NCT05272345

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Completed
1 day until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2.2 years

First QC Date

February 13, 2022

Last Update Submit

July 17, 2024

Conditions

Keywords

FibromyalgiaPatientsQuality of LifeSexual desireFSFI scala

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

Procedure: sexual therapy

Interventions

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

Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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)

Location

Pınar Kadiroğulları

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Pınar Kadiroğulları

    Acıbadem University Atakent Hospital

    PRINCIPAL INVESTIGATOR

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

Locations