Study 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.
Eligible Conditions
- Acute Pain
- Parent-Child Relationship
- Exclusive Breastfeeding
- Maternal Distress
- Self-Efficacy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: Baseline to 24 weeks
Baseline to 24 weeks
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 a self-report visual analogue scale from baseline to 24 weeks.
Percentage of participants who continue to breastfeeding from baseline to 24 weeks via self-report
Baseline to 24 weeks.
Breast and nipple pain severity measured by Brief Pain Inventory pain interference summary score from baseline to 24 weeks.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Attention Control
1 of 2
The BSM Intervention
1 of 2
Active Control
Experimental Treatment
222 Total Participants · 2 Treatment Groups
Primary Treatment: The BSM Intervention · No Placebo Group · N/A
The BSM Intervention
Behavioral
Experimental Group · 1 Intervention: The BSM Intervention · Intervention Types: BehavioralAttention Control
Behavioral
ActiveComparator Group · 1 Intervention: Attention Control · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24 weeks
Who is running the clinical trial?
UConn HealthOTHER
197 Previous Clinical Trials
58,076 Total Patients Enrolled
University of ConnecticutLead Sponsor
161 Previous Clinical Trials
156,344 Total Patients Enrolled
Hartford HealthCareOTHER
6 Previous Clinical Trials
674 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
529 Previous Clinical Trials
10,287,508 Total Patients Enrolled
2 Trials studying Acute Pain
473 Patients Enrolled for Acute Pain
Ruth F Lucas, PhDPrincipal InvestigatorUniversity of Connecticut
Eligibility Criteria
Age 18 - 45 · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lucas RF, McGrath JM. Clinical assessment and management of breastfeeding pain. Top Pain Manag. 2016;32(3):1-12.
- Subnis UB, Starkweather A, Menzies V. A current review of distraction-based interventions for chronic pain management. Eur J Integr Med. 2016;8(5):715-722. doi:10.1016/j.eujim.2016.08.162
- Litt, Mark D, and Howard Tennen. 2015. “What Are the Most Effective Coping Strategies for Managing Chronic Pain?”. Pain Management. Future Medicine Ltd. doi:10.2217/pmt.15.45.
- Gallegos, Danielle, Rebekah Russell-Bennett, Josephine Previte, and Joy Parkinson. 2014. “Can a Text Message a Week Improve Breastfeeding?”. BMC Pregnancy and Childbirth. Springer Science and Business Media LLC. doi:10.1186/s12884-014-0374-2.
- Lucas, Ruth, Katherine Bernier, Mallory Perry, Heather Evans, Divya Ramesh, Erin Young, Stephen Walsh, and Angela Starkweather. 2019. “Promoting Self‐management of Breast and Nipple Pain in Breastfeeding Women: Protocol of a Pilot Randomized Controlled Trial”. Research in Nursing & Health. Wiley. doi:10.1002/nur.21938.
- Lucas, Ruth, Yiming Zhang, Stephen J. Walsh, Heather Evans, Erin Young, and Angela Starkweather. 2019. “Efficacy of a Breastfeeding Pain Self-management Intervention: A Pilot Randomized Controlled Trial”. Nursing Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/nnr.0000000000000336.
- Ryan, Polly, and Kathleen J. Sawin. 2009. “The Individual and Family Self-management Theory: Background and Perspectives on Context, Process, and Outcomes”. Nursing Outlook. Elsevier BV. doi:10.1016/j.outlook.2008.10.004.
- Litt MD, Tennen H. What are the most effective coping strategies for managing chronic pain? Pain Manag. 2015;5(6):403-6. doi: 10.2217/pmt.15.45. Epub 2015 Sep 24. No abstract available.
- Ruth Lucas 2022. "Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05262920.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments