Clinical trial NCT03877146: Calming Alternatives Learned During MRI-Guided Breast Biopsy
Official title: Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Pain
Pain, Acute
Anxiety
Coping Skills
Self Efficacy
Keywords: Controlled Breathing
MRI-Guided Breast Biopsy
Breast Pain
Body Pain
Anticipatory Pain
Anxiety
Coping Skills
Self Efficacy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: Baseline
measure: Breast pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: Baseline
measure: Body pain after positioning on the MRI table: Numerical rating scale (NRS)
timeFrame: After positioning on the MRI table, within 1 minute
measure: Breast pain after local anesthetic injection: Numerical rating scale (NRS)
timeFrame: After each superficial local anesthetic injection, within 1 minute
measure: Breast pain after deeper local anesthetic injection: Numerical rating scale (NRS)
timeFrame: After each deeper local anesthetic injection, within 1 minute
measure: Body pain after introducer insertion: Numerical rating scale (NRS)
timeFrame: After last introducer insertion, within 1 minute
measure: Breast pain after tissue sampling: Numerical rating scale (NRS)
timeFrame: After last tissue sampling at each biopsy site, within 1 minute
measure: Body pain after introducer sheath removal: Numerical rating scale (NRS)
timeFrame: After last introducer sheath removal, within 1 minute
measure: Body pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: Post-biopsy, within 1 minute
measure: Breast pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: Post-biopsy, within 1 minute
measure: Body pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: 24 hours post-biopsy
measure: Breast pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
timeFrame: 24 hours post-biopsy
Secondary outcomes:
measure: Number of pre-biopsy body pain sites: Body map
timeFrame: Baseline
measure: Number of pre-biopsy breast pain sites: Breast map
timeFrame: Baseline
measure: Anticipated body pain: Anticipatory body pain scale
timeFrame: Baseline
measure: Anticipated breast pain: Anticipatory breast pain scale
timeFrame: Baseline
measure: Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: Likelihood of cancer pre-biopsy: Likelihood of cancer scale
timeFrame: Baseline
measure: Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)
timeFrame: Baseline
measure: Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale
timeFrame: Baseline
measure: Blood pressure pre-biopsy
timeFrame: Baseline
measure: Pulse pre-biopsy
timeFrame: Baseline
measure: Blood pressure after positioning on the MRI table
timeFrame: After positioning on the MRI table, within 1 minute
measure: Pulse after positioning on the MRI table
timeFrame: After positioning on the MRI table, within 1 minute
measure: Blood pressure after introducer insertion
timeFrame: After last introducer insertion, within 1 minute
measure: Pulse after after introducer insertion
timeFrame: After last introducer insertion, within 1 minute
measure: Blood pressure after introducer sheath removal
timeFrame: After last introducer sheath removal, within 1 minute
measure: Pulse after introducer sheath removal
timeFrame: After last introducer sheath removal, within 1 minute
measure: Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
timeFrame: Post-biopsy, within 1 hour
measure: Likelihood of cancer post-biopsy: Likelihood of cancer scale
timeFrame: Post-biopsy, within 1 hour
measure: Distraction from pain during biopsy: Attention to pain scale
timeFrame: Post-biopsy, within 1 hour
measure: Distraction from pain during biopsy: Time spent thinking about pain scale
timeFrame: Post-biopsy, within 1 hour
measure: Relaxation during biopsy: Relaxation numerical rating scale (NRS)
timeFrame: Post-biopsy, within 1 hour
measure: Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form
timeFrame: Post-biopsy, within 1 hour
measure: Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)
timeFrame: Post-biopsy, within 1 hour
measure: Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale
timeFrame: Post-biopsy, within 1 hour
measure: Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
timeFrame: 24 hours post-biopsy
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke Psychiatry and Behavioral Sciences
name: Rebecca Shelby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: