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
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2022
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2025
CompletedJuly 18, 2024
July 1, 2024
2.2 years
February 13, 2022
July 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
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
Interventions
In sexual therapy; A total of 4 sessions of therapy were initiated with the patients, one session per week for 1 month.
Eligibility Criteria
You may qualify if:
- Follow-up with a diagnosis of fibromyalgia
- Reproductive age (15-49 years)
- Women with sexual dysfunction (FSFI score \< 26.55)
You may not qualify if:
- Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
- Women Wıth A Score Greater 26.55 Wıthout Therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Istanbul, Turkey (Türkiye)
Pınar Kadiroğulları
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pınar Kadiroğulları
Acıbadem University Atakent Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pinar Kadiroğulları Principal investigator , DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
Study Record Dates
First Submitted
February 13, 2022
First Posted
March 9, 2022
Study Start
February 14, 2022
Primary Completion
May 14, 2024
Study Completion
December 14, 2025
Last Updated
July 18, 2024
Record last verified: 2024-07