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Self-Management Intervention for Breastfeeding Pain (PROMPT Trial)

N/A

Waitlist Available

Led By Ruth F Lucas, PhD

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a self-management intervention for breastfeeding and breast and nipple pain to see if it decreases pain intensity and interference and increases breastfeeding exclusivity.

Who is the study for?

This trial is for breastfeeding women aged 18-45 who have internet access, can read/write English, recently gave birth to a healthy single baby at full term, and plan to breastfeed. They must have received basic breastfeeding education and be assessed by a lactation consultant.

What is being tested?

The study tests the Breastfeeding Self-Management (BSM) intervention using technology to manage breast and nipple pain versus an attention control group. It aims to reduce pain intensity, improve self-efficacy in breastfeeding mothers, and increase exclusive breastfeeding rates.

What are the potential side effects?

Since this trial involves educational support rather than medication or invasive procedures, side effects are minimal but may include potential discomfort from engaging with the technology or emotional distress if interventions do not alleviate pain as expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Breast and nipple pain severity measured by Brief Pain Inventory pain intensity summary score from baseline to 24 weeks.

Breast and nipple pain severity measured by Brief Pain Inventory pain interference summary score from baseline to 24 weeks.

Breast and nipple pain severity measured by a self-report visual analogue scale from baseline to 24 weeks.

Secondary study objectives

Percentage of participants who continue to breastfeeding from baseline to 24 weeks via self-report

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: The BSM InterventionExperimental Treatment1 Intervention

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.

Group II: Attention ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

The BSM Intervention

2022

N/A

~250

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