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

虚拟现实治疗慢性腰痛的随机对照试验，以改善患者报告的结果和身体活动（HEAL 补充）

• 批准号: 10650652
• 负责人: Brennan Spiegel
• 金额: $ 8.16万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10650652
• 关键词: Age; Black race; Categories; Chronic low back pain; Code; Data; Equity; Ethnic Origin; Future; Gender; Geographic Locations; Goals; Head; Helping to End Addiction Long-term; Hispanic; Intervention; Interview; Learning; Medical; Metadata; Minor; Output; Parents; Participant; Patient Outcomes Assessments; Patient Recruitments; Patients; Perception; Physical activity; Population Heterogeneity; Qualitative Methods; Race; Randomized, Controlled Trials; Research; Research Methodology; Research Proposals; Risk; Rotation; Rural; Socioeconomic Status; Specific qualifier value; Structure; Technology; Therapeutic; Therapeutic Intervention; Therapeutic Uses; addiction; chronic pain; design; digital; digital treatment; effectiveness evaluation; experience; improved; opioid use; prescription opioid; recruit; side effect; suburb; time use; virtual reality; virtual reality environment; virtual reality headset; virtual reality intervention

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.

抽象的 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）。 客观的 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 人群；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 之间的关联 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选择的参与者进行 完成 VR 干预后，将有选择性地招募患者，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）进行的采访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。我们还将开发一个网络来生成代码计数直方图。 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， 至少有五名参与者将在整个体验过程中了解使用时间以及头部旋转的逐帧输出。 上述每一类具体招募人员，估计招募总数为二十人 参与者。