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Spots Global Cancer Trial Database for Calming Alternatives Learned During MRI-Guided Breast Biopsy

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Trial Identification

Brief Title: Calming Alternatives Learned During MRI-Guided Breast Biopsy

Official Title: Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)

Study ID: NCT03877146

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Duke Cancer Institute, Durham, North Carolina, United States

Contact Details

Name: Rebecca Shelby, Ph.D.

Affiliation: Duke Psychiatry and Behavioral Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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