Breastfeeding Self-Management for Nipple and Breast Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breastfeeding, Breast Pain

Intervention / Treatment
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* Behavioral: Self-monitoring of BF and intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-monitoring of BF and intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Usual care and asked to complete measures at follow-up time points. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Sensitivity | Quantitative sensory testing | Baseline | 
| Genetic variations in COMT | 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 | With self-management of breast and nipple pain | Week 1, 2 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast and Nipple Pain, Quantitative Sensory Testing, Genotyping, Breastfeeding