Martorella Geraldine, Hanley Adam W, Pickett Scott M, Gelinas Céline
Tallahassee Memorial Healthcare Center for Research and Evidence-Based Practice, College of Nursing, Florida State University, Tallahassee, FL, United States.
Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah, Salt Lake City, UT, United States.
JMIR Res Protoc. 2021 Aug 30;10(8):e30951. doi: 10.2196/30951.
Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.
The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.
A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.
Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.
This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30951.
心脏手术是一种常见的手术。然而，成人心脏手术后的疼痛可能会发展为慢性疼痛（持续超过3个月）。一旦出院，患者发生慢性术后疼痛（CPSP）和长期使用阿片类药物的风险更高，因为他们需要自我管理疼痛。心理风险和保护因素，如与疼痛相关的灾难性想法和疼痛接受度，决定了他们应对疼痛的能力以及阿片类药物的使用情况，这对疼痛的自我管理至关重要。基于正念的认知疗法（MBCT）的研究已经证明其对疼痛接受度和灾难性想法有潜在影响。然而，基于网络的MBCT预防CPSP的效果尚未得到研究。
本研究的目的是通过评估干预措施的可接受性或可行性，并研究其对术后6个月内疼痛强度、疼痛对活动的干扰、阿片类药物使用、疼痛接受度和灾难性想法的初步影响，对出院后的成年人进行为期4周的基于网络的MBCT干预进行试点测试。
将采用双盲试点随机对照试验来评估基于网络的MBCT干预措施。患者将根据以下标准进行选择：年龄≥18岁；首次通过正中胸骨切开术进行择期心脏手术；过去一周最严重疼痛评分≥4/10；有能力用英语理解并完成问卷；有能力使用智能手机、电脑或平板电脑等电子设备。在进行基线测量后，32名参与者将被随机分为两组：一组接受为期4周的简短基于网络的MBCT干预和常规护理（实验组），另一组仅接受一次标准化的基于网络的教育课程，并每周提醒和接受常规护理（注意力控制组）。2021年1月，佛罗里达州立大学研究与创造力委员会提供了同行评审的竞争性资金，佛罗里达州立大学机构审查委员会也批准了该研究的伦理审查。
招募工作于2021年6月开始。不幸的是，由于当前的COVID-19大流行，招募工作没有按预期进行。招募策略会根据有关大流行的最新数据和限制不断进行监测和更新。
这项研究具有重要意义，因为它针对CPSP的发展轨迹，CPSP是导致残疾和阿片类药物滥用的主要原因。这是第一项评估MBCT预防心脏手术后康复阶段CPSP的研究。这种方法具有创新性，因为它通过调节个体因素来促进疼痛的自我管理。如果成功，该干预措施可以扩展到众多有慢性疼痛风险的人群。
国际注册报告识别码（IRRID）：DERR1-10.2196/30951。
