Klinische proef op Misbruik van vrouwen, Echtgenoot misbruik, Vrouwelijke genitale verminking, Misbruik, seksueel - Register voor klinische proeven

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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).

Studietype

Observationeel

Inschrijving (Geschat)

70

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Sylvie RIPART, Dr.
Telefoonnummer: +336.87.70.13.02
E-mail: sylvie.ripart@chu-nimes.fr

Studie Contact Back-up

Naam: Clémence CASARA, Midwife
Telefoonnummer: +334.66.68.67.52
E-mail: clemence.casara@chu-nimes.fr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in quality of life Tijdsspanne: 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 Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 september 2026

Primaire voltooiing (Geschat)

15 november 2026

Studie voltooiing (Geschat)

15 mei 2027

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

APITHEM/2025/SR-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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

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