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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Behavioral: Meditation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Group<br>Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery | Behavioral: Meditation<br>* Guided meditation utilizing breath awareness, body scan and visualization techniques<br>|
| No Intervention: Control Group<br>Standard of care, which does not involve any meditation programs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and at the outpatient followup visit (approximately 1 month postoperatively). | 
| 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) | 
| 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) |