Breastfeeding Self-Management for Nipple and Breast Pain

Breastfeeding Clinical Trial

— BSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392675
• Other study ID #: H16-321
• Secondary ID: 5P20NR016605-02
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: November 7, 2017

Study information

• Verified date: March 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 7, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Pain
• Breastfeeding
• Mastodynia

Intervention

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.

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut
United States	Manchester Memorial Hospital	Manchester	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

Breastfeeding. J Obstet Gynecol Neonatal Nurs. 2015 Jan-Feb;44(1):145-50. doi: 10.1111/1552-6909.12530. Epub 2015 Jan 14. — View 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. Review. — View 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. Epub 2004 Nov 10. — View 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Sensitivity	Quantitative sensory testing	Baseline
Primary	Genetic variations in COMT	Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.	Baseline
Secondary	Increased duration of breastfeeding	With self-management of breast and nipple pain	Week 1, 2 and 6

External Links

•   Center for Accelerating Precision Pain Self-Management (CAPPS-M) Website