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临床试验/NCT06721325
NCT06721325尚未招募不适用

EFFECTIVENESS of THERAPEUTIC EDUCATION in the PREVENTION and MANAGEMENT of SEXUAL DYSFUNCTIONS in WOMEN SURVIVORS of SEXUAL VIOLENCE and FEMALE GENITAL MUTILATION: RANDOMIZED CLINICAL TRIAL

University of Alcala0 个研究点目标入组 163 人开始时间: 2024年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
163
主要终点
Female Sexual Function Index

研究概览

简要总结

Violence against women is a problem that affects women all over the planet, causing physical, emotional, and other repercussions for its survivors. Pelvic floor dysfunctions, especially female sexual dysfunctions, are among the most common physical consequences for women who have suffered sexual violence or female genital mutilation. Pelvic floor physiotherapy is the first-line treatment for these dysfunctions, with therapeutic education being one of its main strategies due to its importance in the cognitive approach and for promoting patient adherence to the proposed treatments. Women who are survivors of sexual violence and female genital mutilation, being at risk for these disorders, express the need to receive information about these dysfunctions and their possible treatments. However, it has been shown that their knowledge in this regard is limited. Therefore, a project is proposed with the objective of determining the effectiveness of an intervention based on therapeutic education in the prevention and management of sexual dysfunctions secondary to sexual violence or female genital mutilation. A group educational program is proposed, which allows survivor women to address these dysfunctions in a non-invasive way. Six sessions are planned to promote the development of various competencies: communicating their needs, integrating knowledge about their health problem, identifying and analyzing, decision-making and know-how, problem-solving, using healthcare resources and asserting their rights. This will provide these women a safe space to share their experiences, learn to manage them, acquire knowledge about the pelvic floor, related dysfunctions and their treatment, as well as self-efficacy tools for dealing with sexual dysfunctions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who have suffered sexual assault:
  • Aged 18 and older
  • No severe psychiatric disorders or any other condition that prevents them from answering questions and questionnaires
  • Emotionally prepared to address the affected physical and sexual sphere
  • Women who have undergone Female Genital Mutilation:
  • Aged 18 and older
  • No severe psychiatric disorders or inability to answer questions and questionnaires
  • Emotionally prepared to address the affected physical and sexual sphere

排除标准

  • Women who have suffered sexual assaults in the context of trafficking of women and girls for sexual exploitation.
  • Women who have difficulty understanding the Spanish language.
  • Women who are not psychologically prepared to address their sexuality.

结局指标

主要结局

Female Sexual Function Index

时间窗: Before intervention (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

Assessed using the Spanish version of the FSFI. The FSFI is a 19-item questionnaire that evaluates sexual function across six domains: desire, arousal, lubrication, orgasm, satis-faction, and pain. Each domain is scored from 0 to 5, with higher scores indicating better sexual function. The total FSFI score ranges from 2 to 36, with higher scores reflecting improved sexual function.

次要结局

  • Treatment Satisfaction(After completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Torres Lacomba

Full professor

University of Alcala

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