Feasibility and acceptability of biofeedback-based virtual reality for postoperative pain management in children and adolescents

项目总结 心身疗法，如生物反馈(BF)，是减轻儿童和成人疼痛的有效疗法。 虽然几十年来的文献支持使用BF来减轻疼痛，但BF目前还不能用于 术后一段时间作为一种资源丰富的干预手段。在新技术创新的帮助下，例如 虚拟现实(VR)，BF可以以一种引人入胜、资源密集型较少的方式交付，从而产生更多 可在更广泛的临床环境中应用的可获得的治疗。VR也证明了它的有效性 减轻疼痛，但由于注意力转移而导致的短暂疼痛减轻不足以治疗 长时间的急性疼痛体验。FOREVR(对参与VR的功能结果反应)是第一次 它是一种基于虚拟现实的高炉干预和交付系统。VR和BF(VR-BF)的结合使 VR的沉浸和娱乐与高炉的生理变化，以增强和维持各自 医疗模式的治疗效果。VR-BF是一种引人入胜的激励疗法，儿童可以进行 这在治疗几种疾病方面显示出了疗效。尽管有早期的有效证据， VR-BF是一种新的治疗方法，尚未用于围手术期护理，因此没有最佳的持续时间和 存在VR-BF的术前训练和术后应用的频率或确定的治疗方案。 这项研究标志着第一次评估VR-BF在围手术期环境中的实施和使用。 寻求建立以前的研究中没有解决的可衡量的里程碑。这两个人的目标是- 阶段性研究是为了了解如何实施一种新的VR-BF疗法来管理术后疼痛 孩子们。在进行VR-BF与主动对照的疗效试验之前，必须评估因素 这将影响VR-BF干预，从而影响VR-BF减轻疼痛和阿片类药物使用的有效性。 我们的中心假设是，在接受手术的儿童患者中使用VR-BF会导致中度 到剧烈疼痛将是可行和可接受的，这项试点试验的结果将为设计一个大型- VR-BF在这一患者群体中的规模疗效试验。具体目标：(1)完善治疗方案 使用FOREVR VR的儿童和儿童的术前教育和培训及术后VR-BF的应用 接受手术的青少年；和(2)进行先导性随机对照试验以评估可行性 儿童青少年围术期使用FOREVR VR-BF的可接受性 做手术。多学科研究团队，由麻醉师、疼痛专家、 临床心理学家、生物统计学家和临床试验设计专家是完成这些任务的理想人选。 研究目标。来自R34的数据将用于设计一项大规模、随机、临床疗效试验 VR-BF评估患有急性术后疼痛的儿童和青少年的疼痛和阿片类药物的减少。会的 提供关于VR-BF的术前教育和培训以及术后应用的见解，以努力 改善术后镇痛，减少阿片类药物和止痛药的使用，并协助疼痛和压力管理。

PROJECT SUMMARY Mind-body therapies, like biofeedback (BF), are effective treatments to decrease pain in children and adults. While decades of literature support the use of BF to decrease pain, BF is not currently available for use in the postoperative period as it is a resource-rich intervention. With the help of novel technologic innovations, like virtual reality (VR), BF can be delivered in an engaging, less resource-intensive manner, resulting in a more accessible therapy that can be applied in broader clinical settings. VR has also demonstrated efficacy to decrease pain, but transient reductions in pain due to the redirection of attention are insufficient to treat prolonged acute pain experiences. FOREVR VR (Functional Outcome Response to Engaging VR) is a first-of- its-kind, VR-based BF intervention and delivery system. Combining VR and BF (VR-BF) synergizes the immersion and entertainment of VR with the physiological modifications of BF to enhance and sustain each modality’s therapeutic effects. VR-BF is an engaging and motivating therapy that children can perform independently and that has shown efficacy in treating several disorders. Despite early evidence of efficacy, VR-BF is a new therapy and has not yet been employed in perioperative care, thus no optimal duration and frequency or defined treatment protocols for preoperative training and postoperative application of VR-BF exist. This study marks the first to assess the implementation and use of VR-BF in the perioperative setting and seeks to establish measurable milestones that have not been addressed in prior studies. The goal of this two- phase study is to understand how to implement a novel VR-BF therapy for postoperative pain management in children. Before conducting an efficacy trial of VR-BF versus active control, it is imperative to assess factors that will impact the VR-BF intervention and, consequently, the efficacy of VR-BF to reduce pain and opioid use. Our central hypothesis is that the use of VR-BF in pediatric patients undergoing surgery resulting in moderate to severe pain will be feasible and acceptable, and that findings from this pilot trial will inform design of a large- scale efficacy trial of VR-BF in this patient population. Specific aims: (1) Refine a treatment protocol for preoperative education and training and postoperative application of VR-BF using FOREVR VR in children and adolescents undergoing surgery; and (2) Conduct a pilot randomized controlled trial to assess the feasibility and acceptability of perioperative use of VR-BF using FOREVR VR in children and adolescents undergoing surgery. The multidisciplinary research team, a unique collaboration of an anesthesiologist, pain experts, clinical psychologists, a biostatistician, and a clinical trial design expert; are ideally suited to accomplish these research goals. Data from this R34 will inform design of a large-scale, randomized, clinical efficacy trial using VR-BF to assess pain and opioid reduction in children and adolescents with acute postoperative pain. It will provide insight on preoperative education and training and postoperative application of VR-BF, in efforts to improve postoperative analgesia, reduce opioid and analgesic use, and assist in pain and stress management.