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

Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Behavioral: Meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Newton, Massachusetts, United States, 02462
      • Newton Wellesley Hospital
    • Salem, Massachusetts, United States, 01970
      • Salem Hospital
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Southern New Hampshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation Group; Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery	Behavioral: Meditation; Guided meditation utilizing breath awareness, body scan and visualization techniques
No Intervention: Control Group; Standard of care, which does not involve any meditation programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Postoperative (within 6 hours after surgery)
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.	Postoperative (within 6 hours after surgery)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Study Chair: Chien Yi M Png, MD, Massachusetts General Hospital; Study Director: Chien Yi M Png, MD, Massachusetts General Hospital; Principal Investigator: Anahita Dua, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2021P002072; F32HS028943-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No