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

Massachusetts General Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peripheral Vascular Disease

Interventions

MeditationBEHAVIORAL

Guided meditation utilizing breath awareness, body scan and visualization techniques

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Newton Wellesley Hospital

Newton, Massachusetts, United States

Salem Hospital

Salem, Massachusetts, United States

Southern New Hampshire Hospital

Nashua, New Hampshire, United States

Outcomes

Primary Outcomes

Feasibility of Implementing Preoperative Guided Meditation

Feasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation.

Time frame: Immediately before surgery

Secondary Outcomes

Anxiety - STAI-6

The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse.

Time frame: Preoperative (prior to meditation)

Interoceptive Attention - MAIA (Noticing Sub Scale)

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. Higher scores indicate higher interoception, and thus are better. This sub scale score represented the combined scores of the 4 questions in the noticing sub scale, and ranged from 0 to 20.

Time frame: Preoperative (prior to meditation)

Anxiety - STAI-6

The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse.

Time frame: Postoperative (within 6 hours after surgery)

Interoceptive Attention - MAIA (Noticing Sub Scale)

Time frame: Postoperative (within 6 hours after surgery)

Data from ClinicalTrials.gov

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