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

基于生物反馈的虚拟现实用于儿童和青少年术后疼痛管理的可行性和可接受性

• 批准号: 10488208
• 负责人: Vanessa Anne Olbrecht
• 金额: $ 23.25万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10488208
• 关键词: Abdominal Pain; Absence of pain sensation; Acute; Acute Pain; Acute pain management; Address; Adherence; Adolescent; Adult; Adverse effects; Analgesics; Area; Attention; Biofeedback; Biofeedback Training; Breathing; Caring; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Design; Collaborations; Complementary therapies; Consumption; Data; Dependence; Disease; Dose; Educational process of instructing; Enrollment; Feedback; Fibromyalgia; Foundations; Frequencies; Future; Goals; Human Resources; Immersion; Instruction; Interdisciplinary Study; Intervention; Interview; Knowledge; Laparotomy; Literature; Measurable; Methodology; Migraine; Mind-Body Intervention; Modality; Modification; Morbidity - disease rate; Nonpharmacologic Therapy; Operative Surgical Procedures; Opioid; Opioid Analgesics; Pain; Pain Research; Pain management; Patient Education; Patients; Perioperative; Perioperative Care; Pharmaceutical Preparations; Phase; Physiological; Physiology; Population; Postoperative Pain; Postoperative Period; Protocols documentation; Psychologist; Questionnaires; Randomized; Randomized Controlled Trials; Recovery; Research; Resources; Risk; Sampling; Schedule; Self-Direction; Spine surgery; Structure; System; Techniques; Technology; Therapeutic Effect; Time; Training; Training and Education; Treatment Protocols; United States National Institutes of Health; Vulnerable Populations; acceptability and feasibility; active control; addiction; arm; base; behavior change; body-mind; clinical practice; cost; design; effective therapy; efficacy clinical trial; efficacy trial; experience; functional outcomes; implementation evaluation; improved; innovation; insight; intervention delivery; multimodality; novel; novel therapeutics; opioid exposure; opioid sparing; opioid use; pain reduction; patient population; pediatric patients; pilot trial; procedural pain; recruit; respiratory; response; satisfaction; stress management; technological innovation; treatment arm; usability; virtual reality; virtual reality environment

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.

项目摘要 身心疗法，如生物反馈（BF），是减少儿童和成人疼痛的有效治疗方法。 虽然数十年的文献支持使用BF来减轻疼痛，但BF目前尚不可用于 因为它是一种资源丰富的干预措施。借助新颖的技术创新，如 虚拟现实（VR），BF可以以一种引人入胜、资源密集度较低的方式提供，从而带来更高的 可以在更广泛的临床环境中应用的可获得的治疗。VR还证明了其有效性， 减少疼痛，但由于注意力的重新定向而导致的疼痛短暂减少不足以治疗 长时间的急性疼痛。FOREVR VR（参与VR的功能结果响应）是第一个 基于VR的BF干预和输送系统。结合VR和BF（VR-BF）可以协同 VR的沉浸感和娱乐性与BF的生理变化相结合，以增强和维持两者 的治疗效果。VR-BF是一种儿童可以进行的吸引人和激励性治疗 并且已经显示出治疗几种疾病的功效。尽管有早期的疗效证据， VR-BF是一种新疗法，尚未用于围手术期护理，因此没有最佳持续时间， 存在用于VR-BF的术前训练和术后应用的频率或定义的治疗方案。 本研究首次评估了VR-BF在围手术期环境中的实施和使用， 寻求建立以前研究中没有涉及的可衡量的里程碑。这两个人的目标- 阶段研究是为了了解如何实施一种新的VR-BF治疗术后疼痛管理， 孩子在进行VR-BF与活性对照的疗效试验之前，必须评估以下因素： 这将影响VR-BF干预，从而影响VR-BF减少疼痛和阿片类药物使用的疗效。 我们的中心假设是，在接受手术的儿科患者中使用VR-BF导致中度 严重疼痛将是可行的和可接受的，从这个试点试验的结果将告知设计一个大的- 在该患者人群中进行VR-BF的规模有效性试验。具体目标：（1）完善治疗方案， 术前教育和培训以及使用FOREVR VR的VR-BF在儿童中的术后应用， 接受手术的青少年;（2）进行一项初步随机对照试验，以评估可行性 在接受FOREVR VR的儿童和青少年中围手术期使用VR-BF的可接受性 手术多学科研究团队是麻醉师、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;非常适合完成这些任务 研究目标。来自该R34的数据将为设计一项大规模、随机、临床疗效试验提供信息， VR-BF评估儿童和青少年急性术后疼痛的疼痛和阿片类药物减少。它将 提供术前教育和培训以及VR-BF术后应用的见解，努力 改善术后镇痛，减少阿片类药物和镇痛药使用，并协助疼痛和压力管理。