Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03877146
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2019-02-26
Brief Title:
Calming Alternatives Learned During MRI-Guided Breast Biopsy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Calming Alternatives Learned During MRI-Guided Breast Biopsy CALM
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
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 ie blood pressure and heart rate pain catastrophizing and self-efficacy for pain and anxiety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None