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Completed NON-SBIR/STTR RPGS NIH (US)

Promoting Self-Management of Breast and Nipple Pain with Technology (PROMPT) for Breastfeeding Women

$4.85M USD

Funder NATIONAL INSTITUTE OF NURSING RESEARCH
Recipient Organization University of Connecticut Storrs
Country United States
Start Date Sep 22, 2021
End Date Jul 31, 2023
Duration 677 days
Number of Grantees 1
Roles Principal Investigator
Data Source NIH (US)
Grant ID 10480351
Grant Description

Project Summary Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal well-being and infant?s health, physical growth, and development.

The highest rate of BF cessation occurs within 3 weeks after delivery, with 30% of women ceasing BF due to acute breast and nipple pain (BNP).

BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signaling that stimulates multiple pathways - somatic, visceral, and the autonomic nervous system.

Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, increased maternal distress symptoms, which contribute to early BF cessation, decreased maternal well-being, and maternal self-efficacy.

Our team developed and tested a 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory.

Aligned with the NINR?s strategic themes of symptoms science and self-management and the CDC HEAR HER campaign and the needs and preferences elicited from a diverse sample of BF women, we used a cloud-based platform, to deliver BF knowledge and skills, and provided support through nurse led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits and risk for illness, such as COVID-19, and increase adaptive coping behaviors.

The BSM intervention provides specific strategies for behavioral and active self-management of BNP and BF challenges.

Women in the BSM intervention group reported significantly reduced BNP intensity and pain interference at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks.

BNP intensity was associated with pain sensitivity single nucleotide polymorphisms (SNPs) (Oxytocin receptor (OXTR) rs53576, rs2254298), suggesting a genetic risk profile of heightened BNP which may be used to identify women at high risk of early BF cessation and general pain sensitivity.

Based on these promising results, we propose to examine the efficacy of the BSM intervention in a RO1 RCT, Promoting Self-Management of Breast and Nipple Pain with Biomarkers and Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity.

Using state-of-the-art methods for assessing pain sensitivity and genetic risk for BNP, the study will reproduce and extend our pilot findings by exploring pain genetics influence on BNP in order to screen prenatally women at-risk for pain-associated BF cessation and enhance pain sensitivity.

The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, and BF, pain, and maternal self-efficacy, on BF exclusivity.

Women (N = 280) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks.

Study results will advance knowledge on the BSM intervention, with direct implications for nurse- designed and nurse-led self-management interventions in clinical settings or health care systems.

All Grantees

University of Connecticut Storrs

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