Completed

IBESTImproving Biopsy Experiences Study for Women

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What is being tested

Guided Meditation

+ Music

+ Supportive Dialogue

Behavioral
Who is being recruted

Mental Disorders

+ Anxiety Disorders

Over 21 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorDuke University
Last updated: October 27, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01811043
Principal SponsorDuke University
Last updated: October 27, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

243 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAnxiety Disorders

Criteria

5 inclusion criteria required to participate
21 years old or older
Able to provide meaningful consent
Able to speak and read English
Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final assessment category 3,4a-c, or 5
Show More Criteria
1 exclusion criteria prevent from participating
significant hearing impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Guided meditation is played via headphones during biopsy

Group II

Active Comparator
Music is played via headphones during biopsy

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Cancer Institute

Durham, United StatesOpen Duke Cancer Institute in Google Maps
CompletedOne Study Center