Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Adherence to implementing a meditation program in the perioperative period
研究概览
简要总结
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
详细描述
This is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. Investigators will test the feasibility of implementing a meditation program in the perioperative period. Patients will be randomized to one of three groups: those who complete Isha Kriya (IK) meditation before and after surgery, those who complete postoperative IK meditation only, and those who receive the standard of care with no meditation intervention. In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. Blood will also be collected for analysis of biomarkers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Undergoing any of the following types of cardiac surgery: CABG with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery
- •Surgery scheduled for at least 14 days after enrollment
排除标准
- •Urgent and/or emergent surgery
- •Non-English speaking
- •Cognitive impairment as defined by total MoCA score < 10
- •Baseline DASS-21 depression score >10
- •Pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder
- •History of cerebrovascular accident or recent history (< 3 months) of seizures
- •History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
- •Current use of cognition enhancing drugs
- •Current management for chronic pain
- •Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
- •Educational attainment below high school level or equivalent
- •Significant visual impairment
结局指标
主要结局
Adherence to implementing a meditation program in the perioperative period
时间窗: Baseline through 1 month post surgery
In this descriptive, feasibility study, evaluation of feasibility will include adherence to meditation intervention (total number of sessions completed).
次要结局
- Cognitive function - MoCA(Baseline and hospital discharge (approximately 5 days))
- Total Opioid Consumption(Intraoperatively through 48 hours postoperatively)
- Changes in Sleep - PSQI(Baseline and 1 month postoperatively)
- Biomarkers of inflammation(Baseline, preoperatively, and Day 2 postoperatively)
- Pain scores(Postoperative Day 1 through hospital discharge (approximately 5 days))
- Changes in Sleep - PROMIS(Baseline through 1 month postoperatively)
研究者
Balachundhar Subramaniam
Principal Investigator
Beth Israel Deaconess Medical Center