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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06415968
Other study ID # NIMAO/2023-2/JCG-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Nimes
Contact Jean-Christophe Gris
Phone 04.66.68.32.11
Email jean.christophe.gris@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world. The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French. Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases). The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3240
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship - Willing to complete the anonymous WAST self-questionnaire - able to read and understand French - Outpatient consultant at Nîmes University Hospital in one of the following departments: - Biological hematology consultation - Clinical hematology consultation - Vascular medicine consultation Exclusion Criteria: - Individuals under court protection, guardianship or curatorship - Individuals unable to read and understand French - Individuals who have already completed the WAST questionnaire during the study period - Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHUNimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of patients experiencing Intimate Partner Violence according to consulting department Percentage of patients with a Women Abuse Screening Tool (WAST) score = 5 consulting in the hemostasis pathology versus cellular hematological pathology department. The WAST is an 8-item questionnaire with a score ranging from 0 to 16 (worst violence), with a cut-off of 5 for presence of violence Day 0
Secondary Prevalence of Intimate Partner Violence in men versus women according to consulting department WAST score = 5 consulting in the hemostasis pathology versus cellular hematological pathology department in women versus men Day 0
Secondary Prevalence of Intimate Partner Violence according to patient disease status and gender WAST questionnaire total score in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology Day 0
Secondary WAST questionnaire score according to patient disease status and gender Score for individual items of WAST questionnaire in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology Day 0
Secondary Association between the major risk factors for Intimate Partner Violence and WAST score. WAST questionnaire total score according to: Number of years together, Violence at home growing up, Marital status (divorced or separated), Children living at home, Working status, Finances (personal income, financial difficulties), Living status (together vs separate, size of dwelling, neighbors nearby), Health status of living partner, Health status of patient Day 0
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