Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery

Mass General Brigham

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Behavioral: Meditation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05837481

2021P002072

F32HS028943-01 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Meditation Group

Experimental group

Description:

Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery

Treatment:

Behavioral: Meditation

Control Group

No Intervention group

Description:

Standard of care, which does not involve any meditation programs