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Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

ABSTRACT: Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.To evaluate the effects of LED photobiomodulation on analgesia during labor.In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into 2 groups: intervention group [analgesia with LED therapy (n?=?30)] and control group [analgesia with bath therapy (n?=?30)]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, that is, before the intervention. In both the groups, the procedures will last 10?minutes and will be performed at 3 time points during labor: during cervical dilation of 4 to 5?cm, 6 to 7?cm, and 8 to 9?cm. At all 3 time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points.The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.

SUBMITTER: Traverzim MADS

PROVIDER: S-EPMC6023678 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

Traverzim Maria Aparecida Dos Santos MADS Makabe Sergio S Silva Daniela Fátima Teixeira DFT Pavani Christiane C Bussadori Sandra Kalil SK Fernandes Kristianne Santos Porta KSP Motta Lara Jansiski LJ

Medicine 20180601 25

<h4>Background</h4>Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to ph ...[more]

PMID: 29924010

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Project description:INTRODUCTION:The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing. In this context, procedures, such as cryolipolysis, ultracavitation, photobiomodulation (PBM) and other techniques have been proposed. Some studies have shown that PBM can be used in body contouring. However, there is no standardisation of the protocol. More than that, as in other techniques for reducing adipose tissue, the availability of triacylglycerol may affect the lipid profile in the blood, bringing consequences to the general health of an individual. This work will aim to compare the light wavelengths when using PBM as a technique for reducing the abdominal waist circumference, while also evaluating the efficacy of the method. Changes in the lipid profile in the blood, with a long-term follow-up, will also be appraised. METHODS AND ANALYSIS:This will be a controlled, randomised, double-blind, single-centred clinical trial. 174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups: Group A-RED PBM; Group B-INFRARED PBM; Group C-PLACEBO (Sham) treatment. The treatments will consist of eight sessions, two times a week, for 4 weeks. At each session, the participants will receive 30 minutes PBM (using a radiant exposure of 127 J/cm2), with an abdominal strap containing 4 LED clusters, with 72 devices each, following the indication of randomisation. All of the groups will receive 30 min of Aussie Current, at 4 kHz, modulated at 10 Hz, 40-60 mA. The main outcome of this study will be waist circumference reduction. The secondary variables will be anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem. The analyses will be performed at four stages of the research, D0, end of the eighth session (D30), 15 days after the last session (FU15), 90 days after the last session (FU90) and 180 days after the last session (FU180). ETHICS AND DISSEMINATION:The Ethics Committee of the Nove de Julho University, Brazil, approved the modified version of this project under No. 3414146 on 26 June 2019. This study is not yet recruiting. The results obtained will be published in a peer-reviewed journal in the related field. TRIAL REGISTRATION NUMBER:Brazilian Registry of Clinical Trials-ReBec (RBR-9bwxcx).

Project description:BACKGROUND:The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. However, the intense pain during the functional exercise involved has always been a challenge for both patients and health care professionals. The aim of this study is to test the analgesic effect of a mixture of nitrous oxide/oxygeb (1:1) inhalation for patients who are doing functional exercise 1 month after total knee arthroplasty. METHODS/DESIGN:This double-blind, randomized, placebo-controlled study will be implemented in the Rehabilitation Department in the General Hospital of Ningxia Medical University. Patients aged between 50 and 75 years who underwent a primary unilateral total knee arthroplasty are eligible for inclusion. The key exclusion criteria include: epilepsy, pulmonary embolism, intestinal obstruction, aerothorax. The treatment group (A) will receive a pre-prepared nitrous oxide/oxygen mixture plus conventional treatment (no analgesics), and the control group (B) will receive oxygen plus conventional treatment (no analgesics). Patients, physicians, therapists, and data collectors are all blind to the experiment. Assessments will be taken immediately after functional exercise begins (T0), 5 min (T1) after functional exercise begins, and 5 min after functional exercise has finished (T2). Patients will be randomly allocated between a treatment group (A) and a control group (B) in a ratio of 1:1. Primary outcome, including pain severity in the procedure, will be taken for each group. Secondary outcomes include blood pressure, heart rate, oxygen saturation, side effects, knee joint range of motion, Knee Society Score (KSS), rescue analgesia need, and satisfaction from both therapists and patients. DISCUSSION:This study will focus on exploring a fast and efficient analgesic for patients who are doing functional exercise after total knee arthroplasty. Our previous studies suggested that the prefixed nitrous oxide/oxygen mixture was an efficacious analgesic for the management of burn-dressing pain and breakthrough cancer pain. The results of this study should provide a more in-depth insight into the effects of this analgesic method. If this treatment proves successful, it could be implemented widely for patients doing functional exercise in the rehabilitation department. TRIAL REGISTRATION:ChiCTR-INR-17012891 . Registered on 6 October 2017.

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Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

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Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

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