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

March 8, 2021 updated by: University of Connecticut

Promoting Self-Management of Breast and Nipple Pain in Breastfeeding Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UCONN Health
      • Manchester, Connecticut, United States, 06040
        • Manchester Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-monitoring of BF and intervention
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.
Behavioral: Self-monitoring of BF and intervention

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.
No Intervention: Control
Usual care and asked to complete measures at follow-up time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Sensitivity
Time Frame: Baseline
Quantitative sensory testing
Baseline
Genetic variations in COMT
Time Frame: Baseline
Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased duration of breastfeeding
Time Frame: Week 1, 2 and 6
With self-management of breast and nipple pain
Week 1, 2 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Ruth Lucas, PhD, RN, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

November 6, 2017

Study Completion (Actual)

November 7, 2017

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-321
  • 5P20NR016605-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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