Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

Fibromyalgia Clinical Trial

Official title:

Follow-Up Wıth Dıagnosıs Of Fıbromyalgıa In Patıents Wıth Sexual Functıonal Dısorder Evaluatıon Of Sexual Therapy And Post-Therapy Fıbromyalgıa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05272345
• Other study ID #: ATADEK/2022-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: March 2023
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 consulted with obstetricians.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Follow-up with a diagnosis of fibromyalgia
• Reproductive age (15-49 years)
• Women with sexual dysfunction (FSFI score < 26.55)

Exclusion Criteria:

• Women With Ibromyalgia Without Sexual Dysfunction
• Women With A Score Greater 26.55 Without Therapy

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Sexual Dysfunction

Intervention

Procedure:
• sexual therapy
In sexual therapy; A total of 4 sessions of therapy were initiated with the patients, one session per week for 1 month.

Locations

Country	Name	City	State
Turkey	Acibadem University Atakent Hospital, Department of Obstetrics and Gynecology,	Istanbul
Turkey	Pinar Kadirogullari	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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.	6 months
Primary	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.	6 months