Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01028118
First received: December 7, 2009
Last updated: April 7, 2010
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Violence
Battered Women
Cognitive Behavior Therapy
 Other: Identifying experience with violence
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Domestic and Sexual Violence Against Women: Consequences for Climacteric´s Phase

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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.

  • PREVENTION OF DOMESTIC VIOLENCE IN CHILDOOD AND/OR ADOLESCENTS: LESSER PREVALENCE OF COMORBIDITIES IN CLIMACTERIC´S PHASE. [ Time Frame: four months ] [ Designated as safety issue: Yes ]

    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.


  • Analyzing among women who suffered violence the comorbidities they suffered in climacteric´s phase. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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:
  • Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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).
Enrollment: 300
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Edmund Chada Baracat, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01028118     History of Changes
Other Study ID Numbers: 180/09 
Study First Received: December 7, 2009
Last Updated: April 7, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 29, 2016