NCT01028118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
Last Updated

April 8, 2010

Status Verified

March 1, 2009

Enrollment Period

2 months

First QC Date

December 7, 2009

Last Update Submit

April 7, 2010

Conditions

Keywords

domestic and sexual violencemenopauseprofessional improvementsocial support network

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence.

    8 months

Study Arms (1)

Therapy for Women reporting violence

OTHER

Asking about life experience with violence and Cognitive Behavior Therapy.

Other: Identifying experience with violence

Interventions

Asking about life experience with violence and Cognitive Behavior Therapy.

Also known as: Violence attention, Therapy
Therapy for Women reporting violence

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women who were not victims of domestic and/or sexual violence.
  • Women that were not 40 to 65 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas of the Medicine College of the University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Sandra Dircinha TA Moraes, Post-Doc

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR
  • Edmund C Baracat, Titular Prof

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

April 8, 2010

Record last verified: 2009-03

Locations