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Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.

ABSTRACT: The majority of women experience pain during breastfeeding initiation with few strategies to manage breast and nipple pain. In fact, women cite breast and nipple pain as among the most common reasons for breastfeeding cessation. To address this important issue, we developed a breastfeeding self-management (BSM) intervention, based on the Individual and Family Self-Management Theory Framework. In this framework, self-management is conceptualized as a process in which women use knowledge, beliefs, and social facilitation to achieve breastfeeding goals. The purpose of this longitudinal pilot randomized controlled trial was to test the feasibility, acceptability, and preliminary efficacy of the BSM intervention with women initiating breastfeeding. Recruitment of 60 women intending to breastfeed occurred within 48?hr of delivery and women were randomized to either the intervention or usual care group. The BSM intervention group received BSM education modules that included information of how to manage breast and nipple pain and self-management support through biweekly texting from the study nurse, and were asked to complete a daily breastfeeding journal. Primary outcomes measured at baseline, 1, 2, and 6 weeks will be used to (a) evaluate feasibility, acceptability, and preliminary efficacy of the BSM intervention, and (b) assess the influence of protective and risk factors of breastfeeding pain (including individual genetic polymorphisms related to pain sensitivity) on process variables for self-management of breastfeeding and breastfeeding pain, and on proximal (breastfeeding pain severity and interference, breastfeeding frequency) and distal outcomes (breastfeeding exclusivity and duration and general well-being).

SUBMITTER: Lucas R

PROVIDER: S-EPMC6481628 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.

Lucas Ruth R Bernier Katherine K Perry Mallory M Evans Heather H Ramesh Divya D Young Erin E Walsh Stephen S Starkweather Angela A

Research in nursing & health 20190305 3

The majority of women experience pain during breastfeeding initiation with few strategies to manage breast and nipple pain. In fact, women cite breast and nipple pain as among the most common reasons for breastfeeding cessation. To address this important issue, we developed a breastfeeding self-management (BSM) intervention, based on the Individual and Family Self-Management Theory Framework. In this framework, self-management is conceptualized as a process in which women use knowledge, beliefs, ...[more]

PMID: 30835887

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Project description:INTRODUCTION:Nipple fissure and nipple pain are common complaints among breastfeeding mothers. Studies found that mupirocin was effective in preventing and treating infections of damaged nipple and nipple pain. Acidic fibroblast growth factor (aFGF) plays an important role in wound healing. However, current evidence on the efficacy and safety of mupirocin plus aFGF for nipple fissure and nipple pain in breastfeeding women is inconclusive due to the lack of well-designed randomised controlled trials on this topic. The purpose of this study is to test the hypothesis that mupirocin plus aFGF is more effective than mupirocin alone for nipple fissure and nipple pain in breastfeeding women. METHODS AND ANALYSIS:This study is a randomised, double-blind, single-centre, parallel-group clinical trial. A total of 120 breastfeeding women with nipple fissure and nipple pain will be randomly assigned to either mupirocin plus aFGF group or mupirocin plus placebo group according to a computer-generated random allocation sequence. The treatment period lasts 14 days. The primary outcome is nipple pain intensity measured by the Visual Analogue Scale on day 14 during the treatment period. Secondary outcome measures include time to complete nipple pain relief, changes in the Nipple Trauma Score, time to complete healing of nipple trauma, quality of life measured by the Maternal Postpartum Quality of Life (MAPP-QOL) Questionnaire, the frequency of breast feeding, the rate of breastfeeding discontinuation, weight change in infants and adverse events. ETHICS AND DISSEMINATION:The study has gained approval from the Ethics Review Committee of Tianjin Central Hospital of Gynaecology Obstetrics on 22 January 2018 (approval no. 2018KY001). We plan to publish our research findings in a peer-reviewed academic journal and disseminate these findings in international conferences. This study has been registered with the Chinese Clinical Trial Registry. TRIAL REGISTRATION NUMBER:ChiCTR1800017248.

Project description:OBJECTIVE:To describe the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. DESIGN AND SETTING:Literature search for studies that describe the self-management of cardiac pain in women greater than 18 years of age, managed in community, primary care or outpatient settings, published in English or a Scandinavian language between 1 January 1990 and 24 June 2016 using AMED, CINAHL, ERIC, EMBASE, MEDLINE, Proquest, PsychInfo, the Cochrane Library, Scopus, Swemed+, Web of Science, the Clinical Trials Registry, International Register of Controlled Trials, MetaRegister of Controlled Trials, theses and dissertations, published conference abstracts and relevant websites using GreyNet International, ISI proceedings, BIOSIS and Conference papers index. Two independent reviewers screened using predefined eligibility criteria. Included articles were classified according to study design, pain category, publication year, sample size, per cent women and mean age. INTERVENTIONS:Self-management interventions for cardiac pain or non-intervention studies that described views and perspectives of women who self-managed cardiac pain. PRIMARY AND SECONDARY OUTCOMES MEASURES:Outcomes included those related to knowledge, self-efficacy, function and health-related quality of life. RESULTS:The literature search identified 5940 unique articles, of which 220 were included in the evidence map. Only 22% (n=49) were intervention studies. Sixty-nine per cent (n=151) of the studies described cardiac pain related to obstructive coronary artery disease (CAD), 2% (n=5) non-obstructive CAD and 15% (n=34) postpercutaneous coronary intervention/cardiac surgery. Most were published after 2000, the median sample size was 90 with 25%-100% women and the mean age was 63 years. CONCLUSIONS:Our evidence map suggests that while much is known about the differing presentations of obstructive cardiac pain in middle-aged women, little research focused on young and old women, non-obstructive cardiac pain or self-management interventions to assist women to manage cardiac pain. PROSPERO REGISTRATION NUMBER:CRD42016042806.

Project description:BackgroundThe uptake of Self-Management Support (SMS) among clinicians is suboptimal. To date, few studies have tested knowledge translation (KT) interventions to increase the application of SMS in chiropractic teaching clinics.Study objectiveEvaluate the feasibility of implementing a KT intervention to promote the use of a SMS strategy among chiropractic interns, their supervisors, and individuals with spine pain compared to controls.MethodsMixed methods pilot clustered-clinical trial. Clusters of 16 Patient Management Teams were allocated to a complex KT intervention (online and workshop training). Primary feasibility outcomes for clinicians, interns and patients were rates of recruitment, retention, and adherence to protocol. A nominal group technique and interviews were used to seek end-users' views on the implementation process, and generate possible solutions.ResultsIn total, 16 (84%) clinicians, 65 (26%) interns and 42 patients agreed to participate. All clinicians in the intervention group completed all KT intervention components, 23 interns (85%) completed the online training and 14 interns (51.8%) attended the workshop training. All clinicians in the intervention and seven (78%) in the control group completed all outcome measures at baseline and 6-month follow-up, while 15 (55.6%) and 23 (60.5%) interns in the intervention and control groups completed the questionnaires at baseline and 6-month follow-up, respectively. Among patients, 10 (52.6%) and 12 (52.2%) in the intervention and control groups respectively completed the questionnaires at the end of the study. Based on interview findings, solutions to improve the feasibility of conducting a full trial include: making SMS a part of the internship, changing the time of introducing the study to the interns, and having more training on SMS.ConclusionRecruitment and retention of chiropractic interns and patients for a larger implementation trial in a single outpatient teaching clinic may be challenging.

Dataset Information

Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.

Publications

Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.

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