Breast Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | 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: - |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. |
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