Png C Y Maximilian, Yeh Gloria Y, Dua Anahita, Mohapatra Abhisekh, Malek Junaid Y, Zacharias Nikolaos, Balcom James H, Srivastava Sunita D, Eagleton Matthew J
Division of Vascular Surgery, Department of Surgery, Massachusetts General Hospital, Boston.
Osher Center for Integrative Health, Brigham and Women's Hospital, Boston.
JVS Vasc Insights. 2025;3:100199. doi: 10.1016/j.jvsvi.2025.100199. Epub 2025 Feb 6.
A novel mind-body intervention (MBI) targeting vascular surgery patients undergoing peripheral vascular interventions (PVIs) under procedural sedation and analgesia (PSA) was recently developed, but has yet to be clinically tested. An exploratory randomized controlled trial is planned to test the novel intervention in patients undergoing PVIs under PSA.
Patients undergoing PVIs under PSA by vascular surgeons across four hospitals in Massachusetts and New Hampshire will be screened for enrollment. Exclusion criteria include urgent or emergent procedures, prior ipsilateral lower extremity amputations (including digit amputations) and non-English speakers. 30 patients will be enrolled and randomized 1:1 to either a perioperative MBI on the day of surgery (n = 15), or a standard of care control (n = 15). There would be no restriction on anesthesia practice, and collected data will include perioperative pain and sedation requirements and qualitative feedback from both the patients and perioperative staff.
This protocol delineates a pilot randomized controlled trial to test the feasibility and acceptability of a novel perioperative MBI for patients undergoing PVIs under PSA.
最近开发了一种针对在程序镇静和镇痛（PSA）下接受外周血管介入治疗（PVI）的血管外科手术患者的新型身心干预（MBI），但尚未进行临床测试。计划开展一项探索性随机对照试验，以测试该新型干预措施对在PSA下接受PVI的患者的效果。
将对马萨诸塞州和新罕布什尔州四家医院的血管外科医生进行PSA下PVI治疗的患者进行筛选以纳入研究。排除标准包括紧急或急诊手术、既往同侧下肢截肢（包括手指截肢）以及非英语使用者。将招募30名患者并按1:1随机分为两组，一组在手术当天接受围手术期MBI（n = 15），另一组接受护理标准对照（n = 15）。麻醉方法不受限制，收集的数据将包括围手术期疼痛和镇静需求以及患者和围手术期工作人员的定性反馈。
本方案描述了一项试点随机对照试验，以测试一种新型围手术期MBI对在PSA下接受PVI的患者的可行性和可接受性。
