- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028118
Violence Against Women and Consequences During Climacteric´s Phase (DV)
Domestic and Sexual Violence Against Women: Consequences for Climacteric´s Phase
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05403-900
- Hospital das Clinicas of the Medicine College of the University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Therapy for Women reporting violence
Asking about life experience with violence and Cognitive Behavior Therapy.
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Asking about life experience with violence and Cognitive Behavior Therapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence.
Time Frame: 8 months
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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.
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8 months
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PREVENTION OF DOMESTIC VIOLENCE IN CHILDOOD AND/OR ADOLESCENTS: LESSER PREVALENCE OF COMORBIDITIES IN CLIMACTERIC´S PHASE.
Time Frame: four months
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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. |
four months
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Analyzing among women who suffered violence the comorbidities they suffered in climacteric´s phase.
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence.
Time Frame: 8 months
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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).
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8 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Edmund C Baracat, Titular Prof, University of Sao Paulo General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 180/09 (Other Identifier: EKBB)
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