Sexual Abuse of Adult (If Focus of Attention is on Victim)TESDSVNCT06721325
THERAPEUTIC EDUCATION of SEXUAL DYSFUNCTIONS in WOMEN SURVIVORS of SEXUAL VIOLENCE and FEMALE GENITAL MUTILATION
A study testing THERAPEUTIC EDUCATION IN PHYSIOTHERAPY and Psychotherapy and legal advice in people with Sexual Abuse of Adult (If Focus of Attention is on Victim) and Sexual Dysfunction Female, run by University of Alcala.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sexual Abuse of Adult (If Focus of Attention is on Victim), Sexual Dysfunction Female, Female Genital Mutilation
- What is being tested?
- THERAPEUTIC EDUCATION IN PHYSIOTHERAPY and Psychotherapy and legal advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- THERAPEUTIC EDUCATION IN PHYSIOTHERAPY, Psychotherapy and legal advice
- Keywords
- sexual violence, female genital mutilation, therapeutic education, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAPEUTIC EDUCATION IN PHYSIOTHERAPYBehavioural
Educational program of physiotherapy for women survivors of sexual violence and female genital mutilation.
Psychotherapy and legal adviceBehavioural
Usual psychological and legal advice therapy for this population
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Experimental | Psychotherapy, legal advice and physiotherapy intervention Receives: Behavioral: THERAPEUTIC EDUCATION IN PHYSIOTHERAPY; Behavioral: Psychotherapy and legal advice |
| CONTROL | Active comparator | Psychotherapy and legal advice Receives: Behavioral: Psychotherapy and legal advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Abuse of Adult (If Focus of Attention is on Victim)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721325
- Sponsor's protocol ID
- TFM_SMP2024
- Acronym
- TESDSV
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06721325
- Acronym / sponsor ID
- TESDSV / TFM_SMP2024
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Behavioral: THERAPEUTIC EDUCATION IN PHYSIOTHERAPY, Behavioral: Psychotherapy and legal advicePsychotherapy, legal advice and physiotherapy intervention |
| CONTROL | Active comparator | Behavioral: Psychotherapy and legal advicePsychotherapy and legal advice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Aged 18 and older
- No severe psychiatric disorders or inability to answer questions and questionnaires
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERAPEUTIC EDUCATION IN PHYSIOTHERAPYEducational program of physiotherapy for women survivors of sexual violence and female genital mutilation. | Behavioural | EXPERIMENTAL |
| Psychotherapy and legal adviceUsual psychological and legal advice therapy for this population | Behavioural | CONTROL, EXPERIMENTAL |
Primary outcome
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.
1 secondary outcome
Treatment Satisfaction
Time frame: After completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing THERAPEUTIC EDUCATION IN PHYSIOTHERAPY and Psychotherapy and legal advice in people with Sexual Abuse of Adult (If Focus of Attention is on Victim) and Sexual Dysfunction Female, run by University of Alcala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Muñoz-Pastor, MSc and PhD Candidate (+34662288125, silvia.munozp@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.