虐待妇女、虐待配偶、女性外阴残割、虐待、性的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

尚未招聘

条件

详细说明

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).

研究类型

观察性的

注册 (估计的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Sylvie RIPART, Dr.
电话号码：+336.87.70.13.02
邮箱：sylvie.ripart@chu-nimes.fr

研究联系人备份

姓名：Clémence CASARA, Midwife
电话号码：+334.66.68.67.52
邮箱：clemence.casara@chu-nimes.fr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Women, victims of domestic violence frequenting the Maison des Femmes (Women's House) in Nîmes. La Maison Des Femmes serves many migrant women whose health has deteriorated due to the hardships in their home countries, their migration journey, and upon arrival in France. Barriers to accessing care are linked to administrative, legal, linguistic, and cultural obstacles, as well as economic circumstances. They may come to the center on their own or be referred by a healthcare provider, an organization, a Medical and Psychological Center or Medical and Social Center, law enforcement, healthcare professionals, or anyone else who is aware of the existence of the facility. It has been open since January 2025 and has served 146 patients, scheduled 498 appointments (356 of which were kept) conducted 291 consultations, and provided 65 outpatient hospitalizations. It supports women from various backgrounds, many of whom are in vulnerable situations and/or have experienced violence.

描述

Inclusion criteria :

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. 1121-1. This authorization must be justified.

Exclusion Criteria:

All persons under guardianship or conservatorship
All persons incapable of giving consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in quality of life 大体时间：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"	Baseline
Change in quality of life 大体时间：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"	At 6 months

次要结果测量

结果测量	措施说明	大体时间
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. 大体时间：Baseline	The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.	Baseline
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. 大体时间：At 3 months	The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.	At 3 months
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. 大体时间：At 6 months	The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.	At 6 months
Types and frequencies of various forms of vulnerability and violence against women 大体时间：Baseline	Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.	Baseline
Types and frequencies of various forms of vulnerability and violence against women 大体时间：At 3 months	Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.	At 3 months
Types and frequencies of various forms of vulnerability and violence against women 大体时间：At 6 months	Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.	At 6 months
Types of treatments and care pathways used, and assessment of patient adherence 大体时间：Baseline	Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.	Baseline
Types of treatments and care pathways used, and assessment of patient adherence 大体时间：At 3 months	Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.	At 3 months
Types of treatments and care pathways used, and assessment of patient adherence 大体时间：At 6 months	Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.	At 6 months
Change in quality of life at 3 months 大体时间：Baseline	Difference in quality of life between baseline and 3 months, as measured by 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"	Baseline
Change in quality of life at 3 months 大体时间：At 3 months	Difference in quality of life between baseline and 3 months, as measured by 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"	At 3 months
Change in sleep quality at 3 and 6 months compared to baseline. 大体时间：Baseline	The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.	Baseline
Change in sleep quality at 3 and 6 months compared to baseline. 大体时间：At 3 months	The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.	At 3 months
Change in sleep quality at 3 and 6 months compared to baseline. 大体时间：At 6 months	The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.	At 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Nīmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2026年11月15日

研究完成 (估计的)

2027年5月15日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

Study on Violence Against Vulnerable Women and Optimizing Support Services (ENVVOL)

A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services