Back to resultsGuided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
Primary Purpose
Peripheral Vascular Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease
Eligibility Criteria
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 lower extremity amputation Urgent or Emergent Surgery Anesthesia plan for general anesthesia Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
Sites / Locations
- Massachusetts General HospitalRecruiting
- Newton Wellesley HospitalRecruiting
- Salem HospitalRecruiting
- Southern New Hampshire HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Meditation Group
Control Group
Arm Description
Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery
Standard of care, which does not involve any meditation programs
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05837481
First Posted
April 6, 2023
Last Updated
July 18, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT05837481
Brief Title
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
Official Title
Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meditation Group
Arm Type
Experimental
Arm Description
Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard of care, which does not involve any meditation programs
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
Guided meditation utilizing breath awareness, body scan and visualization techniques
Primary Outcome Measure Information:
Title
Feasibility of implementing preoperative guided meditation
Description
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 Outcome Measure Information:
Title
Quality of Life - PROMIS-10 Global health.
Description
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.
Time Frame
Baseline and at the outpatient followup visit (approximately 1 month postoperatively).
Title
Anxiety - STAI-6
Description
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) and Postoperative (within 6 hours after surgery)
Title
Interoceptive attention - MAIA (Noticing sub scale)
Description
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.
Time Frame
Preoperative (prior to meditation) and Postoperative (within 6 hours after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 lower extremity amputation
Urgent or Emergent Surgery
Anesthesia plan for general anesthesia
Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien Yi M Png, MD
Phone
617-726-5308
Email
cypng@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anahita Dua, MD
Phone
617-726-5308
Email
adua1@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien Yi M Png, MD
Phone
617-726-2000
Email
cypng@mgh.harvard.edu
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abe Mohapatra, MD
Facility Name
Salem Hospital
City
Salem
State/Province
Massachusetts
ZIP/Postal Code
01970
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junaid Malek, MD
Facility Name
Southern New Hampshire Hospital
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien Yi M Png, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
We'll reach out to this number within 24 hrs