Packiasabapathy Senthil, Susheela Ammu T, Mueller Ariel, Patxot Melissa, Gasangwa Doris-Vanessa, O'Gara Brian, Shaefi Shahzad, Marcantonio Edward R, Yeh Gloria Y, Subramaniam Balachundhar
Department of Anesthesia, Critical Care and Pain Medicine, Indiana University School of Medicine, 340 W 10th St #6200, Indianapolis, IN, 46202, USA.
Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA, 02215, USA.
Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.
Cardiac surgical procedures are associated with postoperative neurological complications such as cognitive decline and delirium, which can complicate recovery and impair quality of life. Perioperative depression and anxiety may be associated with increased mortality after cardiac surgeries. Surgical prehabilitation is an emerging concept that includes preoperative interventions to potentially reduce postoperative complications. While most current prehabilitation interventions focus on optimizing physical health, mind-body interventions are an area of growing interest. Preoperative mind-body interventions such as Isha Kriya meditation, may hold significant potential to improve postsurgical outcomes.
This is a prospective, randomized controlled feasibility trial. A total of 40 adult patients undergoing cardiac surgery will be randomized to one of three study groups. Participants randomized to either of the two intervention groups will receive meditative intervention: (1) commencing two weeks before surgery; or (2) commencing only from the day after surgery. Meditative intervention will last for four weeks after the surgery in these groups. Participants in the third control group will receive the current standard of care with no meditative intervention. All participants will undergo assessments using neurocognitive, sleep, depression, anxiety, and pain questionnaires at various time points in the perioperative period. Blood samples will be collected at baseline, preoperatively, and postoperatively to assess for inflammatory biomarkers. The primary aim of this trial is to assess the feasibility of implementing a perioperative meditative intervention program. Other objectives include studying the effect of meditation on postoperative pain, sleep, psychological wellbeing, cognitive function, and delirium. These will be used to calculate effect size to design future studies.
This study serves as the first step towards understanding the feasibility of implementing a mind-body intervention as a prehabilitative intervention to improve postoperative surgical outcomes after cardiac surgery.
Clinicaltrials.gov, NCT03198039 . Registered on 23 June 2017.
心脏外科手术与术后神经并发症相关，如认知功能下降和谵妄，这会使恢复过程复杂化并损害生活质量。围手术期的抑郁和焦虑可能与心脏手术后死亡率增加有关。手术预康复是一个新兴概念，包括术前干预措施，以潜在地减少术后并发症。虽然目前大多数预康复干预措施侧重于优化身体健康，但身心干预是一个越来越受关注的领域。术前身心干预，如伊沙克里亚冥想，可能具有显著潜力来改善术后结果。
这是一项前瞻性、随机对照可行性试验。共有40名接受心脏手术的成年患者将被随机分配到三个研究组之一。随机分配到两个干预组之一的参与者将接受冥想干预：（1）手术前两周开始；或（2）仅从手术后第一天开始。在这些组中，冥想干预将在手术后持续四周。第三对照组的参与者将接受当前的标准护理，不进行冥想干预。所有参与者将在围手术期的不同时间点使用神经认知、睡眠、抑郁、焦虑和疼痛问卷进行评估。将在基线、术前和术后采集血样以评估炎症生物标志物。本试验的主要目的是评估实施围手术期冥想干预计划的可行性。其他目标包括研究冥想对术后疼痛、睡眠、心理健康、认知功能和谵妄的影响。这些将用于计算效应大小，以设计未来的研究。
本研究是了解将身心干预作为预康复干预措施以改善心脏手术后术后手术结果的可行性的第一步。
Clinicaltrials.gov，NCT03198039。于2017年6月23日注册。
