A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Improvements in quality of life
研究概览
简要总结
Sexual and gender-based violence in France primarily affects women, who make up 88% of victims, with 670,000 affected annually. Many suffer abuse from partners, including 94,000 rape cases, and minors are heavily impacted. Despite frequent emergency visits, medical follow-up is inconsistent, and these violences significantly reduce women's healthy life expectancy. The study aims to assess quality of life improvements six months after multidisciplinary care in specialized centers like "La Maison des Femmes" (The Women's House).
详细描述
Gender-based and sexual violence in France primarily affects women, who account for 88% of victims. Each year, around 670,000 women experience this violence, including 213,000 at the hands of their current or former partner. Among them, 94,000 are victims of rape or attempted rape-that's one rape every 8 minutes. This violence particularly affects minors, with 59% of men accused of having victims under the age of 18. Yet only 1 in 5 victims files a complaint. In 2023, 134 women were killed by their spouse or former spouse. In addition to the direct victims, the children in the family are often co-victims, exposed to violence and suffering from serious psychological and behavioral consequences. In 2024, more than 450,000 victims of physical violence and 122,600 victims of sexual violence were recorded, a situation that is particularly alarming among women in vulnerable situations (minors, migrants, and the homeless). Some migrant women undergo female genital mutilation, resulting in lasting trauma. In 2010, the number of adult women who had undergone female genital mutilation (FGM) in France was estimated at more than 124,000. Violence has serious impacts on physical and mental health: post-traumatic stress, sleep disorders, depression, risky behaviors, as well as an increased incidence of certain diseases (cardiovascular diseases, cancers, gynecological conditions). Pregnancy is often an aggravating factor in domestic violence, with increased risks for both the mother and the child. Children exposed to domestic violence also suffer from various problems (developmental delays, behavioral disorders, and impaired self-esteem). On average, 3 femicides per day are recorded, whether direct or indirect.
Despite increased use of emergency rooms, medical follow-up for victims remains inconsistent. According to the WHO, this violence reduces women's healthy life expectancy by 1 to 4 years. Beyond individual suffering, this violence carries a heavy social and economic cost, affecting professional life, the ability to care for themselves and their children, and often leading to isolation. The main aim of this study is to assess improvements in quality of life at 6 months (baseline vs. 6-month comparison) following multidisciplinary care for vulnerable women or victims of violence referred to a specialized facility such as the Maison Des Femmes (MDF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women receiving care at the MDF in the Gard department;
- •Women in situations of vulnerability and violence
- •Women who agree to participate in the study and have signed the consent form;
- •Non-French-speaking women who can be assisted in understanding through the midwife's intervention and telephone interpretation
- •Note: Pregnant and breastfeeding women may be included. Indeed, pregnancy is a trigger or aggravating factor for domestic violence and can further exacerbate the precarious situation of women seeking services at the MDF.
- •Article L1121-1 of the Public Health Code (CSP) and Decree No. 2016-1537 of November 16, 2016, stipulate that biomedical research must protect vulnerable individuals, including pregnant women, but authorize clinical trials if the benefits outweigh the risks.
- •Note: Patients who are not covered by social security will be recruited in accordance with Article L1121-8-1 of the Public Health Code*
- •Individuals who are not enrolled in a social security program or who are not beneficiaries of such a program may be recruited to participate in non-interventional research.
- •As an exception, the Human Subjects Protection Committee may authorize a person who is not enrolled in or a beneficiary of a social security system to participate in research referred to in paragraphs 1 or 2 of Article L. 1121-
- •This authorization must be justified.
排除标准
- •All persons under guardianship or conservatorship
- •All persons incapable of giving consent
结局指标
主要结局
Improvements in quality of life
时间窗: Baseline
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Improvements in quality of life
时间窗: At 6 months
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Change in quality of life
时间窗: Baseline
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Change in quality of life
时间窗: At 6 months
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
次要结局
- Improvements in quality of life at 3 months(Baseline)
- Improvements in quality of life at 3 months(At 3 months)
- Difference in sleep quality at 3 and 6 months compared to baseline.(Baseline)
- Difference in sleep quality at 3 and 6 months compared to baseline.(At 3 months)
- Difference in sleep quality at 3 and 6 months compared to baseline.(At 6 months)
- Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.(Baseline)
- Types of treatments and care pathways used, and assessment of patient adherence(Baseline)
- Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.(At 3 months)
- Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.(At 6 months)
- Types and frequencies of various forms of vulnerability and violence against women(Baseline)
- Types and frequencies of various forms of vulnerability and violence against women(At 3 months)
- Types and frequencies of various forms of vulnerability and violence against women(At 6 months)
- Types of treatments and care pathways used, and assessment of patient adherence(At 3 months)
- Types of treatments and care pathways used, and assessment of patient adherence(At 6 months)
- Change in quality of life at 3 months(Baseline)
- Change in quality of life at 3 months(At 3 months)
- Change in sleep quality at 3 and 6 months compared to baseline.(Baseline)
- Change in sleep quality at 3 and 6 months compared to baseline.(At 3 months)
- Change in sleep quality at 3 and 6 months compared to baseline.(At 6 months)