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: 10300251
• 负责人: Vanessa Anne Olbrecht
• 金额: $ 24.14万
• 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/10300251
• 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; improved; innovation; insight; 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 思维体疗法（例如生物反馈（BF））是减轻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减轻疼痛，但BF目前尚不可用于 术后时期，因为这是一种资源丰富的干预措施。在新颖的技术创新的帮助下 虚拟现实（VR），BF可以以引人入胜的，资源密集的方式交付，导致更多 可以在更广泛的临床环境中应用的可访问疗法。 VR还证明了效率 减轻疼痛，但由于注意力的重定向而导致疼痛的短暂减轻不足以治疗 长时间的急性疼痛经历。 ForeVr VR（对参与VR的功能结果响应）是首个 基于VR的BF干预和交付系统。将VR和BF（VR-BF）结合在一起 通过BF的身体修饰来浸入VR和娱乐，以增强和维持每个 模态的治疗作用。 VR-BF是一种引人入胜且激励的疗法，儿童可以表演 独立，这表明在治疗多种疾病方面有效率。尽管早期有效率的证据， VR-BF是一种新疗法，尚未在定期护理中雇用，因此没有最佳持续时间和 存在术前培训和术后使用VR-BF的频率或定义的治疗方案。 这项研究标志着第一个评估VR-BF在周期性环境中的实施和使用和使用 寻求建立可衡量的里程碑，这些里程碑尚未在先前的研究中解决。这个两个目标的目标 阶段研究是了解如何在术后疼痛管理中实施新型的VR-BF疗法 孩子们。在进行VR-BF与主动控制的有效试验之前，必须评估因素 这将影响VR-BF干预措施，因此，VR-BF的效率减轻了疼痛和OID的使用。 我们的中心假设是在接受手术的小儿患者中使用VR-BF，导致现代 严重的疼痛将是可行的和可接受的，这项试验试验的发现将为您的设计提供大量的设计。 VR-BF在该患者人群中的规模效率试验。具体目的：（1）完善针对的治疗方案 使用ForeVR VR在儿童和 青少年接受手术； （2）进行试验随机对照试验以评估可行性 以及在儿童和青少年中使用ForeVR VR定期使用VR-BF的可接受性 外科手术。多学科研究团队是麻醉师，疼痛专家的独特合作， 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 研究目标。此R34的数据将为设计提供大规模，随机，临床效率试验的设计 VR-BF评估急性术后疼痛的儿童和青少年的疼痛和疼痛减轻。会 提供有关VR-BF的术前教育和培训以及术后应用的见解，以便 改善术后镇痛，减少OIOID和镇痛药，并有助于疼痛和压力管理。