Improving Biopsy Experiences Study for Women (IBEST)

Duke University

Status: Completed

Conditions: Imaging Guided Breast Biopsy

Treatments: Behavioral: Guided Meditation; Behavioral: Supportive Dialogue; Behavioral: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT01811043

Pro00038873

Details and patient eligibility

About

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.

Enrollment: 243 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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243 participants in 3 patient groups, including a placebo group

Guided Meditation

Experimental group

Description:

Guided meditation is played via headphones during biopsy

Treatment:

Behavioral: Guided Meditation

Music

Active Comparator group

Description:

Music is played via headphones during biopsy

Treatment:

Behavioral: Music

Supportive Dialogue

Placebo Comparator group

Description:

Supportive dialogue is provided during biopsy by the radiologist performing the procedure

Treatment:

Behavioral: Supportive Dialogue