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 Parent Hear Initiative研究旨在评估沉浸式虚拟现实(VR)对患者的影响 慢性下腰痛(CLBP)患者的报告结果(PRO)、活动指标和阿片类药物的使用。 作为对父研究的补充，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，以及对VR干预的文化认知可能如何与元数据和患者相关 报告结果(PRO)。 客观化 这项研究的目的是1)了解在不同领域实施治疗性VR技术的任何障碍 2)了解文化差异如何影响人们对虚拟现实内容的感知；3)探索两者之间的相关性 不同的群体如何不同地使用治疗性VR技术；以及4)了解专业人员如何相互关联 利用收集到的定性数据。这项研究的首要目标是更好地了解文化差异和 关于治疗性VR的数字鸿沟，因此最终未来的治疗性沉浸式VR应用和 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的参与者进行，这些参与者包括 完成VR干预。患者招募将是有选择性的，以在以下方面最大限度地多样化 种族/民族(黑人、西班牙裔、白人)、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)。采访将被编码为主要和次要概念，这将是 用于为上述每个类别生成代码计数直方图。我们还将开发一个网络来 描绘一个框架，描述概念的广度和深度。最后，编码的定性数据将是 与参与者的专业和从VR头戴式耳机提取的包括使用持续时间的元数据相关， 使用时间，并逐帧输出头部旋转的整个体验。至少有五名参与者将 拟征聘到上述每个具体职类，估计征聘总数为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.