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Nature Sounds for Breast Cancer

N/A

Waitlist Available

Led By Kirti Kulkarni, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

≥ 21 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of procedure until the end, not to exceed 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not continuous exposure to non-verbal support (NS) during a chemotherapy-induced nausea and vomiting (CINV) procedure helps to reduce the severity of symptoms experienced. Patients will be randomly assigned to either the NS group or a control group who will receive standard care (supportive dialogue).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves listening to nature sounds, there are no direct medical side effects expected. However, individual reactions to sound therapy may vary.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of procedure until the end, not to exceed 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of procedure until the end, not to exceed 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of procedure until the end, not to exceed 2 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Measure of physiologic stress of patients and staff

Measure of psychologic stress of patients and staff

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: Nature sounds exposureExperimental Treatment1 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 Control1 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.

0 / 1Eligibility criteria met