Calming Alternatives Learned During MRI-Guided Breast Biopsy
Completed · Not applicable
Conditions studied: Breast Cancer, Breast Pain, Pain, Acute, Anxiety, Coping Skills, Self Efficacy
In brief
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.
Key facts
- Study ID
- NCT03877146
- Run by
- Duke University
- People needed
- 58
- Starts
- 2018-10-16
- Expected to finish
- 2019-06-20
- Last updated by the study team
- 2020-09-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women undergoing MRI-guided core needle breast biopsy at the Duke Cancer Institute
- Ability to speak and read in English
- Age ≥ 18 years
- Ability to provide meaningful consent
You may not qualify if…
- Hearing impairment that is documented in the medical record that would limit the use of the guided intervention or music
- Cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent
- Undergoing IV-administered sedation
Where it is running
- Duke Cancer Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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