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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Anxiety; Pain, Acute; Self Efficacy; Coping Skills; Breast Pain
• Intervention / Treatment: Behavioral: Controlled Breathing Intervention

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	Baseline
Breast pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	Baseline
Body pain after positioning on the MRI table: Numerical rating scale (NRS)	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.	After positioning on the MRI table, within 1 minute
Breast pain after local anesthetic injection: Numerical rating scale (NRS)	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.	After each superficial local anesthetic injection, within 1 minute
Breast pain after deeper local anesthetic injection: Numerical rating scale (NRS)	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.	After each deeper local anesthetic injection, within 1 minute
Body pain after introducer insertion: Numerical rating scale (NRS)	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.	After last introducer insertion, within 1 minute
Breast pain after tissue sampling: Numerical rating scale (NRS)	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.	After last tissue sampling at each biopsy site, within 1 minute
Body pain after introducer sheath removal: Numerical rating scale (NRS)	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.	After last introducer sheath removal, within 1 minute
Body pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	Post-biopsy, within 1 minute
Breast pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	Post-biopsy, within 1 minute
Body pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	24 hours post-biopsy
Breast pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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.	24 hours post-biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pre-biopsy body pain sites: Body map	To indicate the number of pre-biopsy body pain sites, participants will complete a full body map, indicating the locations of body pain.	Baseline
Number of pre-biopsy breast pain sites: Breast map	To indicate the number of pre-biopsy breast pain sites, participants will complete a breast map (showing the chest, shoulders, and upper arms), indicating the locations of breast pain.	Baseline
Anticipated body pain: Anticipatory body pain scale	Prior to biopsy, one question will be asked to assess anticipated body pain (i.e., "How much body pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.	Baseline
Anticipated breast pain: Anticipatory breast pain scale	Prior to biopsy, one question will be asked to assess anticipated breast pain (i.e., "How much breast pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.	Baseline
Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety pre-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).	Baseline
Likelihood of cancer pre-biopsy: Likelihood of cancer scale	Likelihood of cancer will be assessed pre-biopsy using a 1 single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from their recommending radiologist on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer) with higher scores indicating a greater likelihood of cancer.	Baseline
Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)	To assess the use of pain coping strategies pre-biopsy, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they use seven pain coping strategies (two items per scale) on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.	Baseline
Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale	To assess self-efficacy for managing pain and anxiety pre-biopsy, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 1 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.	Baseline
Blood pressure pre-biopsy	Blood pressure (systolic/diastolic) pre-biopsy will be measured using an MRI-compatible blood pressure cuff.	Baseline
Pulse pre-biopsy	Heart rate pre-biopsy will be measured using an MRI-compatible pulse oximeter.	Baseline
Blood pressure after positioning on the MRI table	Blood pressure (systolic/diastolic) after positioning on the MRI table will be measured using an MRI-compatible blood pressure cuff.	After positioning on the MRI table, within 1 minute
Pulse after positioning on the MRI table	Heart rate after positioning on the MRI table will be measured using an MRI-compatible pulse oximeter.	After positioning on the MRI table, within 1 minute
Blood pressure after introducer insertion	Blood pressure (systolic/diastolic) after the last introducer is inserted will be measured using an MRI-compatible blood pressure cuff.	After last introducer insertion, within 1 minute
Pulse after after introducer insertion	Heart rate after the last introducer is inserted will be measured using an MRI-compatible pulse oximeter.	After last introducer insertion, within 1 minute
Blood pressure after introducer sheath removal	Blood pressure (systolic/diastolic) after the last introducer sheath is removed will be measured using an MRI-compatible blood pressure cuff.	After last introducer sheath removal, within 1 minute
Pulse after introducer sheath removal	Heart rate after the last introducer sheath is removed will be measured using an MRI-compatible pulse oximeter.	After last introducer sheath removal, within 1 minute
Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).	Post-biopsy, within 1 hour
Likelihood of cancer post-biopsy: Likelihood of cancer scale	Likelihood of cancer will be assessed post-biopsy using a single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from the radiologist performing the biopsy on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer).	Post-biopsy, within 1 hour
Distraction from pain during biopsy: Attention to pain scale	Using a 2-item self-report measure, participants will rate 1) the amount of attention they paid to the pain during biopsy and 2) the extent to which they were able to distract themselves from the pain during biopsy on an 11-point scale, ranging from 0 (not at all) to 10 (very much). An ''attention to pain" score (range -10 to +10) will be calculated by subtracting the ability to distract from pain from the amount of attention to pain. The higher the score, the more attention paid to pain.	Post-biopsy, within 1 hour
Distraction from pain during biopsy: Time spent thinking about pain scale	Participants will also be asked to rate how much time they spent thinking about pain during the biopsy procedure on an 11-point scale, ranging from 0 (none of the time) to 10 (all of the time).	Post-biopsy, within 1 hour
Relaxation during biopsy: Relaxation numerical rating scale (NRS)	Participants will be asked to indicate how relaxed they were during the biopsy procedure on a scale, ranging from 0 (not relaxed) to 10 (extremely relaxed).	Post-biopsy, within 1 hour
Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form	Participants will also be provided with a list of six adjectives (i.e., tense, on-edge, uneasy, restless, nervous, and anxious) from the Tension Subscale of the Profile of Mood State Short-Form and be asked to rate each of the adjectives on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely).	Post-biopsy, within 1 hour
Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)	To assess the use of pain coping strategies during the biopsy procedure, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they used seven pain coping strategies (two items per scale) during the procedure on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.	Post-biopsy, within 1 hour
Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale	To assess self-efficacy for managing pain and anxiety during the biopsy procedure, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 0 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.	Post-biopsy, within 1 hour
Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety 24 hours post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).	24 hours post-biopsy

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rebecca Shelby, Ph.D., Duke Psychiatry and Behavioral Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2018
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): June 20, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (ACTUAL): March 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Anxiety; Coping Skills; Self Efficacy; Breast Pain; Body Pain; Controlled Breathing; MRI-Guided Breast Biopsy; Anticipatory Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Mastodynia
• Other Study ID Numbers: Pro00100029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No