NCT03877146

Calming Alternatives Learned During MRI-Guided Breast Biopsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	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).

Timeline

• Start date: 2018-10-16
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2019-03-15
• Last updated: 2020-09-25

Locations

1 site across 1 country: United States