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临床试验/NCT05731297
NCT05731297招募中不适用

Perineal, Psychological and Well-beeing Consequences of Conflict-related Sexual Violence Among Women Living in Democratic Republic of Congo

Bertuit Jeanne1 个研究点 分布在 1 个国家目标入组 742 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
742
试验地点
1
主要终点
Urinary aspects

研究概览

简要总结

In conflict situations, sexual violence (SV) used can take various forms, including rape and female genital mutilation (FGM). SV is used as a strategic weapon to shake, terrorize, and displace communities and thus take control of a particular population or territory. For two decades, the Great Lakes region of Central Africa, which includes the eastern part of the Democratic Republic of the Congo (DRC), has experienced a high degree of instability due to various armed conflicts. The attacks on civilians are illustrated by SV. In 2011, studies in DRC estimated that 1 150 women are raped every day and that 30% of women have experienced conflict-related sexual violence (CRSV) over the past 16 years. In addition to physical suffering, survivors of CRSV must live with psychological consequences. Traumatic fistula, one of the most extreme consequences of SV, is well described in the literature, as its surgical management. In contrast, the literature and the government illustrate a lack of accurate data on the physical consequences such as pelvic dysfunction and psychologic disorders following these attacks. To be able to put in place adequate care, it is necessary to identify the conditions and needs of the victims.

详细描述

The project to collaborate with the DRC is initiated from an ambition of the pelvic-perineal rehabilitation unit of the Department of Physical Medicine and Rehabilitation (Faculty of Medicine, University of Kinshasa) to change the situation in relation to women and to be able to offer adequate care for this population. The project is part of collaboration with two investigators: Professor Miangindula (Université de Kinshasa, UNIKIN) in DRC and Professor Bertuit (HESAV-HES-SO) in Lausanne (Switzerland). Four partners will take part in the project enabling a competent and strong team: Professor Feipel and Professor Foucart (Université Libre de Bruxelles, ULB) in Brussels (Belgium), Doctor Abdulcadir (Hôpital Universitaire de Genève, HUG) and Professor Mukwege in Bukavu (DRC). This project pursues two objectives: firstly, to assess clinical data of pelvic floor dysfunction (pelvic floor muscle function and urinary, sexual, gynaecological, and anal function) and psychological level in women victims of CRSV compared to women not victims of CRSV in the DRC. Secondly, to investigate the current care modalities and to analyse their needs (access to care, community integration, physiotherapy, etc.) and to understand the global context of care in DRC. The project will contribute to scientific capacity building by involving two PhD students in this research. A mixed method research will include a quantitative design, an observational study in a sample of women victims of CRSV (n = 371) and a control group of women not victims of CRSV (n = 371). Outcomes on urinary, sexual, gynaecological, anorectal and psychological aspects will be collected. This study includes a qualitative study with a phenomenological approach. Individual semi-structured interviews will be conducted with women victims of CRSV (n=10). Interview topics will be complemented with quantitative data and will lead to the following themes: experiences of CRSV, consequences of CRSV on body image, and modalities and needs for caring of these consequences. Two focus groups including eight medical health professionals will complete the qualitative data collection. The project will be realized over three years in the most affected provinces of the DRC: South and North Kivu. The method for cross-referencing data will be the Sequential Explanatory Method described by Creswell (2013).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women victims of CRSV and women without a history of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study.

排除标准

  • Pregnant women and women under 18 years old.

结局指标

主要结局

Urinary aspects

时间窗: At the test time

Urinary aspects will be assessed by one questionnaire: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract SymptomsModules (ICIQ-FLUTS)

Sexual aspects

时间窗: At the test time

Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)

Pelvic and Perineal aspect

时间窗: At the test time

Pelvic and Perineal aspect will be assessed by clinical examination made by a women assistant of the research team, physiotherapist expert on pelvic floor field • Examen of observation: presence of scars, lesions, inflammation, type of FGM as described by WHO classification and types of scars during external exam; Perineal pain, intensity and localization with Haslam and Laycock ring of continence, pelvic floor muscle tone with the Reissing tone scale which have a good interrater reliability for intra-vaginal manual assessment of pubococcygeus tone for expert examinator. Laycock's power, endurance, repetitions, fast contractions, every contraction timed (PERFECT) scale will be used for pelvic floor muscle assessment. The PERFECT scheme has demonstrated good reliability and validity as an assessment tool. .

Ano-rectal aspect

时间窗: At the test time

Two questionnaires will be used; one to assess anal incontinence (AI) and one for constipation * The St. Mark's Incontinence Score (SMIS) * The Knowles, Eccersley, Scott Symptom Score (KESS

次要结局

  • Psychological aspect: will assessing with be PCL-5 questionnaire(At the test time)
  • Quality of Life (QoL)(At the test time)

研究者

发起方
Bertuit Jeanne
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bertuit Jeanne

Principal Investigator

University of Applied Sciences of Western Switzerland

研究点 (1)

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