Pilot study protocol for a novel perioperative mind-body intervention for peripheral vascular interventions

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.