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Improving Biopsy Experiences Study for Women

NCT01811043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2023-10-27

No results posted yet for this study

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.

Conditions

  • Imaging Guided Breast Biopsy

Interventions

BEHAVIORAL

Guided Meditation

BEHAVIORAL

Music

BEHAVIORAL

Supportive Dialogue

Sponsors & Collaborators

Principal Investigators

  • Mary Scott Soo, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811043 on ClinicalTrials.gov