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Violence Against Women and Consequences During Climacteric´s Phase (DV)

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ClinicalTrials.gov Identifier: NCT01028118
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : April 8, 2010
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Núcleo de Estudos Sobre Violência e Humanização da Assistencia à Saúde
Information provided by:
University of Sao Paulo General Hospital

Study Description
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Brief Summary:

Objective- Analysis of the health status of women who were or are victims of domestic and sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and Climactery - University of Sao Paulo General Hospital.

To widen the comprehension of the binomial relationship violence-pathologies by professionals/staff who work in health services, offering women in such situation humane, comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic and sexual violence against women employing: prevention, health education and treatment - within the context of health services and public policies.

Methodology - Project Type: Research in Action A- Attention to women in a situation of domestic and sexual violence during climactery; B- Information/Education/Communication (IEC) C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1. Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence; 2. Professional/staff who work in services attending women in sexual and domestic violent situations (health professionals, policemen, civil society) in areas located within the South Regional Health Coordination - SRC. To collect information, a semi structured questionnaire will be employed during seven months in 2009.


Condition or disease Intervention/treatment Phase
Violence Battered Women Cognitive Behavior Therapy Other: Identifying experience with violence Phase 3

Detailed Description:
Trained professionals will work in the regions of: Campo Limpo, M'Boi Mirim, Santo Amaro and neighboring regions, neighborhood in which the Social Vulnerability Index of São Paulo (IPVS) shows high records.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Domestic and Sexual Violence Against Women: Consequences for Climacteric´s Phase
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Therapy for Women reporting violence
Asking about life experience with violence and Cognitive Behavior Therapy.
 Other: Identifying experience with violence
Asking about life experience with violence and Cognitive Behavior Therapy.
Other Names:
  • Violence attention
  • Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence. [ Time Frame: 8 months ]
    Women subjected to sexual violence had significative higher incidence of depression and fibromyalgia that did not respond to classic treatment; after two of Cognitive Behavioral Therapy started to respond to medicine previously employed.

  2. PREVENTION OF DOMESTIC VIOLENCE IN CHILDOOD AND/OR ADOLESCENTS: LESSER PREVALENCE OF COMORBIDITIES IN CLIMACTERIC´S PHASE. [ Time Frame: four months ]

    Analyzing among women who suffered violence in childhood and/or adolescence comorbidities they suffered in climacteric´s phase. We applied a semi-structured questionnaire for women in climactery who suffered domestic violence. We performed descriptive and comparative analysis on violences both groups (violence in childhood and/or adolescence and violence in adulthood) with chronic affections presented in climactery.

    Conclusion: suffering domestic violence during childhood and/or adolescence presents higher prevalence of comorbidities during climacteric´s phase.


  3. Analyzing among women who suffered violence the comorbidities they suffered in climacteric´s phase. [ Time Frame: 3 months ]
    Chronic pathologies in women who suffered violence in childhood/adolescence: Hypertension 47,5%, Diabetes 14,17%, Depression 70,0%;Labyrintitis 36,67%, Fybromialgy 30,83%, Rheumatic disease 25,0%, Ovarian cancer 1,67%, Uterine cancer 3,33%, Disk hernia 13,33%, Allergies 30,83%, Bronchitis 10,83%, Thrombosis 6,67%. Comparing these women to those who suffered violence during adulthood, these women resulted in higher prevalence of Diabetes, Depression, Labyrintitis, Ovarian cancer, Bronchitis/breathing allergies and Thrombosis, when compared to women subjected to violence during adulthood.


Secondary Outcome Measures :
  1. Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence. [ Time Frame: 8 months ]
    Women subjected to violence in any phase of their lives had at least three chronic comorbidities. The correlation between having been subjected to violence and suffering from depression, fibromyalgia or sexual dysfunctions (statistical significant).


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence

Exclusion Criteria:

  • Women who were not victims of domestic and/or sexual violence.
  • Women that were not 40 to 65 years.
Contacts and Locations
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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): NCT01028118


Locations
Brazil
Hospital das Clinicas of the Medicine College of the University of São Paulo
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Núcleo de Estudos Sobre Violência e Humanização da Assistencia à Saúde
Investigators
Principal Investigator: Sandra Dircinha TA Moraes, Post-Doc University of Sao Paulo General Hospital
Study Director: Edmund C Baracat, Titular Prof University of Sao Paulo General Hospital
More Information
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Responsible Party: Edmund Chada Baracat, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01028118     History of Changes
Other Study ID Numbers: 180/09
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: April 8, 2010
Last Verified: March 2009

Keywords provided by University of Sao Paulo General Hospital:
domestic and sexual violence
menopause
professional improvement
social support network