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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20NR016605-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-monitoring of BF and intervention | Experimental | 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. |
|
| Control | No Intervention | Usual care and asked to complete measures at follow-up time points. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increased duration of breastfeeding | With self-management of breast and nipple pain | Week 1, 2 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Lucas, PhD, RN | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States | ||
| Manchester Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25588888 | Background | Breastfeeding. J Obstet Gynecol Neonatal Nurs. 2015 Jan-Feb;44(1):145-50. doi: 10.1111/1552-6909.12530. Epub 2015 Jan 14. No abstract available. | |
| 23420922 | Background | 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. |
| Label | URL |
|---|---|
| Center for Accelerating Precision Pain Self-Management (CAPPS-M) Website | View source |
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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
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within 2 years
Requests will be submitted through the cdRNS website.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 11, 2017 | Jan 7, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Using a stratified and blocked randomization scheme.
|
| Manchester |
| Connecticut |
| 06040 |
| United States |
| 26426034 | Background | 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. |
| 25506813 | Background | Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2. |
| Background | Nicholas Penney, J., The biopsychosocial model of pain and contemporary osteopathic practice. International Journal of Osteopathic Medicine, 2010. 13(2): p. 42---47. |
| 25770578 | Background | 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. |
| 15537663 | Background | 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. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10. |
| 30829925 | Derived | Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |