Calming Alternatives Learned During MRI-Guided Breast Biopsy

NCT03877146 | Completed

• 1 other identifier: Pro00100029
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (25)

• Number of pre-biopsy body pain sites: Body map

  Baseline

• Number of pre-biopsy breast pain sites: Breast map

  Baseline

• Anticipated body pain: Anticipatory body pain scale

  Baseline

• Anticipated breast pain: Anticipatory breast pain scale

  Baseline

• Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)

  Baseline

Study Arms (2)

Usual Care Control Condition

NO INTERVENTION

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.

Controlled Breathing Intervention

EXPERIMENTAL

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

Interventions

Controlled Breathing Intervention BEHAVIORAL

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).

Controlled Breathing Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be women undergoing MRI-guided breast biopsies at the Duke Cancer Institute.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Mastodynia; Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rebecca Shelby, Ph.D.

  Duke Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Both conditions receive audio-recordings, and the radiologist care providers are blinded to the audio recordings participants receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 15, 2019
• Study Start: October 16, 2018
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: September 25, 2020

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)