Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.