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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
First received
Last updated
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
Health authority
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)

Study Design


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)
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