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Brief Title: Calming Alternatives Learned During MRI-Guided Breast Biopsy
Official Title: Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
Study ID: NCT03877146
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Duke Cancer Institute, Durham, North Carolina, United States
Name: Rebecca Shelby, Ph.D.
Affiliation: Duke Psychiatry and Behavioral Sciences
Role: PRINCIPAL_INVESTIGATOR