Status:
COMPLETED
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Lead Sponsor:
University of Connecticut
Collaborating Sponsors:
Hartford HealthCare
UConn Health
Conditions:
Breastfeeding, Exclusive
Pain, Acute
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Please reformat the Eligibility Criteria. The preferred format includes bulleted lists of inclusion and exclusion criteria as shown below.
- women
- 18 - 45 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
Exclusion
- \< 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05262920
Start Date
March 16 2022
End Date
December 18 2023
Last Update
July 18 2025
Active Locations (2)
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1
UConn Health
Farmington, Connecticut, United States, 06030
2
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037