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 父母治愈倡议研究旨在评估身临其境虚拟现实（VR）对患者的影响 慢性下背部疼痛（CLBP）患者中报告的结果（PRO），活动指标和阿片类药物的使用。 为了补充父母的研究，这种混合方法研究（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构成实施VR疗法的障碍 干预以及VR干预的文化看法与元数据和患者的关系如何 报告的结果（专业人士）。 客观的 该研究的目的是1）了解潜水员跨潜水员实施治疗技术的任何障碍 人口； 2）了解文化差异如何影响VR含量的感知； 3）探索相关性 在不同的群体中使用治疗性VR技术的不同群体之间； 4）发现优点如何关联 使用收集的定性数据。该研究的总体目标是更好地了解文化差异和 有关治疗性VR的数字鸿沟，因此最终将来的治疗性沉浸式VR应用程序和 研究的设计将更加公平和包容。 方法 定性一对一的半结构化访谈将与潜水员选择的参与者一起进行 完成了VR干预。患者招募将有选择性以最大程度地提高多样性 种族/种族（黑色，西班牙裔，白色），性别，社会经济地位和地理位置 由Zip代码（农村，郊区，城市）。访谈将编码为主要和次要概念 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 描述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 与参与者从VR耳机中提取的参与者的优点和元数据相关，包括使用时间， 在整个体验中，使用时间和头部旋转的框架输出。至少五个参与者将 被招募到上述每个指定类别中，估计总招募二十 参与者。