Improving Biopsy Experiences Study for Women
This trial is active, not recruiting.
|Condition||imaging guided breast biopsy|
|Treatments||guided meditation, music, supportive dialogue|
|Start date||August 2012|
|End date||March 2014|
|Trial size||243 participants|
|Trial identifier||NCT01811043, Pro00038873|
The goal of this study is to examine whether a guided meditation intervention will reduce anxiety and distress as compared to a music intervention or radiologist supportive dialogue in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation and music interventions are administered through use of headphones during routine outpatient imaging-guided core needle breast biopsies. Women in the guided meditation and music conditions will be given a CD with instructions for home practice. Women complete follow-up questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is examined for 60 months.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
Change in Anxiety
time frame: Change in anxiety from baseline (i.e., pre biopsy) assessment to post biopsy assessment will be examined. Participants will be followed for the duration of the biopsy, with an expected average of 1.5 hours between assessments.
Rates of adherence to recommended follow-up care
time frame: 60 months following biopsy
Female participants at least 21 years old.
Inclusion Criteria: - 21 years old or older - Undergoing imaging guided core needle biopsy - Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final assessment category 3,4a-c, or 5 - Able to speak and read English - Able to provide meaningful consent Exclusion Criteria: - significant hearing impairment
|Official title||Improving Biopsy Experiences Study for Women|
|Principal investigator||Mary Scott Soo, MD|
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