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NCT03877146 · ClinicalTrials.gov registry record · NA
Calming Alternatives Learned During MRI-Guided Breast Biopsy
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT03877146: Completed NA study, sponsored by Duke University.
NCT03877146 is a NA study that has completed, run by Duke University. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03877146, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing a controlled breathing intervention during MRI-guided breast biopsy has the potential to provide effective pain management in this outpatient setting. The primary study objectives are to assess the feasibility, acceptability, and efficacy of a novel audio-recorded controlled breathing intervention for reducing breast and body pain in women undergoing MRI-guided breast biopsy. The secondary study objectives are to evaluate the effects of controlled breathing on measures of physiological reactivity (i.e., blood pressure and heart rate), pain catastrophizing, and self-efficacy for pain and anxiety.
Primary Outcome
Body pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the past week, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Interventions
- BEHAVIORAL Controlled Breathing Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2019-06-20 |
| Phase | NA |
What the finished NCT03877146 record still lists
NCT03877146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Controlled Breathing Intervention is the first listed.
NCT03877146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03877146 about?
NCT03877146 is a clinical study titled "Calming Alternatives Learned During MRI-Guided Breast Biopsy". The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing ...
What is the current status of trial NCT03877146?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2018-10-16. Estimated completion is 2019-06-20.
What interventions are being tested in trial NCT03877146?
The interventions under investigation include: Controlled Breathing Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03877146?
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 NCT03877146's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 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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