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临床试验/NCT06188780
NCT06188780已完成不适用

Characteristics of (Unwanted) Use of Alcohol and Illicit Substances Among Patients Reporting After Sexual Violence in Ghent: a Mono-centric Prospective Observational Study

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
toxicology results in patients with DFSA

研究概览

简要总结

This study aims at defining the patient characteristics and toxicological aspects of patients presenting at the sexual assault care centre with drugs-facilitated sexual assault.

详细描述

This study aims to map (un)voluntary use of alcohol and drugs among victims of sexual violence who present to the Care Centre after Sexual Violence at UZ Gent, referred to in English as Drug-Facilitated Sexual Assault (DFSA).

Sometimes substances are deliberately used to render a victim submissive (proactive DFSA), but it is also possible that people use substances themselves recreationally and later become victims of sexual violence (opportunistic DFSA).

Recent media reports of drinks in which psychogenic substances are involuntarily administered have become more frequent, after which people sometimes become victims of sexual violence. The public attention for this problem increased significantly recently. However, no clear data are currently available in Belgium on this problem.

Using a prospective observational study, we aim to map the incidence of (unwanted) use of alcohol and illegal substances among victims who report to the Care Centre after Sexual Violence in Ghent. The data - after obtaining informed consent - will be collected by means of (nurse-led) questionnaires and toxicological analyses on blood and urine samples. We envisage a two-year period for inclusion of patients, starting from 01/03/2023, running until 31/03/2025.

With these results, we want to estimate the proportion of sexual assault incidents in which the victim was incapacitated by voluntary or involuntary/unwanted use of alcohol or illicit substances (e.g. cannabis, GHB, cocaine, ...). To this end, we need to record data from all patients who present in order to estimate the denominator.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients (16+) who registered at the Care Center after Sexual Violence (=ZSG) in Ghent from 01/04/2023 until. 31/03/2025 and who were victims of sexual violence are eligible for inclusion in this study.

排除标准

  • Reporting longer than 5 days after the sexual assault.
  • Unable to undergo a forensic examination under the supervision of a forensic nurse due to, for example, collapse of consciousness or failure to give consent to do so.
  • Not declaring proficiency in the language in which informed consent is offered (Dutch/English)
  • Not agreeing to the informed consent.
  • Not agreeing to collection and/or analysis of blood and urine.

研究组 & 干预措施

victims of DFSA

Every patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault

干预措施: urine/blood analysis with IA and LC-GCMS analysis (Diagnostic Test)

结局指标

主要结局

toxicology results in patients with DFSA

时间窗: 19 months

Results of toxicologic analysis in patients with DFSA

patient characteristics in objectivated DFSA

时间窗: 19 months

Characteristics of patients (medical history, symptoms) after DFSA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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