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Evaluation of a Physical Therapy Protocol on Quality of Life Musculoskeletal Pain and Anxiety in Women With Preeclampsia

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ClinicalTrials.gov Identifier: NCT01925508
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Michelle de Souza Rangel Machado, University of Sao Paulo

Brief Summary:
The purpose of this study is to verify that the implementation of a protocol physiotherapy musculoskeletal pain and reduces anxiety and improves quality of life in patients hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed preeclampsia. Where patients will be recruited, answered questionnaires before and after application of physiotherapy protocol.

Condition or disease
Pre-eclampsia or Eclampsia With Pre-existing Hypertension

Detailed Description:
The hypertensive disorders in pregnancy affect approximately 5-8% of pregnant women worldwide, contributing significantly to serious maternal and fetal complications. There are various forms of hypertensive disorders that occur during pregnancy and among them are pre-eclampsia and chronic hypertension with superimposed preeclampsia. These two disorders present with high blood pressure and proteinuria, which leads often to hospitalization of these women. It is believed that with such an accent hospitalization occur in pain conditions that often affect pregnant women. Given these complications, this study aims to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia admitted with respect to blood pressure levels, responses maternal-fetal and perinatal, and measure an expected improvement in quality of life in the reduction of reported pain and anxiety. The study will include the participation of women with preeclampsia and chronic hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may hinder the normal progress of pregnancy. Pregnant women will answer questionnaires about quality of life, anxiety and scales to identify musculoskeletal discomfort. Monitoring will be done both the pregnant woman and the fetus through imaging and laboratory, in addition, pregnant women carry the exercise protocol previously proposed work. This is expected to achieve satisfactory results in the improvement of maternal and fetal hemodynamics in aspects of muscle discomfort and quality of life in a secure way for these women.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Physical Therapy Protocol on Quality of Life, Musculoskeletal Pain and Anxiety in Women With Preeclampsia
Study Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. Quality of life, anxiety and pain in pre-eclampsia [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population will be recruited in the infirmary of the high-risk pregnancy Hostptal das Clinicas of Ribeirao Preto
Criteria

Inclusion Criteria:

  • Pregnant women with gestational age between 24 and 38 weeks
  • Hospitalized in the sector of high-risk pregnancy clinic of the Hospital of Ribeirão Preto with diagnosis of preeclampsia and chronic hypertension with superimposed pre-eclampsia
  • With the absence of other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal

Exclusion Criteria:

  • Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925508


Locations
Brazil
Hospital das Clinicas of Ribeirao Preto
Ribeirao Preto, São Paulo, Brazil, 14040030
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Michelle R Machado, graduation University of Sao Paulo

Publications:
Responsible Party: Michelle de Souza Rangel Machado, Physical therapy, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01925508     History of Changes
Other Study ID Numbers: GO-021083
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Musculoskeletal Pain
Hypertension, Pregnancy-Induced
Pregnancy Complications
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms