Overview

This trial is active, not recruiting.

Condition imaging guided breast biopsy
Treatments guided meditation, music, supportive dialogue
Sponsor Duke University
Start date August 2012
End date March 2014
Trial size 243 participants
Trial identifier NCT01811043, Pro00038873

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Guided meditation is played via headphones during biopsy
guided meditation
(Active Comparator)
Music is played via headphones during biopsy
music
(Placebo Comparator)
Supportive dialogue is provided during biopsy by the radiologist performing the procedure
supportive dialogue

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Rates of adherence to recommended follow-up care
time frame: 60 months following biopsy

Eligibility Criteria

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

Additional Information

Official title Improving Biopsy Experiences Study for Women
Principal investigator Mary Scott Soo, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Duke University.