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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03392675
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : March 11, 2021
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Breastfeeding Breast Pain Behavioral: Self-monitoring of BF and intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Using a stratified and blocked randomization scheme.
Primary Purpose: Supportive Care
Official Title: Promoting Self-Management of Breast and Nipple Pain in Breastfeeding Women
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 7, 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Increased duration of breastfeeding [ Time Frame: Week 1, 2 and 6 ]
    With self-management of breast and nipple pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392675

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United States, Connecticut
UConn Health
Farmington, Connecticut, United States, 06030
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
Sponsors and Collaborators
University of Connecticut
National Institute of Nursing Research (NINR)
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Principal Investigator: Ruth Lucas, PhD, RN University of Connecticut
  Study Documents (Full-Text)

Documents provided by University of Connecticut:
Informed Consent Form  [PDF] May 11, 2017

Additional Information:
Nicholas Penney, J., The biopsychosocial model of pain and contemporary osteopathic practice. International Journal of Osteopathic Medicine, 2010. 13(2): p. 42---47.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT03392675    
Other Study ID Numbers: H16-321
5P20NR016605-02 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Time Frame: within 2 years
Access Criteria: Requests will be submitted through the cdRNS website.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Connecticut:
Breast and Nipple Pain
Quantitative Sensory Testing
Additional relevant MeSH terms:
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Neurologic Manifestations