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Nature Sounds for Breast Cancer

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure of physiologic stress of patients and staff

Measure of psychologic stress of patients and staff

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

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,591 Total Patients Enrolled

25 Trials studying Breast Cancer

4,559 Patients Enrolled for Breast Cancer

Kirti Kulkarni, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Nature sounds Clinical Trial Eligibility Overview. Trial Name: NCT03238976 — N/A

Breast Cancer Research Study Groups: Nature sounds exposure, Standard care (supportive dialogue)

Breast Cancer Clinical Trial 2023: Nature sounds Highlights & Side Effects. Trial Name: NCT03238976 — N/A

Nature sounds 2023 Treatment Timeline for Medical Study. Trial Name: NCT03238976 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this experiment?

"Correct. According to clinicaltrials.gov, this medical study is still welcoming participants since it was first published on September 11th 2017 with the most recent edit made being January 7th 2022. 200 individuals are needed from 1 site in order to participate in the trial."

Answered by AI

Are there still unfilled positions for this research project?

"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, which was first announced on the 11th of September 2017, is currently accepting candidates for participation. 200 subjects need to be recruited from one single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy

2017. "Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03238976.

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