NCT Number: NCT07701629
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).
Trial opening soon.
Get Notified18 year and older
Female
Observational
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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*
Exclusion criteria
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Time frame: At 3 months
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Time frame: At 6 months
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Time frame: Baseline
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Time frame: At 3 months
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Time frame: At 6 months
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Contact information is provided by the study sponsor or research team.
Clémence CASARA, Midwife
CONTACT
Sylvie RIPART, Dr.
CONTACT
Centre Hospitalier Universitaire de Nīmes
Other
A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services
Acronym: ENVVOL
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