scholarly journals Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022306 ◽  
Author(s):  
Hugo Jario de Almeida Silva ◽  
Caio Alano de Almeida Lins ◽  
Thaiza Teixeira Xavier Nobre ◽  
Vanessa Patrícia Soares de Sousa ◽  
Renata Trajano Jorge Caldas ◽  
...  

IntroductionPhysical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia.MethodsSixty women aged 18–60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment.Ethics and disseminationThis protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins.Trial registration numberNCT03149198.

2017 ◽  
Vol 103 (5) ◽  
pp. F403-F407 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Chanchai Traivaree ◽  
Sangkae Chamnanvanakij ◽  
Pimchitr Rungtragoolchai ◽  
Yawana Thanapat ◽  
...  

ObjectiveThis study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent.DesignA single-centre open-label randomised controlled study.SettingAntenatal care clinics at Phramongkutklao Hospital, Thailand.Patients234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study.InterventionsThe participants were randomly assigned to read either the SIDCER ICF or the conventional ICF.Main outcome measuresThe participants’ understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25).Results72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF group achieved the primary endpoint (relative risk (RR)=1.212, 95% CI 1.005 to 1.462, p=0.041). The superiority of the SIDCER ICF over the conventional ICF was significant, particularly among the participants whose education was at the high school level or below (63.5% vs 44.1%, RR=1.441, 95% CI 1.022 to 2.030, p=0.031).ConclusionsThe SIDCER ICF methodology is applicable to neonatal research requiring maternal consent. The SIDCER ICF significantly improved the understanding of pregnant women, particularly among those with lower levels of education. The present study confirms the value of the SIDCER ICF methodology in research involving individuals with a limited academic background.


2015 ◽  
Vol 72 (4) ◽  
pp. 413-421 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Supanimit Teekachunhatean ◽  
Nutthiya Hanprasertpong ◽  
Junjira Laothavorn ◽  
Kesara Na-Bangchang ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029530
Author(s):  
Nut Koonrungsesomboon ◽  
Chanchai Traivaree ◽  
Charnunnut Tiyapsane ◽  
Juntra Karbwang

ObjectiveThis study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.DesignA prospective, randomized, controlled design.SettingPaediatric Outpatients Department, Phramongkutklao Hospital, Thailand.Participants210 parents of children with thalassemia (age=35.6 ± 13.1 years).InterventionsThe parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.Primary and secondary outcome measuresParental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.ResultsForty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).ConclusionsThe SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.


2017 ◽  
Vol 3 (1) ◽  
pp. 199-203
Author(s):  
Rini Indrati ◽  
Meita Shinta Fatikhatul Laila ◽  
Andrey Nino Kurniawan

Background: The implementation of informed consent at Radiology department of Sukoharjo Hospital was conducted by administrative officer and radiographer. The officer explained the preparation of pyelographic intra-venous examination to the patient then the patient was asked to fill out and sign the informed consent form. According to the Indonesian Medical Council and Regulation of the Minister of Health of Indonesia, the delivery of informed consent is carried out by doctors. The doctor explains all the information contained in the contents of informed consent before taking any medical action. The purpose of this research is to know the implementation of informed consent done in the radiology department and patient understanding of the contents of the informed consent form.Methods: The type of this research is descriptive qualitative research with the observational approach. Data were collected in March-June 2017 by observational of informed consent and interviews of 30 patients who will conduct intra vena pyelographic examination. Data analyzed by descriptively.Results: The results showed that the provision of informed consent to intravenous pyelographic examination patient at Sukoharjo Hospital was performed by administration officer and radiographer before conducting the examination. The patient's understanding of the contents of informed consent has not been in accordance with the content of the informed consent form because the information submitted by the radiologist only concerning the preparation of intravenous examination of pyelography does not include examination procedures, objectives, risks, complications, diagnoses, prognoses, alternative other measures and risks, and costs.Conclusions: In radiology department of Sukoharjo hospital at Intravenapyelography patient informed consent delivered by administrative officers and radiographer. Patients understanding the content of informed consent


Author(s):  
Susan Waters ◽  
Melody Carswell ◽  
Eric Stephens ◽  
Ada Sue Selwit

How information is presented in an informed consent form can mean the difference between success and failure in a research project.


Author(s):  
E Villamañán ◽  
I Jiménez-Nácher ◽  
P Gómez-Salcedo ◽  
E Wagner ◽  
M Freire ◽  
...  

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