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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05837481

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Behavioral: Meditation	N/A

Detailed Description

This is a prospective, randomized, controlled study involving 50 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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Quality of Life - PROMIS-10 Global health. [Baseline and at the outpatient followup visit (approximately 1 month postoperatively).]
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.
Anxiety - STAI-6 [Preoperative (prior to meditation) and 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, Attention-Regulation and Self-Regulation sub scales) [Preoperative (prior to meditation) and Postoperative (within 6 hours after surgery)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
Undergoing an endovascular procedure for a peripheral arterial disease indication (claudication or chronic limb threatening ischemia)
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 lower extremity amputation
Urgent or Emergent Surgery
Anesthesia plan for general anesthesia
Undergoing a hybrid procedure (simultaneous endovascular and open surgery)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anahita Dua, MBCHB, MBA, MSC, Associate Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05837481

Other Study ID Numbers:

2021P002072
F32HS028943-01

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of May 1, 2023