Effectiveness of an mHealth psychosocial intervention to prevent transition from acute to chronic postsurgical pain in adolescents

急性和慢性手术后疼痛(CPSP)是一生中一个主要的健康问题。接受侵入性肌肉骨骼手术的青少年尤其危险，20%的青少年患上CPSP并伴随着健康相关生活质量(HRQL)的恶化。此外，青春期的神经生物学和心理社会变化增加了对成瘾的易感性，使这些年轻人在手术后形成持续使用阿片类药物的风险增加。尽管研究表明心理因素在手术后持续疼痛和阿片类药物使用方面的重要性，但年轻人的标准围术期护理依赖阿片类药物治疗疼痛。非药物干预在这一人群中无法获得或广泛使用。我们自己的研究证明了mHealth心理社会干预在改善青年慢性疼痛相关结果方面的有效性。其他已发表的数据支持心理社会干预减少青少年手术后急性疼痛的有效性。利用利益相关者的意见，我们的团队在名为SurgeryPal的计划中调整了我们非常成功的技术交付的疼痛自我管理干预措施，用于围手术期。我们开发了两种截然不同的干预措施，在1)术前阶段针对心理社会危险因素，2)术后阶段传授疼痛自我管理技能。这项建议的目标是建立我们的mHealth围术期心理社会干预的有效性，以改善接受大型肌肉骨骼手术的青少年的临床有意义的结果，并确定干预的最佳提供时间。在UG3期间，我们的团队将与Hear ERN计划合作，计划在25个协作中心高效实施我们拟议的多站点随机临床试验，并为部署我们的干预措施做好准备。在UH3阶段，我们将对500名12-18岁接受脊柱融合手术的青年及其父母进行随机对照试验。除了标准的围手术期护理外，参与者还将使用析因设计在两个治疗阶段随机接受心理社会干预(SurgeryPal)或教育(注意力控制条件)，每个阶段为期4周(手术前和手术后)，以测试干预提供的时间。主要研究结果是术后前2周评估的急性疼痛严重程度和干预，以及3个月随访时的慢性疼痛强度和干预。次要结果包括HRQL、心理社会困扰、睡眠障碍以及阿片类药物的使用和误用。我们将研究心理社会干预在两个治疗阶段的协同作用，并探索预防从急性向CPSP过渡超过6个月的潜在治疗机制。该项目代表着在向接受大型肌肉骨骼手术的青年提供非药物治疗的创新方法方面取得的重大进展，这可能会影响临床实践的范式转变。这一干预措施有可能被整合到全国各地的儿科外科项目中，以减少CPSP的发生率和潜在的成瘾。

Acute and chronic postsurgical pain (CPSP) are a major health concern across the lifespan. Adolescents undergoing invasive musculoskeletal surgeries are particularly at risk, with 20% developing CPSP and associated deterioration in health-related quality of life (HRQL). Further, neurobiological and psychosocial changes during adolescence increase vulnerability to addiction, placing these youth at elevated risk for developing persistent opioid use following surgery. Despite research demonstrating the importance of psychological factors in persistence of pain and opioid use following surgery, standard perioperative care in youth relies on opioids to treat pain. Non-pharmacological interventions are not accessible or widely used in this population. Our own studies demonstrate efficacy of mHealth psychosocial interventions to improve chronic pain-related outcomes in youth. Other published data support efficacy of psychosocial interventions to reduce acute postsurgical pain in adolescents. Using stakeholder input, our team adapted our highly successful technology-delivered pain self-management intervention for the perioperative period in a program called SurgeryPal. We developed two distinct interventions to be delivered during 1) the pre-operative phase to target psychosocial risk factors, and 2) the post-operative phase to teach pain self-management skills. The goal of this proposal is to establish the effectiveness of our mHealth perioperative psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. During the UG3, our team will work cooperatively with the HEAL ERN Program to plan for the efficient implementation of our proposed multi-site randomized clinical trial at 25 collaborating centers and will ready our interventions for deployment. During the UH3 phase, we will conduct a randomized controlled trial in 500 youth age 12-18 years undergoing spinal fusion surgery and their parents. In addition to standard perioperative care, participants will be randomized using a factorial design to receive psychosocial intervention (SurgeryPal) or education (attention control condition) at two treatment phases, each of 4-weeks duration (pre-operative and post-operative) to test timing of intervention delivery. Primary study outcomes are acute pain severity and interference assessed over the first 2 weeks after surgery, and chronic pain intensity and interference at 3-month follow-up. Secondary outcomes include HRQL, psychosocial distress, sleep disturbance, and opioid use and misuse. We will examine synergy of psychosocial intervention during both treatment phases, and explore underlying treatment mechanisms of prevention of transition from acute to CPSP over 6 months. This project represents a significant advance in innovative approaches to deliver non-pharmacological therapies to youth undergoing major musculoskeletal surgeries, which may effect a paradigm shift in clinical practice. This intervention has potential to be integrated into pediatric surgery programs across the country to reduce incidence of CPSP and potential for addiction.