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

NCT06721325 | Not Yet Recruiting

• 1 other identifier: TFM_SMP2024
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexual Abuse of Adult (If Focus of Attention is on Victim); Sexual Dysfunction Female; Female Genital Mutilation

Keywords

sexual violence; female genital mutilation; therapeutic education; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment Satisfaction

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

Study Arms (2)

EXPERIMENTAL

EXPERIMENTAL

Psychotherapy, legal advice and physiotherapy intervention

Behavioral: THERAPEUTIC EDUCATION IN PHYSIOTHERAPY; Behavioral: Psychotherapy and legal advice

CONTROL

ACTIVE COMPARATOR

Psychotherapy and legal advice

Behavioral: Psychotherapy and legal advice

Interventions

THERAPEUTIC EDUCATION IN PHYSIOTHERAPY BEHAVIORAL

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

EXPERIMENTAL

Psychotherapy and legal advice BEHAVIORAL

Usual psychological and legal advice therapy for this population

CONTROL; EXPERIMENTAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

MeSH Terms

Interventions

Physical Therapy Modalities; Psychotherapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Behavioral Disciplines and Activities

Central Study Contacts

Silvia Muñoz-Pastor, MSc and PhD Candidate

CONTACT

+34662288125; silvia.munozp@edu.uah.es

María Torres-Lacomba, PhD and Full professor

CONTACT

+34678900061; maria.torres@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: December 6, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share