Domestic and/or Sexual ViolenceIROND-LNCT06226818
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
An observational study of Domestic and/or Sexual Violence, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Domestic and/or Sexual Violence
- What is being tested?
- completion of scales and questionnaires
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be identified by a doctor at one of the participating centres, on the basis of their response to the AAS questionnaire during the initial consultation.
Who may be able to join
- Women who have not objected to taking part in the trial
- Adult women (≥18 years),
- Victim of domestic and/or sexual violence, consulting at one of our study centres. Exposure to violence, whatever the initial reason for consultation, will be determined by a positive response to at least one question on the French version of the Abuse Assessment Screen, a standardised screening tool which has the advantage of not being limited to domestic violence.
- Ability to understand the objectives of the study and to answer the questionnaires
Who cannot join
- Not affiliated to the national health insurance system
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Adult who is unable to express his/her non-opposition
- Minor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Marc DOMMERGUES, 01 42 17 77 01 ext. +33, marc.dommergues@gmail.com
About this study
Official title: Assessing the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's or Traditional Health Centres: a Prospective, Quasi-experimental, Multicentre, National Study.
Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD).
In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire.
Read more
Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care.
"La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence.
Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.
- Conditions
- Domestic and/or Sexual Violence
- Being tested
- completion of scales and questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of scales and questionnairesOther
Patient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales.
Questionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Women cared for in a women's centre Receives: Other: completion of scales and questionnaires | |
| comparator group | Women in a health centre or family planning centre. Receives: Other: completion of scales and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean PCL-5 score
measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).
Measured: Through study completion, an average of 6 months
Change in the proportion of women with a PCL-5 score < 33 (validated threshold for absence of overt PTSD)
measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start8 Aug 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic and/or Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226818
- Sponsor's protocol ID
- BARDOU PREPS 2022
- Acronym
- IROND-L
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Khoury F, Ben Ghezala I, Hatem G, Jaffal Z, Soares A, Yacini L, Duchesne S, Dommergues M, Bretelle F, Eudeline S, Hoffmann P, Masse-Navette C, Layachi F, Maurice O, de Foucher de Careil T, Bardou M. IROND-L: study protocol for a French prospective, quasi-experimental, multicentre trial to examine the impact of a coordinated multidisciplinary approach for women victims of violence. BMJ Open. 2024 Nov 19;14(11):e086143. doi: 10.1136/bmjopen-2024-086143.
PubMed 39566954
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's or Traditional Health Centres: a Prospective, Quasi-experimental, Multicentre, National Study.
- ClinicalTrials.gov ID
- NCT06226818
- Acronym / sponsor ID
- IROND-L / BARDOU PREPS 2022
- Conditions
- Domestic and/or Sexual Violence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD).
In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire.
Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care.
"La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence.
Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: completion of scales and questionnairesWomen cared for in a women's centre |
| comparator group | – | Other: completion of scales and questionnairesWomen in a health centre or family planning centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified by a doctor at one of the participating centres, on the basis of their response to the AAS questionnaire during the initial consultation.
Key inclusion criteria (4 listed)
- Women who have not objected to taking part in the trial
- Adult women (≥18 years),
- Victim of domestic and/or sexual violence, consulting at one of our study centres. Exposure to violence, whatever the initial reason for consultation, will be determined by a positive response to at least one question on the French version of the Abuse Assessment Screen, a standardised screening tool which has the advantage of not being limited to domestic violence.
- Ability to understand the objectives of the study and to answer the questionnaires
Key exclusion criteria (5 listed)
- Not affiliated to the national health insurance system
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Adult who is unable to express his/her non-opposition
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of scales and questionnairesPatient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales. Questionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances. | Other | comparator group, experimental group |
Primary outcome
Change in mean PCL-5 score
Time frame: Through study completion, an average of 6 months
measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).
Change in the proportion of women with a PCL-5 score < 33 (validated threshold for absence of overt PTSD)
Time frame: Through study completion, an average of 6 months
measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 39566954El-Khoury F, Ben Ghezala I, Hatem G, Jaffal Z, Soares A, Yacini L, Duchesne S, Dommergues M, Bretelle F, Eudeline S, Hoffmann P, Masse-Navette C, Layachi F, Maurice O, de Foucher de Careil T, Bardou M. IROND-L: study protocol for a French prospective, quasi-experimental, multicentre trial to examine the impact of a coordinated multidisciplinary approach for women victims of violence. BMJ Open. 2024 Nov 19;14(11):e086143. doi: 10.1136/bmjopen-2024-086143.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Domestic and/or Sexual Violence, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc DOMMERGUES (01 42 17 77 01 ext. +33, marc.dommergues@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean PCL-5 score (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06226818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.