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: 10654021
• 负责人: Vanessa Anne Olbrecht
• 金额: $ 22.75万
• 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/10654021
• 关键词: Abdominal Pain; Absence of pain sensation; Acute; Acute Pain; Acute pain management; Address; Adherence; Adolescent; Adult; Adverse effects; Analgesics; Area; Biofeedback; Biofeedback Training; Breathing; Caring; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Design; Collaborations; Complementary therapies; Consumption; Data; Dependence; Disease; Disparity population; 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; Pain; Pain Measurement; 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; behavior change; clinical practice; cost; design; directed attention; effective therapy; efficacy clinical trial; efficacy trial; experience; functional outcomes; heart rate variability; implementation evaluation; improved; innovation; insight; mind/body; multimodality; new technology; 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; synergism; technological innovation; treatment arm; usability; virtual reality; virtual reality environment; virtual reality intervention

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。 而数十年的文献支持使用BF减轻疼痛 在新颖的技术创新的帮助下，就像，喜欢，喜欢，喜欢，一样。 虚拟现实（VR），BF可以以英语，资源密集的方式交付 VR还证明了效力 减轻疼痛，但由于注意力正式toreat toreat而引起的疼痛瞬变 急性疼痛经历。 基于VR的BF INT交付系统。 通过BF的生理修饰来浸入VR和娱乐以增强和维持每个 模态的治疗效果。 独立，并在治疗多种疾病方面施加了功效。 VR-BF是一种新疗法，尚未在围手术期护理中使用，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局限环境中VR-BF的含义和VR-BF的标志 寻求建立可衡量的里程碑，这些里程碑在先前的研究中没有解决。 阶段研究是要了解如何实施一种新型的VR-BF疗法，以进行术后疼痛管理 儿童。 这将影响VR-BF干预措施，因此VR-BF减少疼痛和阿片类药物使用的功效。 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 严重的疼痛将是可行的和可接受的，试验试验的发现将为大型设计提供信息。 VR-BF在该患者人群中的比例疗效。 使用ForeVR VR在儿童和 接受手术的青少年；（2）进行飞行员随机对照试验 在儿童和青少年中，使用ForeVR VR对围手术期使用VR-BF的可接受性 手术。多学科研究团队，麻醉专家的独特合作 临床心理学家，一名生物学家和临床试验设计专家； 研究目标。 VR-BF评估患有急性术后儿童和青少年的疼痛和阿片类药物的修复。 提供有关VR-BF的术前教育和培训以及术后应用的见解， 改善术后镇痛，减少阿片类药物和镇痛药，并有助于和压力管理。

项目成果

Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial.

• DOI: 10.1136/bmjopen-2022-071274
• 发表时间: 2023-01-25
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Orgil Z;Johnson L;Karthic A;Williams SE;Ding L;Kashikar-Zuck S;King CD;Olbrecht VA
• 通讯作者: Olbrecht VA

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery.

• DOI: 10.1016/j.dib.2023.109331
• 发表时间: 2023-08
• 期刊: Data in brief
• 影响因子: 1.2