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

NCT ID: NCT03238976

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2025-12-31

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.

Detailed Description

For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient positioning and breast compression is complete, (2) One 2-min local anesthesia administration period during which the skin is injected with local anesthetic and an incision is made to insert the biopsy needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia administration period during which imaging is obtained to confirm the position of the needle with respect to the target, (4) One 1-minute sampling period when the breast tissue is sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained samples is confirmed and the need for additional sampling determined, and (6) One 2-minute period during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.

For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient is positioning, (2) One 2-min local anesthesia administration period during which local anesthesia is given at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local anesthesia administration period during which intra-procedure imaging and confirmation of adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during which the biopsy device is advanced to the target for the first time and fired to acquire the first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6) One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.

The total time for a single site CNB is approximately 30 minutes when performed under US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added physiological recordings for this experiment are not expected to significantly prolong the duration of CNB procedures.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nature sounds exposure

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 Type: EXPERIMENTAL

Nature sounds

Intervention Type: OTHER

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

Standard care (supportive dialogue)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nature sounds

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1) ≥ 21 years old
• 2) present for CNB
• 3) to be able to read and speak English
• 4) provide written informed consent.

Exclusion Criteria

-

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirti Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB17-0355

Identifier Type: -

Identifier Source: org_study_id