后，编码的定性数据将 与参与者的PRO和从VR头戴设备提取的Meta数据（包括使用持续时间）相关， 使用时间和整个体验中头部旋转的逐帧输出。至少有五名参与者将 被招募到上述每个特定类别，估计总招募人数为20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.