Violence Against Women and Consequences During Climacteric´s Phase

Violence Clinical Trial

— DV  

Official title:

Domestic and Sexual Violence Against Women: Consequences for Climacteric´s Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028118
• Other study ID #: 180/09
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2009
• Last updated: April 7, 2010
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: March 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Battered Women
• Cognitive Behavior Therapy
• Violence

Intervention

Other:
• Identifying experience with violence
Asking about life experience with violence and Cognitive Behavior Therapy.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas of the Medicine College of the University of São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Núcleo de Estudos Sobre Violência e Humanização da Assistencia à Saúde

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence.	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.	8 months	Yes
Primary	PREVENTION OF DOMESTIC VIOLENCE IN CHILDOOD AND/OR ADOLESCENTS: LESSER PREVALENCE OF COMORBIDITIES IN CLIMACTERIC´S PHASE.	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	Yes
Primary	Analyzing among women who suffered violence the comorbidities they suffered in climacteric´s phase.	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.	3 months	Yes
Secondary	Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence.	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).	8 months	Yes