Nature Sounds for Breast Cancer

Overseen By Cancer Clinical Trials Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether listening to nature sounds can reduce stress and improve comfort during a core needle biopsy (CNB), a common procedure for diagnosing breast cancer. Participants will either listen to nature sounds or receive standard care, which includes supportive dialogue. The researchers aim to determine if nature sounds offer a better experience during the procedure. This trial may suit individuals 21 years or older who are scheduled for a CNB and can communicate in English. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance patient comfort during medical procedures.

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

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

What prior data suggests that nature sounds exposure is safe for breast cancer patients during the CNB procedure?

Research has shown that listening to nature sounds during medical procedures can reduce anxiety and pain. Studies have found that similar therapies, such as music, calm patients during procedures like biopsies. This suggests that using nature sounds in a medical setting is generally safe and well-received. No specific side effects are linked to listening to nature sounds, making it a safe choice for patients. Overall, nature sounds provide a soothing experience during procedures without any known negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using nature sounds during breast cancer procedures because it provides a non-invasive way to potentially reduce patient anxiety and discomfort. Unlike the standard approach that uses supportive dialogue, nature sounds create a calming environment that might help patients feel more at ease during their core needle biopsy. This method taps into the soothing effects of natural soundscapes, which are thought to promote relaxation and stress relief, offering a unique and gentle alternative to traditional care methods.

What evidence suggests that nature sounds might be an effective treatment for breast cancer?

Research shows that listening to music, including nature sounds, can help reduce anxiety and pain during medical procedures like biopsies. One study found that music therapy lowered anxiety in patients undergoing breast biopsies. Although it didn't alter the procedure's results or pain levels, reducing anxiety can still improve the experience. In this trial, participants in the nature sounds group will hear continuous nature sounds during the core needle biopsy (CNB) procedure, potentially making the process less stressful for patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Kirti Kulkarni, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals aged 21 or older who are undergoing a breast core biopsy (CNB) and can read and speak English. Participants must provide written consent to join the study.

Inclusion Criteria

I am 21 years old or older.

Present for CNB

Provide written informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo a core needle biopsy (CNB) procedure with either nature sounds or supportive dialogue

30-45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Nature Sounds

Trial Overview

The study is testing if listening to nature sounds (NS) during CNB can help reduce pain and anxiety compared to standard care, which involves supportive dialogue. Patients will be randomly placed in either the NS group or the standard care group.

How Is the Trial Designed?

Group I: Nature sounds exposure Experimental Treatment 1 Intervention

Patients will be randomly assigned to either the nature sounds group or the standard care group. Patients in the nature sounds group will be exposed to continuous nature sounds during the core needle biopsy (CNB) procedure. The CNB procedure will continue as planned with nature sounds playing instead of the supportive dialogue. All sounds will be played out of a speaker situated in the corner of the room.

Group II: Standard care (supportive dialogue) Active Control 1 Intervention

Patients will be randomly assigned to either the nature sounds group or the standard care group. The CNB procedure will continue as planned with supportive dialogue which will be played out of a speaker situated in the corner of the room. This group follows the current standard of care.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a clinical trial involving 120 female breast cancer patients, music therapy significantly reduced state anxiety levels compared to routine nursing care alone, with lower anxiety scores observed at three different post-test measurements.

The study demonstrated that music therapy can be an effective complementary intervention for managing anxiety in patients following radical mastectomy, highlighting its potential role in holistic cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. Li, XM., Zhou, KN., Yan, H., et al.[2022]

In a randomized clinical trial involving breast cancer patients undergoing chemotherapy, a 30-minute music intervention before treatment significantly improved quality of life scores compared to a control group.

The music group also experienced lower levels of depression and anxiety, as well as reduced incidence of vomiting during chemotherapy, indicating that music can be an effective complementary therapy to alleviate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. Lima, TU., Moura, ECR., Oliveira, CMB., et al.[2021]

A review of 76 studies involving 92 cancer patients revealed that 87% of adverse events (AEs) from health food (HF) intake were due to the foods themselves, with 70% of identified cases being severe (grades 3 to 5).

Common severe AEs included hepatic and respiratory disorders, particularly in Japanese patients, and notable issues like hypercalcemia and bacterial infections were linked to specific health food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic Review of Case Reports on the Adverse Events Due to Health Food Intake by Cancer Patients]. Kojima, A., Sato, Y., Nishijima, C., et al.[2020]

Citations

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Ki67 scores were higher for core biopsy slides compared to paired whole sections from resections (p ≤ 0.001; median difference: 5.31%).

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pmc.ncbi.nlm.nih.gov

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The study suggests that cavitation as a physical mechanism can occur in operation of spring-loaded core needle biopsy devices in water and tissue-mimicking ...

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Imaging-Guided Core-Needle Breast Biopsy: Impact of ...

Results. The meditation and music groups reported significantly greater anxiety reduction (P values < .05) and reduced fatigue after biopsy than the standard- ...

8.

nature.com

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Diagnostic performance of deep learning in ultrasound ...

This systematic review of test diagnosis aims to examine the accuracy of DL, compared to human readers, for the diagnosis of breast cancer in the US under ...

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Needle core biopsy for breast lesions: An audit of 467 ...

This is a retrospective study analyzing the results of 467 patients who underwent needle core biopsy of breast imaging reporting and data system (BI-RADS) –3, ...