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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.

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I am having a procedure for blood vessel issues in my legs or arms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative (prior to meditation) and postoperative (within 6 hours after surgery)

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,318 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,611 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are opportunities available for participants to join this medical research?

"According to the data from clinicaltrials.gov, this medical trial is in need of volunteers and was initially posted on July 11th 2023 with a recent edit made on July 18th 2023."

Answered by AI

How many facilities are offering this research study?

"Presently, 4 trial sites are enrolling patients; 2 of which reside in Newton and Salem with the last two being located near Nashua. It is suggested that you select a nearby location to reduce transportation needs if chosen for participation."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative, clinicaltrials.gov demonstrates that this trial is recruiting participants; it was initially published on July 11th 2023 and recently revised on the 18th of July 2023. Altogether, 50 patients are required from 4 medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anahita Dua, MBCHB, MBA, MSC 2023. "Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837481.