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

Duke University

Status: Completed

Conditions: Self Efficacy; Breast Cancer; Pain, Acute; Coping Skills; Anxiety; Breast Pain

Treatments: Behavioral: Controlled Breathing Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03877146

Pro00100029

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Usual Care Control Condition

No Intervention group

Description:

As part of usual care, participants will be provided with headphones to listen to music during the biopsy procedure. Music options will include instrumental jazz, classical piano, harp and flute, and world music.

Controlled Breathing Intervention

Experimental group

Description:

Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. Over the course of the 25-60-minute procedure, approximately 50% of the intervention will be spent completing controlled breathing. The other 50% of the intervention will be spent listening to music, which is part of usual care. Music options will include instrumental jazz, classical piano, harp and flute, nature sounds, and world music.

Treatment:

Behavioral: Controlled Breathing Intervention