Questionnaire to Study Violence Against Women in the Climateric's Phase.
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 14, 2010 | ||||||||
| Last Updated Date | January 27, 2011 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of comorbidities present in the climacteric phase and intensity of symptoms in women victims of domestic violence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
DOMESTIC VIOLENCE IN CHILDOOD AND/OR ADOLESCENTS:PREVALENCE OF COMORBIDITIES IN CLIMACTERY. [ 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%, Tenosinovitis 3,33%, Fybromialgy 30,83%, Rheumatic disease 25,0%, Cancers 7,5%), Systemic Lupus Erythematosus 2,5%, Disk hernia 13,33%, Allergies 30,83%, Bronchitis 10,83%, Varices 32,5%; Thrombosis 6,67%. Comparing these women to those who suffered violence during adulthood, these women have more commorbities than those.Women do not perceive the traumas they suffer due to the extreme banalization of violence. |
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| Change History | Complete list of historical versions of study NCT01158768 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Questionnaire to Study Violence Against Women in the Climateric's Phase. | ||||||||
| Official Title ICMJE | Questionnaire to Study Impacts in the Health of the Woman in the Climateric's Phase, Victim of Domestic and/or Sexual Violence | ||||||||
| Brief Summary | Objectives - To construct and validate a questionnaire evaluating violence suffered by women during any phase of their lives and health repercussions during climactery. Method: A controlled study with the application of a questionnaire at the Outpatient Clinics for Endocrine Gynecology and Climactery of the University Hospital (Hospital das Clínicas) of the Medicine College of the University of São Paulo (FMUSP), Brazil, performed during 2009 for 124 women aged between 40 and 65 years, who were victims of domestic and/or sexual violence, distributed in three groups regarding the phase in which their experience with violence occurred: 1. Violence exclusively during childhood/adolescence; 2. During adulthood; 3. Throughout all phases. The instrument encompasses 13 key questions and 21 sub items evaluating: 1. Place of residence and who the woman lives with; 2. Start, frequency and type of violence; 3. Search for health assistance and report of the violence; 4. Violence and number of affections; 5. Violence and Menopausal Kupermann Index (IMK). Results: The instrument presented Cronbach Alpha=0.82, reliability among examiners (+0,80), and good possibility to be reproduced. Average age of the women was 55,8 years (±6,6), menopause at -45,4 years in average, in the control Group (GC) it was 48,1 years; first sexual intercourse 19,5 years (GC = 21,0); menarche 13,1 years, and average BMI (Body Mass Index) 28,5 (±2,8), similar to the GC, but frequent violence during adulthood showed a BMI of 30,0 (±2,8). Women who were submitted to violence exclusively: during childhood 14,5%; adolescence 1,6%; adulthood 41,9%, during all phases of their lives 42,0%. Women subjected to violence during childhood/adolescence (58,1%) presented an average of 5,1 affections; during adulthood, 4,6 and 4,4 for both phases. Sexual violence (43,5%) and other types of violence both present average affections (4,60) but represent a significative impairment of sexual life. There were significative associations between suffering any type of violence during all phases of their lives, sexual violence during any phase of their lives and a serious IMK. Among those women, 80,6% did not search health services due to the violence suffered. Conclusion: The questionnaire presents good internal consistency and a validated construction, can be easily reproduced and is indicated to evaluate the consequences of domestic and/or sexual violence on women´s health during climactery. |
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| Detailed Description | The score for each dominium varied from 0 to 100 and the higher the score the worst is past experience with mistreats. Scores for each dominium were then compared to groups of patients previously defined.We employed statistic tests for two independent samples (Mann-Whitney). For all the tests we fixed in 0,05 or 5% the level of rejection of the null hypothesis. In order to characterize the study sample, patients were defined according to characteristics including anthropometric, climacteric and lifestyle features. Quantitative variables were described according to the average and the respective patter deviation, median and minimum and maximum values. Qualitative variables were described by simple percentages. Questionnaire designed to analyze "Impacts on Women's Health during the climactery phase if victim of domestic or sexual violence" by Moraes & Fonseca, 2009 This is a two part set. If the woman suffered violence during childhood and;or adolescence, she will answer the Portuguese version of Childhood Trauma Questionnaire, which is a self applied instrument for adolescents and adults investigating history of abuse and negligence during childhood and adolescence. The instrument was translated, adapted and validated the questionnaire contents for a Portuguese version with the original name of "Questionário Sobre Traumas na Infância" (Childhood Trauma Questionnaire) (annex 1), by Grassi-Oliveira R et al, 2006. If the woman was subjected to violence during her life, especially during adulthood, she will answer the questionnaire on "Impacts on Women's Health during Climactery Phase, if victim of domestic or sexual violence", elaborated and validated by Moares &¨Fonseca, 2009. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Women (during the ages of 40 to 65 years) 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 during 2009. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Violence, Comorbidity | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 288 | ||||||||
| Completion Date | August 2009 | ||||||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 40 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01158768 | ||||||||
| Other Study ID Numbers ICMJE | 180/09.1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Angela Maggio da Fonseca, University of Sao Paulo General Hospital | ||||||||
| Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo General Hospital | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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