Breast Cancer Clinical Trial

Calming Alternatives Learned During MRI-Guided Breast Biopsy

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

58

Study ID:

NCT03877146

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke Cancer Institute
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

58

Study ID:

NCT03877146

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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