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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
18 - 45 years of age
Assessed by lactation consultant during breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

PROMPT Trial 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.Check my eligibility
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.See study design
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.

PROMPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 45 years old.
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Evaluated by a breastfeeding expert while breastfeeding.
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Gave birth to a baby within the last 48 hours who was full-term (at least 37 weeks gestational age)
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You have received basic education about breastfeeding during your prenatal care.

PROMPT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Percentage of participants who continue to breastfeeding from baseline to 24 weeks via self-report

PROMPT 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

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor
181 Previous Clinical Trials
157,946 Total Patients Enrolled
Hartford HealthCareOTHER
8 Previous Clinical Trials
1,034 Total Patients Enrolled
UConn HealthOTHER
211 Previous Clinical Trials
60,371 Total Patients Enrolled

Media Library

The BSM Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05262920 — N/A
Exclusive Breastfeeding Research Study Groups: The BSM Intervention, Attention Control
Exclusive Breastfeeding Clinical Trial 2023: The BSM Intervention Highlights & Side Effects. Trial Name: NCT05262920 — N/A
The BSM Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05262920 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 45+ eligible for participation in this investigation?

"As outlined in the entrance requirements, individuals with ages between 18 and 45 are eligible to participate."

Answered by AI

Are participants being taken for this medical experiment at present?

"Affirmative. Information on clinicaltrials.gov verifies that this research project, which was first posted in March 16th 2022, is actively recruiting participants. Specifically, 222 individuals need to be recruited at 2 separate medical sites."

Answered by AI

Could I be eligible to partake in this medical investigation?

"To qualify for entry into the trial, patients must have acute pain and be between 18 - 45 years old. Currently 222 individuals are accepted to take part in this clinical study."

Answered by AI

What is the current enrollment numbers of this research study?

"Affirmative. Clinical trials data affirms that this study is presently searching for volunteers, having been posted on March 16th 2022 and updated most recently in June 15th 2022. Recruitment will target 222 patients split between 2 sites."

Answered by AI
Recent research and studies
~83 spots leftby Mar 2025