Calming Alternatives Learned During MRI-Guided Breast Biopsy
Status: | Recruiting |
---|---|
Conditions: | Anxiety, Anxiety, Breast Cancer, Cancer |
Therapuetic Areas: | Oncology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | October 16, 2018 |
End Date: | June 6, 2019 |
Contact: | Alyssa N Van Denburg, M.A. |
Email: | alyssa.van.denburg@duke.edu |
Phone: | 9194162347 |
Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
Phone: 919-416-3410
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