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NCT Number: NCT06721325

THERAPEUTIC EDUCATION of SEXUAL DYSFUNCTIONS in WOMEN SURVIVORS of SEXUAL VIOLENCE and FEMALE GENITAL MUTILATION

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

THERAPEUTIC EDUCATION IN PHYSIOTHERAPY

Behavioral

Educational program of physiotherapy for women survivors of sexual violence and female genital mutilation.

Psychotherapy and legal advice

Behavioral

Usual psychological and legal advice therapy for this population

Primary outcomes

  1. Female Sexual Function Index

    Time frame: 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.

Secondary outcomes

  1. Treatment Satisfaction

    Time frame: After completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1

    Satisfaction with the treatment will be assessed using a numerical verbal scale ranging from 0 to 10, where 0 represents no satisfaction and 10 indicates ex-cellent satisfaction. This evaluation will begin with assessment A1.

Study contacts

Contact information is provided by the study sponsor or research team.

María Torres-Lacomba, PhD and Full professor

CONTACT

[email protected]

+34678900061

Silvia Muñoz-Pastor, MSc and PhD Candidate

CONTACT

[email protected]

+34662288125

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Acronym: TESDSV

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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