Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fibromyalgia; Sexual Dysfunction
• Intervention / Treatment: Procedure: sexual therapy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
  • Istanbul, Turkey
    • Pınar Kadiroğulları

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Wıth Ibromyalgıa Wıthout Sexual Dysfunction
• Women Wıth A Score Greater 26.55 Wıthout Therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Pınar Kadiroğulları, Acıbadem University Atakent Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): May 14, 2024
• Study Completion (Estimated): December 14, 2025

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Patients; Fibromyalgia; Sexual desire; FSFI scala
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: ATADEK/2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No