Breast CancerNCT03238976
Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy
A study testing Nature sounds in people with Breast Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nature sounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) ≥ 21 years old
- 2) present for CNB
- 3) to be able to read and speak English
- 4) provide written informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study
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.
Read the 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
- Being tested
- Nature sounds
- Keywords
- breast core biopsy, core needle biopsies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature soundsOther
Nature sounds will be played for patients in the nature sounds exposure group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the start of procedure until the end, not to exceed 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start11 Sep 2017
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirti Kulkarni, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238976
- Sponsor's protocol ID
- IRB17-0355
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2017
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study
- ClinicalTrials.gov ID
- NCT03238976
- Acronym / sponsor ID
- IRB17-0355
- Conditions
- Breast Cancer
- Keywords
- breast core biopsy, core needle biopsies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature sounds exposure | Experimental | Other: Nature soundsPatients 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) ≥ 21 years old
- 2) present for CNB
- 3) to be able to read and speak English
- 4) provide written informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature soundsNature sounds will be played for patients in the nature sounds exposure group. | Other | Nature sounds exposure |
Primary outcome
Measure of psychologic stress of patients and staff
Time frame: From the start of procedure until the end, not to exceed 2 years.
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.
Measure of physiologic stress of patients and staff
Time frame: From the start of procedure until the end, not to exceed 2 years.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirti Kulkarni, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature sounds in people with Breast Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of psychologic stress of patients and staff (time frame: From the start of procedure until the end, not to exceed 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.