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

NCT03238976 | Active Not Recruiting

• 1 other identifier: IRB17-0355
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomly assigned to one of two groups: the group exposed to NS, or the standard care group exposed to supportive dialogue. Patients assigned to the former group will be exposed to continuous NS throughout the CNB procedure.

Conditions

Breast Cancer

Keywords

breast core biopsy; core needle biopsies

Outcome Measures

Primary Outcomes (2)

• Measure of psychologic stress of patients and staff

  Patients and staff will be required to complete a questionnaire. Questions are organized so to capture levels of psychologic stress. The answers will be compared across the two groups and descriptive statistics will be calculated.

  From the start of procedure until the end, not to exceed 2 years.

• Measure of physiologic stress of patients and staff

  Parasympathetic activity will be measured by HF HRV in patients and staff. Descriptive statistics from these measurements will be calculated and compared across the two groups.

  From the start of procedure until the end, not to exceed 2 years.

Study Arms (2)

Nature sounds exposure

EXPERIMENTAL

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.

Other: Nature sounds

Standard care (supportive dialogue)

NO 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.

Interventions

Nature sounds OTHER

Nature sounds will be played for patients in the nature sounds exposure group.

Nature sounds exposure

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) ≥ 21 years old
• \) present for CNB
• \) to be able to read and speak English
• \) provide written informed consent.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kirti Kulkarni, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: September 11, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)