What side effects are associated with this type of intervention?

Common treatments for varicose veins include sclerotherapy, laser treatments, and vein stripping. Sclerotherapy can cause side effects such as swelling, skin discoloration, and bruising. Laser treatments may lead to skin burns, changes in skin color, and nerve damage. Vein stripping can result in pain, infection, and scarring. While the study on immersive soundscapes focuses on reducing stress and anxiety during vascular procedures, it does not directly address varicose vein treatments. However, managing stress and anxiety can be beneficial in improving overall patient experience during these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for varicose veins, including sclerotherapy, endovenous laser therapy (EVLT), and radiofrequency ablation (RFA). These treatments focus on closing or removing the affected veins to improve blood flow and reduce symptoms. While immersive soundscapes and auditory stimulation are being studied for their potential to reduce stress and anxiety during medical procedures, they are not directly related to the primary FDA-approved treatments for varicose veins. However, such non-pharmacological interventions could complement traditional treatments by improving patient comfort and reducing procedural anxiety.

What other types of research exist?

Promising alternatives to immersive soundscape for reducing stress and anxiety in varicose veins patients include Cognitive Behavioral Therapy for Insomnia (CBT-I), mindfulness-based interventions, guided imagery, and virtual follow-ups or telehealth options.

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Soundscapes for Surgery-Related Pain and Anxiety Management

N/A

Waitlist Available

Led By Ellen Meltzer, MD, MS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking adults

Be older than 18 years old

Must not have

Patients who lack the capacity to provide consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether playing calming sounds during outpatient vascular surgery can help reduce pain, stress, anxiety, heart rate, and blood pressure. Adult patients undergoing these procedures will either have the surgery with or without the immersive soundscape. The goal is to see if the soothing sounds make the experience more comfortable for patients. Music has been used historically for therapeutic purposes, including reducing stress and anxiety in various medical settings.

Who is the study for?

This trial is for English-speaking adults who are undergoing outpatient vascular surgery for varicose veins. It's not suitable for those who need an interpreter or can't consent.

What is being tested?

The study is testing whether immersive soundscapes can help reduce pain, stress, anxiety and improve heart rate and blood pressure during the procedure.

What are the potential side effects?

There may be no direct side effects from listening to soundscapes; however, individual reactions to audio stimulation vary and could include discomfort or increased anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult who speaks English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand or sign a consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Blood Pressure

Change in Heart Rate

Change in Self-Report Visual Analog Anxiety Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immersive Soundscapes EnvironmentExperimental Treatment1 Intervention

Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.

Group II: Control EnvironmentActive Control1 Intervention

Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have no music played during the procedure.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for varicose veins include sclerotherapy, laser therapy, and endovenous ablation. Sclerotherapy involves injecting a solution into the vein, causing it to scar and blood to reroute through healthier veins. Laser therapy uses light energy to close off varicose veins, while endovenous ablation employs heat to achieve the same effect. These treatments are crucial as they alleviate symptoms like pain and swelling, improve appearance, and prevent complications. Reducing stress and anxiety, as studied in immersive soundscape trials, can complement these treatments by improving overall patient well-being and potentially enhancing recovery outcomes.

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