Calming Alternatives Learned During MRI-Guided Breast Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2019-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Breast Pain Pain, Acute Anxiety Coping Skills Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Both conditions receive audio-recordings, and the radiologist care providers are blinded to the audio recordings participants receive.

Study Groups

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Usual Care Control Condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Controlled Breathing Intervention

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.

Group Type EXPERIMENTAL

Controlled Breathing Intervention

Intervention Type BEHAVIORAL

Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate).

Interventions

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Controlled Breathing Intervention

Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No