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

In response to the critical gap that exists in identifying effective biobehavioral self-management interventions for participants during BF initiation who experience breast and nipple pain (BNP), the investigators developed a patient-informed Breastfeeding and BNP Self-Management (BSM) intervention based on the Individual and Family Self-Management Theory. The investigators propose to test the effectiveness of the BSM intervention on BNP severity, pain interference with daily life, and BF outcomes over time in this R56NR020041 Randomized Control Trial, Promoting Self-Management of Breast and Nipple Pain with Technology (PROMPT) for Breastfeeding Women. Participants (N=222) intending to BF will be randomized either to receive the BSM intervention or be in the attention control group, with assessments performed after birth at the hospital (baseline). After screening and informed consent, participants will be asked to complete study measures, undergo quantitative sensory testing using a standardized protocol, and access a secure electronic survey site via participants' smartphone or study-provided smartphone text links or email before discharge home. During the first week home, all participants will receive bi-weekly texts with links to BSM intervention BF modules or for the attention control group, educational modules on postpartum recovery and infant care. All participants at 1, 2, 3, 9, 12, and 18 weeks will receive a text or email for ongoing assessments of BNP and BF measures of the exclusivity (breast, breast milk, or formula), the number of feedings each day, and how long (days/weeks/months) infants were breastfed (duration). In addition, the study occurs via mobile technology during an acute period of pain when the rate of BF cessation is the highest. At 6- and 24-weeks participants will repeat the study measures and quantitative sensory testing.

The PROMPT study is the first to target self-management for BNP using cloud-based educational modules and user-preferred text-based smartphone intervention during the critical weeks of BF initiation, when support for BF is most desired, face-to-face visits are most burdensome, and places the mother-infant dyads at risk for illness, such as COVID-19. The study will describe how many participants experience BNP from BF initiation to 24 weeks as participants return to work and who may be at risk for chronic pain, which has not been examined. The study also replicates and expands on how the presence of pain sensitivity affects BNP and BF outcomes. The results from this study hold great promise to 1) support a diverse population of BF participants by identifying the risk factors of BNP; 2) target personal interventions for participants experiencing BNP based on unique moderating factors of pain sensitivity, nonpharmacological interventions, BF self-efficacy, pain coping, maternal self-efficacy and maternal well-being (anxiety, depression, stress, and fatigue); and 3) to develop easily accessible strategies for participants BF within clinical settings that allow for large-scale translation in health care systems or public health settings.

Participant Recruitment will begin by active and passive methods successfully used in the pilot study with the addition of prenatal recruitment in the clinical site. Passive methods include (1) advertisements via Facebook pages (Connecticut Breastfeeding Coalition and the School of Nursing Center for the Advancement of Management of Pain (CAMP)) and Instagram ads, targeting participants in Connecticut who intend to BF, (2) flyers posted at clinical partners offices, (3) flyers given by the clinical partners to participants expressing interest in BF during routine prenatal care and referring participants to the peer counselors, research assistants, or lactation consultants team members on the inpatient hospital units, (4) flyers included in discharge educational packets at both recruitment sites, (5) flyers posted in hospital (HH, University of Connecticut Medical Center (UConn Health) common areas.

Active methods include screening the inpatient unit census two to three times per week by the clinical partners for participants who meet inclusion or exclusion criteria. Participants who agree to speak with a member of the research team about the study will be approached. A HIPAA consent will be obtained for the research team to ask initial screening questions via REDCap (Research Electronic Data Capture). REDCap is a secure web application and database storage for creating and managing online data collection with highly customizable data types (including 21 Code of Federal Regulations (CFR) Title 21 Part 11, Federal Information Security Modernization Act (FISMA), and Health Insurance Portability and Accountability Act (HIPAA) compliant environments). If eligible, informed consent will be obtained by a member of the research team trained in obtaining informed consent and approved by the Institutional Review Board (IRB).

The investigators will recruit participants after birth, with data collection to occur before discharge from the hospital and take approximately 60 minutes. To decrease participant burden, recruitment will begin during the antenatal care so participants may anticipate participating in data collection after delivery. In BSM pilot study, the retention rate was 94% of participants at 6 weeks, and as the primary aim is the effectiveness of the intervention during the first 3 weeks, the sample size calculations account for the possibility of loss-to-follow-up as high as 5% at 3 weeks. Additionally, the investigators anticipate the possibility of a 25% attrition rate at 24 weeks, a level somewhat larger than the 15-20% rate observed in many longitudinal intervention trials.