NCT03392675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

January 2, 2018

Last Update Submit

March 8, 2021

Conditions

BreastfeedingBreast Pain

Keywords

Breast and Nipple PainQuantitative Sensory TestingGenotypingBreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Pain Sensitivity

    Quantitative sensory testing

    Baseline

  • Genetic variations in COMT

    Pain susceptibility SNPs genotyping related to breastfeeding related breast and nipple pain.

    Baseline

Secondary Outcomes (1)

  • Increased duration of breastfeeding

    Week 1, 2 and 6

Study Arms (2)

Self-monitoring of BF and intervention

EXPERIMENTAL

Self-monitoring and regulation skills will be provided to mothers at discharge. Aside from daily diaries outlining, infant feeding behaviors and pain, mothers will be instructed to watch several 5-minute video modules to assist with self-management of breast and nipple pain. These videos include: pain neurophysiology; non-pharmacological strategies; common BF issues and intervention; catastrophizing; stress reactivity; deep breathing; guided imagery and support (informational and instrumental). These mothers will also be asked to complete study questionnaires and measures at specified time points.

Behavioral: Self-monitoring of BF and intervention

Control

NO INTERVENTION

Usual care and asked to complete measures at follow-up time points.

Interventions

Self-monitoring of BF and interventionBEHAVIORAL

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.

Self-monitoring of BF and intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have just given birth (\<48 hours)
  • Intention to breastfeed for 6 weeks
  • Has daily access to a computer with internet
  • Access to a phone
  • Read and speak English
  • Delivered a healthy singleton infant born \>37 weeks gestational age

You may not qualify if:

  • Infants with congenital anomalies
  • Mothers with major mental health issues (i.e Schizophrenia, Mania, Bipolar Disorder)
  • Complications during delivery requiring intervention
  • Mothers with major health issues that are not associated with pregnancy as determined by principal investigator (i.e. infection illness such as HIV+, hepatitis, diabetes, history of seizures, current diagnosis of cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States

Location

Related Publications (8)

  • Breastfeeding. J Obstet Gynecol Neonatal Nurs. 2015 Jan-Feb;44(1):145-50. doi: 10.1111/1552-6909.12530. Epub 2015 Jan 14. No abstract available.

    PMID: 25588888BACKGROUND

  • Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for earlier than desired cessation of breastfeeding. Pediatrics. 2013 Mar;131(3):e726-32. doi: 10.1542/peds.2012-1295. Epub 2013 Feb 18.

    PMID: 23420922BACKGROUND

  • Kent JC, Ashton E, Hardwick CM, Rowan MK, Chia ES, Fairclough KA, Menon LL, Scott C, Mather-McCaw G, Navarro K, Geddes DT. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments. Int J Environ Res Public Health. 2015 Sep 29;12(10):12247-63. doi: 10.3390/ijerph121012247.

    PMID: 26426034BACKGROUND

  • Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2.

    PMID: 25506813BACKGROUND

  • Nicholas Penney, J., The biopsychosocial model of pain and contemporary osteopathic practice. International Journal of Osteopathic Medicine, 2010. 13(2): p. 42---47.

    BACKGROUND

  • Amir LH, Jones LE, Buck ML. Nipple pain associated with breastfeeding: incorporating current neurophysiology into clinical reasoning. Aust Fam Physician. 2015 Mar;44(3):127-32.

    PMID: 25770578BACKGROUND

  • Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.

    PMID: 15537663BACKGROUND

  • Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336.

    PMID: 30829925DERIVED

Related Links

MeSH Terms

Conditions

Breast FeedingMastodynia

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ruth Lucas, PhD, RN

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Using a stratified and blocked randomization scheme.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

April 24, 2017

Primary Completion

November 6, 2017

Study Completion

November 7, 2017

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website. When will data be available (start and end dates)? Immediately. No end date. With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov. By what mechanism will data be made available? Data are available at cdRNS.nih.gov

Time Frame
within 2 years
Access Criteria
Requests will be submitted through the cdRNS website.

Locations

US(2)