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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Page 1 of 1 (2 locations)

1

UConn Health

Farmington, Connecticut, United States, 06030

2

Hartford Hospital

Hartford, Connecticut, United States, 06102-5037