ComorbidityNCT01158768
Questionnaire to Study Violence Against Women in the Climateric's Phase.
An observational study of Comorbidity and Domestic Violence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comorbidity, Domestic Violence, Sexual Abuse
- How many people
- 288 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence
Who cannot join
- Women who were not victims of domestic and/or sexual violence.
- Women that were not 40 to 65 years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas of the Medicine College of the University of São Paulo
São Paulo, São Paulo
About this study
Official title: Questionnaire to Study Impacts in the Health of the Woman in the Climateric's Phase, Victim of Domestic and/or Sexual Violence
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).
Read more
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.
Read the 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.
- Conditions
- Comorbidity, Domestic Violence, Sexual Abuse
- Keywords
- domestic violence in childhood/adolescence, comorbidities, climactery, domestic violence against women, trauma questionnaire, Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Violence, Comorbidity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of comorbidities present in the climacteric phase and intensity of symptoms in women victims of domestic violence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComorbidityStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Núcleo de Estudos Sobre Violência e Humanização da Assistencia à Saúde
- Investigators
- Angela M Fonseca, Assoc Prof, Study director, University of Sao Paulo General HospitalSandra Dircinha TA Moraes, Post-Doc, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158768
- Sponsor's protocol ID
- 180/09.1
- Status last verified
- Mar 2009
- First submitted
- 14 May 2010
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire to Study Impacts in the Health of the Woman in the Climateric's Phase, Victim of Domestic and/or Sexual Violence
- ClinicalTrials.gov ID
- NCT01158768
- Acronym / sponsor ID
- 180/09.1
- Conditions
- Comorbidity, Domestic Violence, Sexual Abuse
- Keywords
- domestic violence in childhood/adolescence, comorbidities, climactery, domestic violence against women, trauma questionnaire, Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Núcleo de Estudos Sobre Violência e Humanização da Assistencia à Saúde
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Violence, Comorbidity | – | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence
Key exclusion criteria (2 listed)
- Women who were not victims of domestic and/or sexual violence.
- Women that were not 40 to 65 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of comorbidities present in the climacteric phase and intensity of symptoms in women victims of domestic violence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Fonseca, Assoc Prof study director
University of Sao Paulo General Hospital
Sandra Dircinha TA Moraes, Post-Doc principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidity and Domestic Violence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of comorbidities present in the climacteric phase and intensity of symptoms in women victims of domestic violence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.