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

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ClinicalTrials.gov Identifier: NCT03238976
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Nature sounds Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Biopsy

Arm Intervention/treatment
Experimental: 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.

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

No Intervention: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238976


Contacts
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Contact: Sharon Harris 7737022777 sharris@radiology.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kirti Kulkarni, MD    773-702-1559    kirti.kulkarni@uchospitals.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Kirti Kulkarni, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03238976    
Other Study ID Numbers: IRB17-0355
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
breast core biopsy
core needle biopsies