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

NCT05262920 | Completed Results

• 2 other identifiers: E21-0205R56NR020041
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Breastfeeding, Pain, Self-efficacy

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale for Breast and Nipple Pain Severity

  Visual analogue scale (0-100) uses an unlabeled line with scores further to the right indicating higher scores and increased pain

  Baseline to 24 weeks

• Brief Pain Inventory Pain Intensity Scale

  The Brief Pain Inventory pain intensity sum score of 4 items (3, 4, 5, and 6). Each item is scored 0-10, the pain intensity sum score ranges from 0-40. The higher the score the worse the pain. A composite score of the average is sometimes reported. Factor analysis verified the two separate factors, pain intensity and interference, found in the previous study. Internal stability (Cronbach alpha) was also examined in this study. Alphas showed good internal consistency, ranging from 0.80 to 0.87 for the four pain intensity items.

  Baseline to 24 weeks

• Brief Pain Inventory Interference Scale

  The Brief Pain Inventory Pain Interference score is the average sum score of 7 items 9a - 9g. Each item is scored 0-5, with a total score of 0-35. Higher scores mean worse pain. A composite score of the average is sometimes reported. Factor analysis verified the two separate factors, pain intensity and interference, found in the previous study. Internal stability (Cronbach alpha) was also examined in this study. Alphas showed good internal consistency, ranging from 0.89 to 0.92 for the seven interference item.

  Baseline to 24 weeks.

• Cumulative Breast and Nipple Pain Scores

  Each weekly score uses the visual analogue score of 0-100. Cumulative Breast and Nipple Pain (BNP) is calculated each week as a summed additive score. Participants' cumulative BNP (baseline +1 week, + 2 weeks, + 3 weeks, + 6 weeks, + 9 weeks, + 12 weeks, +18 weeks, 24 weeks, 0 - 900). Higher cumulative scores represent greater BNP severity. Only individuals who remain in the study scores are reported.

  Baseline to 24 Weeks

Secondary Outcomes (7)

• Breastfeeding Exclusivity Participation Rate

  Baseline to 24 weeks

• Breastfeeding Self-Efficacy Scale

  Baseline to 24 weeks

• Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a

  Baseline to 24 weeks

• Edinburgh Postnatal Depression Scale

  Baseline to 24 weeks

• Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a

  Baseline to 24 weeks

Study Arms (2)

The BSM Intervention

EXPERIMENTAL

Guided by the Individual and Family Self-Management Theory, the Lucas team developed the Breastfeeding and BNP Self-Management (BSM) intervention. The BSM intervention uses a cloud-based platform, links to educational modules, and daily journaling, to provide women uniform best practice knowledge and skills for BF and BNP self-management. Strategies include guided imagery, therapeutic breathing, mindfulness, relaxation, non-pharmacological interventions that are integrated within the self-management process such as goal-setting, self-monitoring, problem-solving, and social support through texting.

Behavioral: The BSM Intervention

Attention Control

ACTIVE COMPARATOR

Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the Centers for Disease Control (CDC) HEAR HER campaign and infant health information modules will be provided through the REDCap link.

Behavioral: Attention Control

Interventions

The BSM Intervention BEHAVIORAL

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).

The BSM Intervention

Attention Control BEHAVIORAL

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

Attention Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female able to directly breastfeed. Males and transgender males at this time are unable to BF and not eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• women
• years of age
• Gave birth \< 48 hours to a singleton infant \> 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
• \< 18 or \> 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

Sponsors & Collaborators

• University of Connecticut: lead
• Hartford HealthCare: collaborator
• UConn Health: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Related Publications (8)

• Lucas RF, McGrath JM. Clinical assessment and management of breastfeeding pain. Top Pain Manag. 2016;32(3):1-12.

  BACKGROUND

• Lucas R, Bernier K, Perry M, Evans H, Ramesh D, Young E, Walsh S, Starkweather A. Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial. Res Nurs Health. 2019 Jun;42(3):176-188. doi: 10.1002/nur.21938. Epub 2019 Mar 5.

  PMID: 30835887 BACKGROUND

• 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.

  PMID: 30829925 BACKGROUND

• Gallegos D, Russell-Bennett R, Previte J, Parkinson J. Can a text message a week improve breastfeeding? BMC Pregnancy Childbirth. 2014 Nov 6;14:374. doi: 10.1186/s12884-014-0374-2.

  PMID: 25369808 BACKGROUND

• Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.

  PMID: 19631064 BACKGROUND

• Subnis UB, Starkweather A, Menzies V. A current review of distraction-based interventions for chronic pain management. Eur J Integr Med. 2016;8(5):715-722. doi:10.1016/j.eujim.2016.08.162

  BACKGROUND

• Litt MD, Tennen H. What are the most effective coping strategies for managing chronic pain? Pain Manag. 2015;5(6):403-6. doi: 10.2217/pmt.15.45. Epub 2015 Sep 24. No abstract available.

  PMID: 26399377 BACKGROUND

• Aderibigbe T, Kelleher SL, Henderson WA, Prescott S, Young EE, Lucas RF. COMT Variants are Associated With Breast and Nipple Pain. J Pain. 2024 Sep;25(9):104568. doi: 10.1016/j.jpain.2024.104568. Epub 2024 May 18.

  PMID: 38763257 DERIVED

MeSH Terms

Conditions

Breast Feeding; Acute Pain; Pain

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ruth Lucas
• Organization: University of Conecticut (UConn)

ruth.lucas@uconn.edu

6397384113

Study Officials

• Ruth F Lucas, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators will employ blinding whenever possible. The investigators team members involved in data collection or analysis will be blinded to the group assignment of participants. Research team personnel will follow a strict script to refrain from discussing participant activities, and by using the data management graduate assistant (unblinded) to coordinate assigned condition activities and data collection and analysis. All participants will be assigned a study number, which will be used to track the study measures. De-identified data with dummy codes for assigned condition will be entered into the study database to allow blinded data analysis. Blinding was successfully employed during the BSM pilot study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The proposed Randomized Control Trial (RCT),will be conducted to test the effect of the BSM intervention vs. an attention control group on BNP, BF exclusivity and duration, BF self-efficacy, and maternal well-being to 24 weeks

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 2, 2022
• Study Start: March 16, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Datasets will also be shared with other qualified researchers after major publications have been accepted which will be 5 years after the study is completed.
• Access Criteria: Datasets will be made readily available for sharing across the maternal child and BF research groups at the UConn. Furthermore, we will welcome collaboration with maternal child clinicians and others who may make use of the study protocols developed in the proposed study.

Locations

US (2)