Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03877146
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Pain Pain, Acute Anxiety Coping Skills Self Efficacy Behavioral: Controlled Breathing Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Both conditions receive audio-recordings, and the radiologist care providers are blinded to the audio recordings participants receive.
Primary Purpose: Treatment
Official Title: Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 Outcome Measures :
  1. Number of pre-biopsy body pain sites: Body map [ Time Frame: Baseline ]
    To indicate the number of pre-biopsy body pain sites, participants will complete a full body map, indicating the locations of body pain.

  2. Number of pre-biopsy breast pain sites: Breast map [ Time Frame: Baseline ]
    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.

  3. Anticipated body pain: Anticipatory body pain scale [ Time Frame: Baseline ]
    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.

  4. Anticipated breast pain: Anticipatory breast pain scale [ Time Frame: Baseline ]
    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.

  5. Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline ]
    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).

  6. Likelihood of cancer pre-biopsy: Likelihood of cancer scale [ Time Frame: Baseline ]
    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.

  7. Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ) [ Time Frame: Baseline ]
    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.

  8. Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale [ Time Frame: Baseline ]
    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.

  9. Blood pressure pre-biopsy [ Time Frame: Baseline ]
    Blood pressure (systolic/diastolic) pre-biopsy will be measured using an MRI-compatible blood pressure cuff.

  10. Pulse pre-biopsy [ Time Frame: Baseline ]
    Heart rate pre-biopsy will be measured using an MRI-compatible pulse oximeter.

  11. Blood pressure after positioning on the MRI table [ Time Frame: After positioning on the MRI table, within 1 minute ]
    Blood pressure (systolic/diastolic) after positioning on the MRI table will be measured using an MRI-compatible blood pressure cuff.

  12. Pulse after positioning on the MRI table [ Time Frame: After positioning on the MRI table, within 1 minute ]
    Heart rate after positioning on the MRI table will be measured using an MRI-compatible pulse oximeter.

  13. Blood pressure after introducer insertion [ Time Frame: After last introducer insertion, within 1 minute ]
    Blood pressure (systolic/diastolic) after the last introducer is inserted will be measured using an MRI-compatible blood pressure cuff.

  14. Pulse after after introducer insertion [ Time Frame: After last introducer insertion, within 1 minute ]
    Heart rate after the last introducer is inserted will be measured using an MRI-compatible pulse oximeter.

  15. Blood pressure after introducer sheath removal [ Time Frame: After last introducer sheath removal, within 1 minute ]
    Blood pressure (systolic/diastolic) after the last introducer sheath is removed will be measured using an MRI-compatible blood pressure cuff.

  16. Pulse after introducer sheath removal [ Time Frame: After last introducer sheath removal, within 1 minute ]
    Heart rate after the last introducer sheath is removed will be measured using an MRI-compatible pulse oximeter.

  17. Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) [ Time Frame: Post-biopsy, within 1 hour ]
    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).

  18. Likelihood of cancer post-biopsy: Likelihood of cancer scale [ Time Frame: Post-biopsy, within 1 hour ]
    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).

  19. Distraction from pain during biopsy: Attention to pain scale [ Time Frame: Post-biopsy, within 1 hour ]
    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.

  20. Distraction from pain during biopsy: Time spent thinking about pain scale [ Time Frame: Post-biopsy, within 1 hour ]
    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).

  21. Relaxation during biopsy: Relaxation numerical rating scale (NRS) [ Time Frame: Post-biopsy, within 1 hour ]
    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).

  22. Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form [ Time Frame: Post-biopsy, within 1 hour ]
    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).

  23. Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ) [ Time Frame: Post-biopsy, within 1 hour ]
    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.

  24. Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale [ Time Frame: Post-biopsy, within 1 hour ]
    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.

  25. Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) [ Time Frame: 24 hours post-biopsy ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be women undergoing MRI-guided breast biopsies at the Duke Cancer Institute.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877146


Contacts
Layout table for location contacts
Contact: Alyssa N Van Denburg, M.A. 9194162347 alyssa.van.denburg@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Rebecca Shelby, Ph.D.    919-416-3410    rebecca.shelby@duke.edu   
Contact: Mary Scott Soo, M.D.    919-684-7829    mary.soo@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Rebecca Shelby, Ph.D. Duke Psychiatry and Behavioral Sciences

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03877146     History of Changes
Other Study ID Numbers: Pro00100029
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Controlled Breathing
MRI-Guided Breast Biopsy
Breast Pain
Body Pain
Anticipatory Pain
Anxiety
Coping Skills
Self Efficacy

Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Mastodynia
Pain
Neurologic Manifestations
Signs and Symptoms