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NCT05262920 · ClinicalTrials.gov registry record · NA
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
A NA study, sponsored by University of Connecticut.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT05262920 is a NA study that has completed, run by University of Connecticut. The registered enrollment target is 250 participants.
The verdict
NCT05262920, a NA study, has completed, sponsored by University of Connecticut.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
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, a
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL The BSM Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2022-03-16 |
| Est. Completion | 2023-12-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05262920
The ClinicalTrials.gov registry entry for NCT05262920 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Connecticut, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Attention Control is the first listed.
NCT05262920 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05262920 about?
NCT05262920 is a clinical study titled "Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study". 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 (B...
What is the current status of trial NCT05262920?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2022-03-16. Estimated completion is 2023-12-18.
What interventions are being tested in trial NCT05262920?
The interventions under investigation include: Attention Control (BEHAVIORAL), The BSM Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05262920?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
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