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NCT01811043 · ClinicalTrials.gov registry record · NA
Improving Biopsy Experiences Study for Women
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 243
- Enrollment target
NCT01811043: Completed NA study, sponsored by Duke University.
NCT01811043 is a NA study that has completed, run by Duke University. The registered enrollment target is 243 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811043, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 243 participants
- Enrollment target
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.
Primary Outcome
Anxiety is measured using the State Anxiety Scale of the State Trait Anxiety Inventory. Women complete this self-report measure at baseline (i.e., immediately prior to biopsy in the biopsy clinic) and immediately post-biopsy. Change in anxiety will be measured as change from baseline to post biopsy (i.e., post biopsy anxiety - baseline anxiety.) The expected duration from baseline to post biopsy assessment is expected to be an average of 1.5 hours.
Interventions
- BEHAVIORAL Music
- BEHAVIORAL Guided Meditation
- BEHAVIORAL Supportive Dialogue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2012-08 |
| Est. Completion | 2017-02 |
| Phase | NA |
What the finished NCT01811043 record still lists
NCT01811043 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Music is the first listed.
NCT01811043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01811043 about?
NCT01811043 is a clinical study titled "Improving Biopsy Experiences Study for Women". 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...
What is the current status of trial NCT01811043?
This trial is currently completed. It is a NA study. The enrollment target is 243 participants. The study started on 2012-08. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01811043?
The interventions under investigation include: Music (BEHAVIORAL), Guided Meditation (BEHAVIORAL), Supportive Dialogue (BEHAVIORAL).
Who is sponsoring clinical trial NCT01811043?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01811043's enrollment target sits among peer trials
243 438th of 2000 higher than 1,562 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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