Study on Violence Against Vulnerable Women and Optimizing Support Services (ENVVOL)
8. července 2026 aktualizováno: Centre Hospitalier Universitaire de Nīmes
A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services
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).
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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).
Typ studie
Pozorovací
Zápis (Odhadovaný)
70
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sylvie RIPART, Dr.
- Telefonní číslo: +336.87.70.13.02
- E-mail: sylvie.ripart@chu-nimes.fr
Studijní záloha kontaktů
- Jméno: Clémence CASARA, Midwife
- Telefonní číslo: +334.66.68.67.52
- E-mail: clemence.casara@chu-nimes.fr
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improvements in quality of life
Časové okno: 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
|
|
Improvements in quality of life
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improvements in quality of life at 3 months
Časové okno: 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
|
|
Improvements in quality of life at 3 months
Časové okno: 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
|
|
Difference in sleep quality at 3 and 6 months compared to baseline.
Časové okno: 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
|
|
Difference in sleep quality at 3 and 6 months compared to baseline.
Časové okno: 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
|
|
Difference in sleep quality at 3 and 6 months compared to baseline.
Časové okno: 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
|
|
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At 6 months
|
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
|
At 6 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. září 2026
Primární dokončení (Odhadovaný)
15. listopadu 2026
Dokončení studie (Odhadovaný)
15. května 2027
Termíny zápisu do studia
První předloženo
8. července 2026
První předloženo, které splnilo kritéria kontroly kvality
8. července 2026
První zveřejněno (Aktuální)
14. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. července 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- APITHEM/2025/SR-01
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NE
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .