Calming Alternatives Learned During MRI-Guided Breast Biopsy

Not Applicable

Completed

• Conditions: Breast Cancer; Pain, Acute; Coping Skills; Self Efficacy; Breast Pain; Anxiety
• Interventions: Behavioral: Controlled Breathing Intervention

• Registration Number: NCT03877146
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Status Verified: 2018-11
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controlled Breathing Intervention	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.

Primary Outcome Measures

Name	Time	Method
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale	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	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)	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)	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)	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)	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)	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)	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	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	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	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	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

Name	Time	Method
Blood pressure after positioning on the MRI table	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.
Blood pressure after introducer sheath removal	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.
Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form	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).
Number of pre-biopsy body pain sites: Body map	Baseline	To indicate the number of pre-biopsy body pain sites, participants will complete a full body map, indicating the locations of body pain.
Likelihood of cancer pre-biopsy: Likelihood of cancer scale	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.
Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale	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.
Pulse pre-biopsy	Baseline	Heart rate pre-biopsy will be measured using an MRI-compatible pulse oximeter.
Pulse after positioning on the MRI table	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.
Blood pressure after introducer insertion	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.
Pulse after after introducer insertion	After last introducer insertion, within 1 minute	Heart rate after the last introducer is inserted will be measured using an MRI-compatible pulse oximeter.
Number of pre-biopsy breast pain sites: Breast map	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.
Anticipated body pain: Anticipatory body pain scale	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.
Blood pressure pre-biopsy	Baseline	Blood pressure (systolic/diastolic) pre-biopsy will be measured using an MRI-compatible blood pressure cuff.
Anticipated breast pain: Anticipatory breast pain scale	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.
Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	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).
Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)	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.
Likelihood of cancer post-biopsy: Likelihood of cancer scale	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).
Pulse after introducer sheath removal	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.
Distraction from pain during biopsy: Attention to pain scale	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.
Distraction from pain during biopsy: Time spent thinking about pain scale	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).
Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	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).
Relaxation during biopsy: Relaxation numerical rating scale (NRS)	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).
Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale	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.
Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)	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).
Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)	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.

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States