FibromyalgiaNCT05272345
Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy
A study testing sexual therapy in people with Fibromyalgia and Sexual Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
investigators aim to re-evaluate the findings of Fibromyalgia in patients whose FSFI scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the FSFI scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Sexual Dysfunction
- What is being tested?
- sexual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 14 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Follow-up with a diagnosis of fibromyalgia
- Reproductive age (15-49 years)
- Women with sexual dysfunction (FSFI score < 26.55)
Who cannot join
- Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
- Women Wıth A Score Greater 26.55 Wıthout Therapy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Istanbul
Pınar Kadiroğulları
Istanbul
About this study
Official title: Follow-Up Wıth Dıagnosıs Of Fıbromyalgıa In Patıents Wıth Sexual Functıonal Dısorder Evaluatıon Of Sexual Therapy And Post-Therapy Fıbromyalgıa
investigators aim to re-evaluate the findings of Fibromyalgia in patients whose FSFI scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the FSFI scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators consulted with obstetricians.
Read the detailed description
Apart from routine Fibromyalgia treatments, investigators think that Fibromyalgia patients should be evaluated in detail in terms of sexual dysfunction, and better results will be obtained by adding sexual therapy to the treatment in patients with FSFI score below 26.55.
In the current literature review, investigators have seen that there is no study on the evaluation of fibromyalgia before and after sexual therapy.
investigators think that our study will be a pioneer in terms of showing the importance of the multidisciplinary approach in the treatment of Fibromyalgia.
investigators foresee that sexuality is still a subject that is avoided to be talked about due to the cultural infrastructure of developing countries, and that Fibromyalgia will actually decrease with the regulation of sexual life.
investigators believe that more comprehensive studies with this perspective will develop a multidisciplinary approach in Fibromyalgia.
- Conditions
- Fibromyalgia, Sexual Dysfunction
- Being tested
- sexual therapy
- Keywords
- Fibromyalgia, Patients, Quality of Life, Sexual desire, FSFI scala
- Medical subject headings
- Fibromyalgia, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual therapyProcedure or surgery
In sexual therapy; A total of 4 sessions of therapy were initiated with the patients, one session per week for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy | Experimental | * Women with sexual dysfunction (FSFI score < 26.55) in reproductive age (15-49 years) followed up with a diagnosis of fibromyalgia
* Women with sexual dysfunction (FSFI score < 26.55) in reproductive age (15-49 years) followed up with a diagnosis of fibromyalgia and who were reevaluated for fibromyalgia after sexual therapy was given Receives: Procedure: sexual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS evaluation results for pain before sexual therapy in patients with fibromyalgia
Evaluation results of women with fibromyalgia diagnosis with VAS SCAL VAS SCALE; THE PATIENT IS REQUESTED TO VALUE THE PAIN BETWEEN 0-10. 0 ; NO PAIN 10: SEVERE PAIN
Measured: 6 months
VAS evaluation results for pain after sexual therapy in patients with fibromyalgia
Evaluation results of women with fibromyalgia diagnosis with VAS SCAL after sexual therapy VAS SCALE; THE PATIENT IS REQUESTED TO VALUE THE PAIN BETWEEN 0-10. 0 ; NO PAIN 10: SEVERE PAIN
Measured: 6 months
FSFI scores before sexual therapy in patients with fibromyalgia
Evaluation results of women with fibromyalgia diagnosis with FSFI SCAL
- The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 after the product of the coefficients, and the lowest score is 2. Effect coefficients used for scoring the whole scale; 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. A FSFI score below 26.55 was defined as compatible with sexual dysfunction.
Measured: 6 months
FSFI scores after sexual therapy in patients with fibromyalgia
Evaluation results of women with fibromyalgia diagnosis with FSFI SCAL after sexual therapy
- The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 after the product of the coefficients, and the lowest score is 2. Effect coefficients used for scoring the whole scale; 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. A FSFI score below 26.55 was defined as compatible with sexual dysfunction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start14 Feb 2022
- Primary completion14 May 2024
- Study completion14 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Pınar Kadiroğulları, Principal investigator, Acıbadem University Atakent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272345
- Sponsor's protocol ID
- ATADEK/2022-03
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Wıth Dıagnosıs Of Fıbromyalgıa In Patıents Wıth Sexual Functıonal Dısorder Evaluatıon Of Sexual Therapy And Post-Therapy Fıbromyalgıa
- ClinicalTrials.gov ID
- NCT05272345
- Acronym / sponsor ID
- ATADEK/2022-03
- Conditions
- Fibromyalgia, Sexual Dysfunction
- Keywords
- Fibromyalgia, Patients, Quality of Life, Sexual desire, FSFI scala
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 Dec 2025 (estimated)
- First posted
- 9 Mar 2022 (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.
investigators aim to re-evaluate the findings of Fibromyalgia in patients whose FSFI scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the FSFI scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators consulted with obstetricians.
Detailed description
Apart from routine Fibromyalgia treatments, investigators think that Fibromyalgia patients should be evaluated in detail in terms of sexual dysfunction, and better results will be obtained by adding sexual therapy to the treatment in patients with FSFI score below 26.55.
In the current literature review, investigators have seen that there is no study on the evaluation of fibromyalgia before and after sexual therapy.
investigators think that our study will be a pioneer in terms of showing the importance of the multidisciplinary approach in the treatment of Fibromyalgia.
investigators foresee that sexuality is still a subject that is avoided to be talked about due to the cultural infrastructure of developing countries, and that Fibromyalgia will actually decrease with the regulation of sexual life.
investigators believe that more comprehensive studies with this perspective will develop a multidisciplinary approach in Fibromyalgia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy | Experimental | Procedure: sexual therapy* Women with sexual dysfunction (FSFI score < 26.55) in reproductive age (15-49 years) followed up with a diagnosis of fibromyalgia * Women with sexual dysfunction (FSFI score < 26.55) in reproductive age (15-49 years) followed up with a diagnosis of fibromyalgia and who were reevaluated for fibromyalgia after sexual therapy was given |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Follow-up with a diagnosis of fibromyalgia
- Reproductive age (15-49 years)
- Women with sexual dysfunction (FSFI score < 26.55)
Key exclusion criteria (2 listed)
- Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
- Women Wıth A Score Greater 26.55 Wıthout Therapy
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 |
|---|---|---|
| sexual therapyIn sexual therapy; A total of 4 sessions of therapy were initiated with the patients, one session per week for 1 month. | Procedure or surgery | Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy |
Primary outcome
VAS evaluation results for pain before sexual therapy in patients with fibromyalgia
Time frame: 6 months
Evaluation results of women with fibromyalgia diagnosis with VAS SCAL VAS SCALE; THE PATIENT IS REQUESTED TO VALUE THE PAIN BETWEEN 0-10. 0 ; NO PAIN 10: SEVERE PAIN
VAS evaluation results for pain after sexual therapy in patients with fibromyalgia
Time frame: 6 months
Evaluation results of women with fibromyalgia diagnosis with VAS SCAL after sexual therapy VAS SCALE; THE PATIENT IS REQUESTED TO VALUE THE PAIN BETWEEN 0-10. 0 ; NO PAIN 10: SEVERE PAIN
FSFI scores before sexual therapy in patients with fibromyalgia
Time frame: 6 months
Evaluation results of women with fibromyalgia diagnosis with FSFI SCAL * The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 after the product of the coefficients, and the lowest score is 2. Effect coefficients used for scoring the whole scale; 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. A FSFI score below 26.55 was defined as compatible with sexual dysfunction.
FSFI scores after sexual therapy in patients with fibromyalgia
Time frame: 6 months
Evaluation results of women with fibromyalgia diagnosis with FSFI SCAL after sexual therapy * The FSFI questionnaire consists of 19 questions; It evaluates 6 main factors as sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and the highest score is 36 after the product of the coefficients, and the lowest score is 2. Effect coefficients used for scoring the whole scale; 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. A FSFI score below 26.55 was defined as compatible with sexual dysfunction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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. This study is not recruiting at the moment.
Pınar Kadiroğulları principal investigator
Acıbadem University Atakent Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual therapy in people with Fibromyalgia and Sexual Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS evaluation results for pain before sexual therapy in patients with fibromyalgia (time frame: 6 months). The study lists 4 primary outcomes in all. 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 18 Jul 2024.