N/A
N=250
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Breastfeeding, Exclusive · Pain, Acute · Maternal Distress · Parent-Child Relations · Self Efficacy
Bottom Line
View on ClinicalTrials.gov: NCT05262920 ↗Enrolled (actual)
250
Serious AEs
30.0%
Results posted
Jan 2026
Primary outcome: Primary: Visual Analogue Scale for Breast and Nipple Pain Severity — 39.43; 36.55; 44.31; 36.93 units on a scale — p=<0.0045
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The BSM Intervention (Behavioral); Attention Control (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Connecticut
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale for Breast and Nipple Pain Severity |
39.43; 36.55; 44.31; 36.93; 33.8; 25.68 | <0.0045 sig |
| PRIMARY Brief Pain Inventory Pain Intensity Scale |
3.88; 3.79; 3.56; 3.72; 2.89; 3.24 | 0.65 |
| PRIMARY Brief Pain Inventory Interference Scale |
3.38; 3.55; 2.27; 2.46; 1.92; 2.00 | 0.681 |
| PRIMARY Cumulative Breast and Nipple Pain Scores |
36.55; 39.43; 72.47; 84.36; 98.57; 117.64 | <0.011 sig |
| SECONDARY Breastfeeding Exclusivity Participation Rate |
119; 118; 67; 74; 56; 70 | 0.135 |
| SECONDARY Breastfeeding Self-Efficacy Scale |
45.28; 45.49; 51.44; 51.26; 53.24; 51.62 | 0.571 |
| SECONDARY Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a |
51.56; 51.27; 48.35; 49.81; 47.02; 48.36 | 0.186 |
| SECONDARY Edinburgh Postnatal Depression Scale |
5.56; 6.03; 4.56; 5.76; 4.05; 4.50 | 0.191 |
| SECONDARY Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a |
53.99; 54.95; 51.72; 54.48; 50.98; 52.26 | 0.09 |
| SECONDARY Perceived Stress Scale10 Form V.09/16/13 |
12.94; 12.93; 11.52; 12.68; 10.71; 11.44 | 0.672 |
| SECONDARY Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a |
52.35; 54.13; 49.32; 50.69; 48.10; 48.91 | 0.221 |
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.
Eligibility Criteria
Please reformat the Eligibility Criteria. The preferred format includes lists of inclusion and exclusion criteria as shown below.
Inclusion Criteria
- women
- 18 - 45 years of age
- Gave birth 37 weeks gestational age
- Intend to BF
- Received standardized BF basics during their antenatal care
- Access to the internet via own smartphone or study provided smartphone
- Able to read and write English
- Assessed by lactation consultant during BF
Exclusion Criteria
- 45 years of age
- History of significant mental health disorder (e.g., major depression, schizophrenia, or bipolar disorder) due to additional challenges in the capacity for self-management
- Skin conditions on nondominant forearm which could interfere with quantitative sensory testing
- Birth of an infant with medical complications or congenital anomalies
Data sourced from ClinicalTrials.gov (NCT05262920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.