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

Not Applicable

Completed

• Conditions: Peripheral Vascular Disease
• Interventions: Behavioral: Meditation

• Registration Number: NCT05837481
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-05-01
• Study Start: 2023-07-11
• Primary Completion: 2023-12-11
• Results First Submitted: 2024-02-07
• Study Completion: 2024-04-01
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Meditation Group	Meditation	Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery

Primary Outcome Measures

Name	Time	Method
Feasibility of Implementing Preoperative Guided Meditation	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 Outcome Measures

Name	Time	Method
Anxiety - STAI-6	Postoperative (within 6 hours after surgery)	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.
Interoceptive Attention - MAIA (Noticing Sub Scale)	Postoperative (within 6 hours after surgery)	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.

Trial Locations

Locations (4)

Salem Hospital; 🇺🇸 Salem, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Southern New Hampshire Hospital; 🇺🇸 Nashua, New Hampshire, United States