Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Duke University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: Baseline
Body pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the past week, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: Baseline
Breast pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the past week, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Body pain after positioning on the MRI table: Numerical rating scale (NRS)
Time Frame: After positioning on the MRI table, within 1 minute
Body pain after positioning on the MRI table for the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after local anesthetic injection: Numerical rating scale (NRS)
Time Frame: After each superficial local anesthetic injection, within 1 minute
Breast pain after each superficial local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after deeper local anesthetic injection: Numerical rating scale (NRS)
Time Frame: After each deeper local anesthetic injection, within 1 minute
Breast pain after each deeper local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after tissue sampling: Numerical rating scale (NRS)
Time Frame: After last tissue sampling at each biopsy site, within 1 minute
Breast pain after the last tissue sampling at each biopsy site will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain after introducer insertion: Numerical rating scale (NRS)
Time Frame: After last introducer insertion, within 1 minute
Body pain after the last introducer is inserted will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain after introducer sheath removal: Numerical rating scale (NRS)
Time Frame: After last introducer sheath removal, within 1 minute
Body pain after the last introducer sheath is removed will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: Post-biopsy, within 1 minute
Body pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the biopsy procedure, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: Post-biopsy, within 1 minute
Breast pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the biopsy procedure, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Body pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: 24 hours post-biopsy
Body pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain in the 24 hours post-biopsy, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time Frame: 24 hours post-biopsy
Breast pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain in the 24 hours post-biopsy, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Secondary Outcomes
- Blood pressure after positioning on the MRI table(After positioning on the MRI table, within 1 minute)
- Blood pressure after introducer sheath removal(After last introducer sheath removal, within 1 minute)
- Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form(Post-biopsy, within 1 hour)
- Number of pre-biopsy body pain sites: Body map(Baseline)
- Likelihood of cancer pre-biopsy: Likelihood of cancer scale(Baseline)
- Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale(Baseline)
- Pulse pre-biopsy(Baseline)
- Pulse after positioning on the MRI table(After positioning on the MRI table, within 1 minute)
- Blood pressure after introducer insertion(After last introducer insertion, within 1 minute)
- Pulse after after introducer insertion(After last introducer insertion, within 1 minute)
- Number of pre-biopsy breast pain sites: Breast map(Baseline)
- Anticipated body pain: Anticipatory body pain scale(Baseline)
- Blood pressure pre-biopsy(Baseline)
- Anticipated breast pain: Anticipatory breast pain scale(Baseline)
- Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)(Baseline)
- Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)(Baseline)
- Likelihood of cancer post-biopsy: Likelihood of cancer scale(Post-biopsy, within 1 hour)
- Pulse after introducer sheath removal(After last introducer sheath removal, within 1 minute)
- Distraction from pain during biopsy: Attention to pain scale(Post-biopsy, within 1 hour)
- Distraction from pain during biopsy: Time spent thinking about pain scale(Post-biopsy, within 1 hour)
- Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)(Post-biopsy, within 1 hour)
- Relaxation during biopsy: Relaxation numerical rating scale (NRS)(Post-biopsy, within 1 hour)
- Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale(Post-biopsy, within 1 hour)
- Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)(24 hours post-biopsy)
- Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)(Post-biopsy, within 1 hour)