Clinical trial · Interventional
Calming Alternatives Learned During MRI-Guided Breast Biopsy
Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Pain | — | UNRESOLVED | — |
| Coping Skills | — | UNRESOLVED | — |
| Pain, Acute | — | UNRESOLVED | — |
| Self Efficacy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controlled Breathing Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care Control Condition
- 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.
- type
- EXPERIMENTAL
- label
- Controlled Breathing Intervention
- 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.
- interventionNames
- Behavioral: Controlled Breathing Intervention
Primary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available