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Completed

NCT Number: NCT03392675

Breastfeeding Self-Management for Nipple and Breast Pain

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health, Farmington, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Self-monitoring of BF and intervention

Behavioral

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 outcomes

  1. Pain Sensitivity

    Time frame: Baseline

    Quantitative sensory testing

  2. Genetic variations in COMT

    Time frame: Baseline

    Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.

Secondary outcomes

  1. Increased duration of breastfeeding

    Time frame: Week 1, 2 and 6

    With self-management of breast and nipple pain

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: BSM

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2018
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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