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Breastfeeding Self-Management for Nipple and Breast Pain

NCT03392675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-03-11

No results posted yet for this study

Summary

This pilot project will provide an understanding of the contextual variables responsible for breast and nipple pain during breastfeeding initiation. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing and perceived stress. The purpose is to understand the efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing breastfeeding pain and its effect on improved health outcomes.

Conditions

  • Breastfeeding
  • Breast Pain

Interventions

BEHAVIORAL

Self-monitoring of BF and intervention

Self-Monitoring: At discharge, mothers will complete daily diaries for self-monitoring to stimulate cognitive reframing on the occurrence, duration, and characteristics of nipple and breast pain, infants' latch and sucking pattern, positioning, length of each BF session, and the MAIBB. Self-Regulation: To support self-regulation skills, mothers will be provided with several 5-minute video modules on pain and BF pain SM with additional resources links. After discharge mother will receive text message from a nurse 2X/week for BF support. Mothers may text the nurse for emergent BF support.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Connecticut

    lead OTHER

Principal Investigators

  • Ruth Lucas, PhD, RN · University of Connecticut

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2017-11-06
Completion
2017-11-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03392675 on ClinicalTrials.gov