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Breastfeeding Self-Management for Nipple and Breast Pain (BSM)

Primary Purpose

Breastfeeding, Breast Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-monitoring of BF and intervention
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding focused on measuring Breast and Nipple Pain, Quantitative Sensory Testing, Genotyping, Breastfeeding

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Have just given birth (<48 hours)
  • Intention to breastfeed for 6 weeks
  • Has daily access to a computer with internet
  • Access to a phone
  • Read and speak English
  • Delivered a healthy singleton infant born >37 weeks gestational age

Exclusion Criteria:

  • Infants with congenital anomalies
  • Mothers with major mental health issues (i.e Schizophrenia, Mania, Bipolar Disorder)
  • Complications during delivery requiring intervention
  • Mothers with major health issues that are not associated with pregnancy as determined by principal investigator (i.e. infection illness such as HIV+, hepatitis, diabetes, history of seizures, current diagnosis of cancer).

Sites / Locations

  • UConn Health
  • Manchester Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-monitoring of BF and intervention

Control

Arm Description

Self-monitoring and regulation skills will be provided to mothers at discharge. Aside from daily diaries outlining, infant feeding behaviors and pain, mothers will be instructed to watch several 5-minute video modules to assist with self-management of breast and nipple pain. These videos include: pain neurophysiology; non-pharmacological strategies; common BF issues and intervention; catastrophizing; stress reactivity; deep breathing; guided imagery and support (informational and instrumental). These mothers will also be asked to complete study questionnaires and measures at specified time points.

Usual care and asked to complete measures at follow-up time points.

Outcomes

Primary Outcome Measures

Pain Sensitivity
Quantitative sensory testing
Genetic variations in COMT
Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.

Secondary Outcome Measures

Increased duration of breastfeeding
With self-management of breast and nipple pain

Full Information

First Posted
January 2, 2018
Last Updated
March 8, 2021
Sponsor
University of Connecticut
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03392675
Brief Title
Breastfeeding Self-Management for Nipple and Breast Pain
Acronym
BSM
Official Title
Promoting Self-Management of Breast and Nipple Pain in Breastfeeding Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot project will provide an understanding of the contextual variables responsible for breast and nipple pain during breastfeeding initiation. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing and perceived stress. The purpose is to understand the efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing breastfeeding pain and its effect on improved health outcomes.
Detailed Description
Breastfeeding (BF) is one of the most important early determinants of infant health and development. Duration of BF is significantly related to reduced incidence of infantile respiratory and gastrointestinal tract infections, obesity and asthma. However, over 35% of mothers cease exclusive BF during the first 6 weeks due to nipple and breast pain. While 90% of mothers report acute nipple and breast pain during the first week of BF initiation, approximately 30% will experience persistent pain (>10 days). Due to the significant impact of nipple and breast pain on BF duration, pain is a significant barrier for achieving public health outcomes. The following pilot project will test the feasibility of a Breastfeeding Self-Management (BSM) Intervention on BF outcomes in mothers with nipple and breast pain. In addition, the proposed study will provide a preliminary examination of genetic, psychological and somatosensory factors that predict nipple and breast pain and possibly, early cessation of BF. Individual factors, including genetic polymorphisms of pain sensitivity genes and the individual's interpretation of pain can influence pain facilitation or inhibition at the molecular level of pain processing. Moreover, maternal anticipation of pain may increase pain catastrophizing, perceived stress and reactivity contributing to increased peripheral and central sensitivity. Identifying strategies to increase mothers' BF knowledge, pain self-efficacy and self-regulation skills could lead to increased SM behaviors. Therefore, this pilot study was designed to target pain SM process factors (self-monitoring, knowledge of breast care, BF self-efficacy, pain self-efficacy, and problem solving) relevant to mothers who experience pain during BF. The overarching goal of this program of research is to improve nipple and breast pain SM in BF mothers and enhance their BF self-efficacy to achieve their BF goals. The proposed study will address a major barrier of BF duration by identifying factors that contribute to nipple and breast pain. The proposed SM intervention will specifically target pain information, pain self-efficacy and problem-solving as central components of the SM process. In addition, the investigators will examine the influence of peripheral and central sensitivity and frequency of catechol-O-methyltransferase (COMT) single-nucleotide polymorphisms (SNPs), on SM process and outcome variables over time to gain knowledge about the precise influence of the molecular context of pain on risk of nipple and breast pain and BF outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Breast Pain
Keywords
Breast and Nipple Pain, Quantitative Sensory Testing, Genotyping, Breastfeeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Using a stratified and blocked randomization scheme.
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-monitoring of BF and intervention
Arm Type
Experimental
Arm Description
Self-monitoring and regulation skills will be provided to mothers at discharge. Aside from daily diaries outlining, infant feeding behaviors and pain, mothers will be instructed to watch several 5-minute video modules to assist with self-management of breast and nipple pain. These videos include: pain neurophysiology; non-pharmacological strategies; common BF issues and intervention; catastrophizing; stress reactivity; deep breathing; guided imagery and support (informational and instrumental). These mothers will also be asked to complete study questionnaires and measures at specified time points.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care and asked to complete measures at follow-up time points.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring of BF and intervention
Intervention Description
Self-Monitoring: At discharge, mothers will complete daily diaries for self-monitoring to stimulate cognitive reframing on the occurrence, duration, and characteristics of nipple and breast pain, infants' latch and sucking pattern, positioning, length of each BF session, and the MAIBB. Self-Regulation: To support self-regulation skills, mothers will be provided with several 5-minute video modules on pain and BF pain SM with additional resources links. After discharge mother will receive text message from a nurse 2X/week for BF support. Mothers may text the nurse for emergent BF support.
Primary Outcome Measure Information:
Title
Pain Sensitivity
Description
Quantitative sensory testing
Time Frame
Baseline
Title
Genetic variations in COMT
Description
Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Increased duration of breastfeeding
Description
With self-management of breast and nipple pain
Time Frame
Week 1, 2 and 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have just given birth (<48 hours) Intention to breastfeed for 6 weeks Has daily access to a computer with internet Access to a phone Read and speak English Delivered a healthy singleton infant born >37 weeks gestational age Exclusion Criteria: Infants with congenital anomalies Mothers with major mental health issues (i.e Schizophrenia, Mania, Bipolar Disorder) Complications during delivery requiring intervention Mothers with major health issues that are not associated with pregnancy as determined by principal investigator (i.e. infection illness such as HIV+, hepatitis, diabetes, history of seizures, current diagnosis of cancer).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Lucas, PhD, RN
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Manchester Memorial Hospital
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website. When will data be available (start and end dates)? Immediately. No end date. With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov. By what mechanism will data be made available? Data are available at cdRNS.nih.gov
IPD Sharing Time Frame
within 2 years
IPD Sharing Access Criteria
Requests will be submitted through the cdRNS website.
Citations:
PubMed Identifier
25588888
Citation
Breastfeeding. J Obstet Gynecol Neonatal Nurs. 2015 Jan-Feb;44(1):145-50. doi: 10.1111/1552-6909.12530. Epub 2015 Jan 14. No abstract available.
Results Reference
background
PubMed Identifier
23420922
Citation
Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for earlier than desired cessation of breastfeeding. Pediatrics. 2013 Mar;131(3):e726-32. doi: 10.1542/peds.2012-1295. Epub 2013 Feb 18.
Results Reference
background
PubMed Identifier
26426034
Citation
Kent JC, Ashton E, Hardwick CM, Rowan MK, Chia ES, Fairclough KA, Menon LL, Scott C, Mather-McCaw G, Navarro K, Geddes DT. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments. Int J Environ Res Public Health. 2015 Sep 29;12(10):12247-63. doi: 10.3390/ijerph121012247.
Results Reference
background
PubMed Identifier
25506813
Citation
Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;(12):CD007366. doi: 10.1002/14651858.CD007366.pub2.
Results Reference
background
Citation
Nicholas Penney, J., The biopsychosocial model of pain and contemporary osteopathic practice. International Journal of Osteopathic Medicine, 2010. 13(2): p. 42---47.
Results Reference
background
PubMed Identifier
25770578
Citation
Amir LH, Jones LE, Buck ML. Nipple pain associated with breastfeeding: incorporating current neurophysiology into clinical reasoning. Aust Fam Physician. 2015 Mar;44(3):127-32.
Results Reference
background
PubMed Identifier
15537663
Citation
Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
Results Reference
background
PubMed Identifier
30829925
Citation
Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336.
Results Reference
derived
Links:
URL
https://cappsm.nursing.uconn.edu/
Description
Center for Accelerating Precision Pain Self-Management (CAPPS-M) Website

Learn more about this trial

Breastfeeding Self-Management for Nipple and Breast Pain

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