Kliininen tutkimus Naisen hyväksikäyttö, Puolison hyväksikäyttö, Naisten sukupuolielinten silpominen, Pahoinpitely, Seksuaalinen - Kliinisten tutkimusten rekisteri

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Yksityiskohtainen kuvaus

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).

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

70

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Nimi: Sylvie RIPART, Dr.
Puhelinnumero: +336.87.70.13.02
Sähköposti: sylvie.ripart@chu-nimes.fr

Tutki yhteystietojen varmuuskopiointi

Nimi: Clémence CASARA, Midwife
Puhelinnumero: +334.66.68.67.52
Sähköposti: clemence.casara@chu-nimes.fr

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

Aikuinen
Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Change in quality of life Aikaikkuna: 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 Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. Aikaikkuna: 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. Aikaikkuna: 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. Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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. Aikaikkuna: 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. Aikaikkuna: 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. Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Centre Hospitalier Universitaire de Nīmes

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

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Ensimmäinen Lähetetty (Todellinen)

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Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 17. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 16. heinäkuuta 2026

Viimeksi vahvistettu

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Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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