Soundscapes for Surgery-Related Pain and Anxiety Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-English speakers, Lack capacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Immersive soundscapes for surgery-related pain and anxiety management?

Research shows that listening to music or therapeutic audio during surgery or recovery can help reduce pain and anxiety. For example, music therapy has been found to lower pain and anxiety in patients with nasal bone fractures and children undergoing major surgery, suggesting that immersive soundscapes might have similar benefits. ^{1 2 3 4 5}

Is immersive soundscape therapy safe for humans?

Research suggests that immersive soundscapes, like those used in virtual reality environments, are generally safe for humans. They have been used in various therapeutic settings, such as treating phobias, without reported safety concerns. ^{1 6 7 8 9}

How does the Soundscapes treatment for surgery-related pain and anxiety differ from other treatments?

The Soundscapes treatment is unique because it uses music or sound therapy to manage pain and anxiety, which is a non-drug approach. Unlike traditional pain management that often relies on medications, this treatment leverages the emotional and psychological effects of music to reduce pain perception and anxiety, potentially decreasing the need for pharmaceutical interventions. ^{1 2 3 10 11}

Research Team

Ellen Meltzer, MD, MS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am an adult who speaks English.

Exclusion Criteria

I am unable to understand or sign a consent form.

I need an English interpreter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo outpatient vascular surgery with or without immersive soundscapes

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain, stress, anxiety, heart rate, and blood pressure

1 week

Treatment Details

Interventions

• Immersive soundscapes

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

Participant Groups

Group I: Immersive Soundscapes Environment Experimental Treatment 1 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 Environment Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The study developed an auditory-visual interactive virtual reality environment specifically designed to treat cynophobia (fear of dogs), utilizing 3D sound to enhance the experience.

Testing with 10 participants revealed that the virtual environment effectively generated fear reactions, indicating its potential as a promising treatment tool for cynophobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory-visual virtual reality as a diagnostic and therapeutic tool for cynophobia. Suied, C., Drettakis, G., Warusfel, O., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Music Therapy for Pain and Anxiety Management in Nasal Bone Fracture Reduction: Randomized Controlled Clinical Trial. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Background Music's Impact on Patients Waiting in Surgery and Radiology Clinics. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Music and the PACU environment. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Developing and Selecting Auditory Warnings for a Real-Time Behavioral Intervention. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Auditory-visual virtual reality as a diagnostic and therapeutic tool for cynophobia. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of the Acoustic Environment in Hospital Wards on Patient Physiological and Psychological Indices. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Auditory-visual integration of emotional signals in a virtual environment for cynophobia. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability of a Smartphone-Based Music Intervention for Acute Pain. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. [2022]