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

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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.


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
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