Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2012 | ||||
| Last Updated Date | April 11, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01576978 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman | ||||
| Official Title ICMJE | Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman | ||||
| Brief Summary | The aim of this study is to identify evaluate the effectiveness of stretching exercises of Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten weeks, once a week group B postural follow the guidelines recommended for the treatment of these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic pain in order to differentiate them. A descriptive statistical analysis of univariate and bivariate distributions will be made through frequency and graphical representation. The association between the variables will be tested by statistical tests: [chi-square (X ²)], Fisher's exact test, Student's t test or Mann-Whitney, [Student's t test to compare means], ANOVA for the analysis of effects between the groups. [The significance level is predetermined to 5%]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the database created . |
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| Detailed Description | OBJECTIVES General Purpose Identify the percentage of pregnant women with spinal postural pains in antenatal services in the city of Paulinia and evaluate the effectiveness of the Classical Yoga exercises for the lumbar and posterior pelvic pains in the group of women who will do the exercises, as well as developments pain intensity in patients with and without exercise. Specific Objectives
ASSUMPTIONS
SUBJECTS AND METHODS: Design Identification of the percentage of pregnant women with postural pains in the spine in health units and clinical trial, prospective, randomized and controlled. Sample Size To calculate the sample size was calculated as the average change in pain intensity referred to the global active stretching group at the end of the first and eighth week of treatment. The mean and standard deviation of the intensity of pain at the end of the first week was 4.88 SD 3.056 and at the end of the eighth week 0.85 SD 1.875 (Martins & PINTO E SILVA, 2005 b) The assumption is that the effect of treatment with yoga is similar to that found with the global active stretching. Considering a significance level of 5%, a test power of 80%, based on the mean difference reported and adopting the paired t-test, the smallest sample size required is n = 7 women in each group. However, for purposes of research and publication is suggested to adopt an "n" greater than 30 women per group. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: hatha yoga
The women's group of Yoga will participate in ten week sessions of Yoga once a week for an hour. The sessions will be taught by instructor of Hatha Yoga. For the intervention were chosen 37 postures, three breathing exercises. The sessions were divided into three stages: quieting the mind , breathing rate and the heating of the main joints, postures and breathing exercises, meditation and relaxation. At the beginning and end of each session, we evaluated the pain intensity.Pregnant women in the control group Postural orientations will receive a booklet containing guidelines postural figures and explanatory text on some possible changes in the curvatures of the spine during pregnancy suggestions for positioning of the spine for daily activities, lying postures, sitting and standing. After ten weeks the two groups will be scheduled for the final collection of data. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01576978 | ||||
| Other Study ID Numbers ICMJE | w7tgp7jt | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Roseny Flávia Martins, University of Campinas, Brazil | ||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Campinas, Brazil | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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