Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Feasibility of Implementing Preoperative Guided Meditation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.
Detailed Description
This is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. Patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.
Investigators
Anahita Dua, MBCHB, MBA, MSC
Associate Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Undergoing an endovascular procedure for peripheral vascular disease
- •Anesthesia plan for procedural sedation and analgesia
Exclusion Criteria
- •Pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder
- •Non-English speaking
- •Prior history of ipsilateral lower extremity amputation
- •Urgent or Emergent Surgery
- •Anesthesia plan for general anesthesia
- •Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
Outcomes
Primary Outcomes
Feasibility of Implementing Preoperative Guided Meditation
Time Frame: Immediately before surgery
Feasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation.
Secondary Outcomes
- Anxiety - STAI-6(Postoperative (within 6 hours after surgery))
- Interoceptive Attention - MAIA (Noticing Sub Scale)(Postoperative (within 6 hours after surgery))