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

73 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how immersive soundscapes might help manage pain, stress, and anxiety during outpatient vascular surgery. Researchers aim to determine if relaxing music and sounds can improve patients' heart rate and blood pressure compared to no music. It is ideal for English-speaking adults scheduled for venous ablation or port removal surgery who do not need an interpreter and can provide their own consent. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical experiences for future patients.

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 prior data suggests that immersive soundscapes are safe for surgery-related pain and anxiety management?

Research shows that listening to music or other immersive sounds can reduce pain and anxiety during medical procedures. Studies have found that music effectively lowers anxiety, pain, and physical signs like heart rate and blood pressure. Music interventions are generally safe and have very few side effects, making them a low-risk option for managing pain and stress during surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using immersive soundscapes for managing surgery-related pain and anxiety because they offer a non-drug alternative that could reduce reliance on medications like opioids, which have significant side effects and addiction risks. Unlike traditional pain management methods that involve pharmaceuticals, immersive soundscapes use relaxing music and sounds to create a calming environment, potentially easing patient anxiety and discomfort during procedures. This approach taps into the power of auditory stimulation to promote relaxation and well-being, offering a safer and potentially more pleasant experience for patients undergoing surgery.

What evidence suggests that immersive soundscapes are effective for managing surgery-related pain and anxiety?

Research has shown that listening to calming sounds can reduce pain and anxiety during medical procedures. In this trial, participants in the Immersive Soundscapes Environment arm will experience relaxing music and sounds during their procedure. One study found that music therapy, combined with regular pain relief methods, lowered pain and anxiety in emergency patients. Another study demonstrated that music effectively reduced pain, anxiety, blood pressure, and heart rate in post-surgery patients. Additionally, a review of various sound interventions, such as music and natural sounds, highlighted their positive effects on reducing stress in adults. These findings suggest that listening to relaxing sounds during surgery could make patients feel more comfortable and less anxious. ^{1 2 3 6 7}

Who Is on the Research Team?

Ellen Meltzer, MD, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am unable to understand or sign a consent form.

I need an English interpreter.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6175460/

Meta‐analysis evaluating music interventions for anxiety and ... This study aimed to evaluate anxiety and pain following perioperative music interventions compared with control conditions in adult patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962216013207

Utility of recorded guided imagery and relaxing music in ... Guided imagery and music can reportedly reduce pain and anxiety during surgery, but no comparative study has been performed for cutaneous surgery to our ...

3. intjem.biomedcentral.com intjem.biomedcentral.com/articles/10.1186/s12245-025-00878-4

The effect of music therapy on treating patients pain and ... In this study, we found that music therapy, when combined with standard analgesia, effectively reduced pain and anxiety in patients presenting to the ED.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9526790/

Effect of Music on Pain, Anxiety and Physiological ... Music was found to be effective on pain, anxiety, diastolic blood pressure, heart rate and oxygen saturation among post-operative sternotomy patients.

5. mental.jmir.org mental.jmir.org/2025/1/e69120

Effects of Sound Interventions on the Mental Stress Response ... This scoping review examines the effects of various sound interventions, including music, natural sounds, and speech, on the stress response in adults.

6. mhealth.jmir.org mhealth.jmir.org/2024/1/e48802

Technology-Based Music Interventions to Reduce Anxiety and ... Conclusions: Technology-based music interventions could help reduce anxiety and pain among patients undergoing surgery or procedures. The ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2023/03030/effect_on_music_therapy_on_quality_of_recovery_and.40.aspx

Effect on music therapy on quality of recovery and... While any analgesic regimen has potential side effects, music interventions have few side effects. This treatment is safe, inexpensive, simple, ...