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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Abuse of Adult (If Focus of Attention is on Victim); Sexual Dysfunction Female; Female Genital Mutilation
• Intervention / Treatment: Behavioral: THERAPEUTIC EDUCATION IN PHYSIOTHERAPY; Behavioral: Psychotherapy and legal advice

• Study Type: Interventional
• Enrollment (Estimated): 163
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Muñoz-Pastor, MSc and PhD Candidate; Phone Number: +34662288125; Email: silvia.munozp@edu.uah.es
• Study Contact Backup: Name: María Torres-Lacomba, PhD and Full professor; Phone Number: +34678900061; Email: maria.torres@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL; Psychotherapy, legal advice and physiotherapy intervention	Behavioral: THERAPEUTIC EDUCATION IN PHYSIOTHERAPY; Educational program of physiotherapy for women survivors of sexual violence and female genital mutilation.; Behavioral: Psychotherapy and legal advice; Usual psychological and legal advice therapy for this population
Active Comparator: CONTROL; Psychotherapy and legal advice	Behavioral: Psychotherapy and legal advice; Usual psychological and legal advice therapy for this population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index	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.	Before intervention (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	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.	After completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: physiotherapy; therapeutic education; sexual violence; female genital mutilation
• Other Study ID Numbers: TFM_SMP2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No