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

Summary

Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal and infant health, development, and well-being. The highest rate of BF cessation occurs within 3 weeks after birth, 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 pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy, a key predictor of BF at 6 months and increased maternal distress symptoms contributing to differences in early BF cessation rates. The investigators developed and tested their 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 needs and preferences elicited from BF participants, the investigators 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 increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56NR020041 Randomized Control Trial (RCT), Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) 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 lead self-management interventions in clinical settings or health care systems.

Conditions

• Breastfeeding, Exclusive
• Pain, Acute
• Maternal Distress
• Parent-Child Relations
• Self Efficacy

Interventions

BEHAVIORAL

The BSM Intervention

The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).

BEHAVIORAL

Attention Control

The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; Coronavirus disease 2019 (COVID-19) and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace

Sponsors & Collaborators

• Hartford HealthCare

  collaborator OTHER

• UConn Health

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Connecticut

  lead OTHER

Principal Investigators

• Ruth F Lucas, PhD · University of Connecticut

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-16

Primary Completion

2023-12-18

Completion

2023-12-18

Countries

• United States

Study Locations