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Effect of LED therapy for the treatment nipple fissures: Study protocol for a randomized controlled trial.

ABSTRACT: INTRODUCTION:Poor positioning of the child in relation to the breast and improper suckling are the main causes of nipple fissure. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses, and silicone nipple shields. Studies involving light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process, and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures. AIM:The principal objective of the proposed study is to evaluate the effectiveness of LED therapy for the treatment of nipple fissures in postpartum mothers. MATERIALS AND METHODS:One hundred patients treated with a medical diagnosis of bilateral nipple trauma classified as nipple fissures or cracks will participate in the study, randomized into 2 groups: The control group will receive orientation regarding breast care and adequate breastfeeding techniques. The experimental group will receive the same orientation and phototherapy sessions using a device developed especially for the treatment of nipple trauma. Both groups will be followed up for 6 consecutive weeks.

SUBMITTER: Campos TM

PROVIDER: S-EPMC6203513 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Effect of LED therapy for the treatment nipple fissures: Study protocol for a randomized controlled trial.

Campos Thalita Molinos TM Dos Santos Traverzim Maria Aparecida MA Sobral Ana Paula Taboada APT Bussadori Sandra Kalil SK Fernandes Kristianne Santos Porta KSP Motta Lara Jansiski LJ Makabe Sergio S

Medicine 20181001 41

<h4>Introduction</h4>Poor positioning of the child in relation to the breast and improper suckling are the main causes of nipple fissure. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses, and silicone nipple shields. Studies involving light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair proc ...[more]

PMID: 30313028

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Project description:BACKGROUND:Our goal is to improve psychosocial and spiritual care outcomes for elderly patients with cancer by optimizing an intervention focused on dignity conservation tasks such as settling relationships, sharing words of love, and preparing a legacy document. These tasks are central needs for elderly patients with cancer. Dignity therapy (DT) has clear feasibility but inconsistent efficacy. DT could be led by nurses or chaplains, the 2 disciplines within palliative care that may be most available to provide this intervention; however, it remains unclear how best it can work in real-life settings. OBJECTIVE:We propose a randomized clinical trial whose aims are to (1) compare groups receiving usual palliative care for elderly patients with cancer or usual palliative care with DT for effects on (a) patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness); and (b) processes of delivering palliative spiritual care services (satisfaction and unmet spiritual needs); and (2) explore the influence of physical symptoms and spiritual distress on the outcome effects (dignity impact and existential tasks) of usual palliative care and nurse- or chaplain-led DT. We hypothesize that, controlling for pretest scores, each of the DT groups will have higher scores on the dignity impact and existential task measures than the usual care group; each of the DT groups will have better peaceful awareness and treatment preference more consistent with their cancer prognosis than the usual care group. We also hypothesize that physical symptoms and spiritual distress will significantly affect intervention effects. METHODS:We are conducting a 3-arm, pre- and posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care and usual outpatient palliative care along with either nurse- or chaplain-led DT on patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). We will include 560 elderly patients with cancer from 6 outpatient palliative care services across the United States. Using multilevel analysis with site, provider (nurse, chaplain), and time (step) included in the model, we will compare usual care and DT groups for effects on patient outcomes and spiritual care processes and determine the moderating effects of physical symptoms and spiritual distress. RESULTS:The funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021. CONCLUSIONS:This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients. TRIAL REGISTRATION:ClinicalTrials.gov NCT03209440; https://clinicaltrials.gov/ct2/show/NCT03209440. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12213.

Project description:BACKGROUND:The current treatment paradigm for type 2 diabetes mellitus (T2D) typically involves use of multiple medications to lower glucose levels in hope of reducing long-term complications. However, such treatment does not necessarily address the underlying pathophysiology of the disease and very few patients achieve partial, complete, or prolonged remission of T2D after diagnosis. The therapeutic potential of nutrition has been highlighted recently based on results of clinical trials reporting remission of T2D with targeted dietary approaches. During the initial phase of such interventions that restrict carbohydrates and/or induce rapid weight loss, hypoglycemia presents a notable risk to patients. We therefore hypothesized that delivering very low-carbohydrate, low-calorie therapeutic nutrition through community pharmacies would be an innovative strategy to facilitate lowering of glycated hemoglobin (A1C) while safely reducing the use of glucose-lowering medications in T2D. METHODS:A community-based randomized controlled trial that is pragmatic in nature, following a parallel-group design will be conducted (N?=?200). Participants will have an equal chance of being randomized to either a pharmacist-led, therapeutic carbohydrate restricted (Pharm-TCR) diet or guideline-based treatment as usual (TAU). Pharm-TCR involves a 12-week very low carbohydrate, calorie-restricted commercial diet plan led by pharmacists and lifestyle coaches with pharmacists responsible for managing medications in collaboration with the participants' family physicians. Main inclusion criteria are diagnosis of T2D, currently treated with glucose-lowering medications, age 30-75 years, and body mass index ??30. The primary outcome is a binary measure of use of glucose-lowering medication. Secondary outcomes include A1C, anthropometrics and clinical blood markers. DISCUSSION:There are inherent risks involved if patients with T2D who take glucose-lowering medications follow very low carbohydrate diets. This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03181165. Registered on 8 June 2017.

Project description:BackgroundThe risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese.MethodsThe Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial.DiscussionThis paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI.Trial registrationwww.clinicaltrials.gov; NCT02175641, registered 24 June 2014.

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Effect of LED therapy for the treatment nipple fissures: Study protocol for a randomized controlled trial.

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Effect of LED therapy for the treatment nipple fissures: Study protocol for a randomized controlled trial.

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