Pilot study protocol for a novel perioperative mind-body intervention for peripheral vascular interventions
C Y Maximilian Png1, Gloria Y Yeh2,3, Anahita Dua1,4
1Division of Vascular Surgery, Department of Surgery, Massachusetts General Hospital, Boston.
Jvs-Vascular Insights
|March 26, 2025
Summary
A new mind-body intervention (MBI) will be tested in vascular surgery patients undergoing peripheral vascular interventions (PVIs) to assess its feasibility and patient experience.
Area of Science:
- Vascular Surgery
- Mind-Body Interventions
- Patient Outcomes
Background:
- A novel mind-body intervention (MBI) has been developed for patients undergoing peripheral vascular interventions (PVIs) under procedural sedation and analgesia (PSA).
- This intervention has not yet undergone clinical testing.
- An exploratory randomized controlled trial is planned to evaluate its efficacy.
Purpose of the Study:
- To test the feasibility and acceptability of a novel perioperative mind-body intervention (MBI).
- To evaluate the MBI's impact on patients undergoing peripheral vascular interventions (PVIs) under procedural sedation and analgesia (PSA).
Main Methods:
- An exploratory randomized controlled trial will enroll 30 patients undergoing PVIs under PSA across four hospitals.
- Participants will be randomized 1:1 to receive either the perioperative MBI or standard care.
- Data collection includes perioperative pain and sedation requirements, and qualitative feedback from patients and staff.
Main Results:
- This section is not applicable as the study is planned and results are not yet available.
Conclusions:
- This protocol outlines a pilot randomized controlled trial to assess the feasibility and acceptability of a novel perioperative MBI.
- The study aims to provide preliminary data on the MBI's potential benefits for patients undergoing PVIs under PSA.
Keywords:
Conscious sedationIntegrative medicineMAIAMind-body interventionPROMISPerioperative meditationSTAIVascular surgeryMore Related Videos
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