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

Peripheral Vascular Disease Clinical Trial

Official title:

Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05837481
• Other study ID #: 2021P002072
• Secondary ID: F32HS028943-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Behavioral:
• Meditation
Guided meditation utilizing breath awareness, body scan and visualization techniques

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southern New Hampshire Hospital	Nashua	New Hampshire
United States	Newton Wellesley Hospital	Newton	Massachusetts
United States	Salem Hospital	Salem	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life - PROMIS-10 Global health.	The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health survey is a patient-reported measure of health-related quality of life. The score range for the PROMIS-10 is from 0 to 20. Higher scores indicate higher quality of life, and thus are better.	Baseline
Secondary	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) and Postoperative (within 6 hours after surgery)
Secondary	Interoceptive attention - MAIA (Noticing sub scale)	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. The score range of the MAIA is from 0 to 5. Higher scores indicate higher awareness, and thus are better.	Preoperative (prior to meditation) and Postoperative (within 6 hours after surgery)