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Guided Meditation for Surgery-related Anxiety

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Undergoing an endovascular procedure for peripheral vascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before surgery
Awards & highlights

Study Summary

This trial will test if meditation can help ease pain & anxiety for people having surgeries that involve sedation and pain relief.

Who is the study for?
This trial is for adults over 18 who are scheduled for a non-emergency endovascular procedure to treat peripheral vascular disease, using sedation and pain relief. It's not open to those with psychiatric disorders, non-English speakers, amputees, or patients needing general anesthesia or combined surgeries.Check my eligibility
What is being tested?
The study is exploring the effectiveness of guided meditation in reducing anxiety and improving cooperation during surgery among patients receiving local sedation for vascular interventions.See study design
What are the potential side effects?
Since this trial involves guided meditation as an intervention, there are no direct medical side effects expected. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am having a procedure for blood vessel issues in my legs or arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative (prior to meditation) and postoperative (within 6 hours after surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative (prior to meditation) and postoperative (within 6 hours after surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of implementing preoperative guided meditation
Secondary outcome measures
Anxiety - STAI-6
Interoceptive attention - MAIA (Noticing sub scale)
Quality of Life - PROMIS-10 Global health.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Meditation GroupExperimental Treatment1 Intervention
Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery
Group II: Control GroupActive Control1 Intervention
Standard of care, which does not involve any meditation programs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meditation
2021
Completed Phase 3
~2740

Find a Location

Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED
401 Previous Clinical Trials
6,821,732 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,919 Total Patients Enrolled

Media Library

Guided Meditation Clinical Trial Eligibility Overview. Trial Name: NCT05837481 — N/A
Peripheral Vascular Disease Research Study Groups: Meditation Group, Control Group
Peripheral Vascular Disease Clinical Trial 2023: Guided Meditation Highlights & Side Effects. Trial Name: NCT05837481 — N/A
Guided Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837481 — N/A
~16 spots leftby Jun 2025
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