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Active, not recruitingNCT05272345Updated Jul 18, 2024

Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

An interventional study of sexual therapy in Fibromyalgia and Sexual Dysfunction, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Active, not recruiting at 2 sites in Turkey. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
15 Years to 49 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Fibromyalgia
  • Sexual Dysfunction

Keywords

  • Fibromyalgia
  • Patients
  • Quality of Life
  • Sexual desire
  • FSFI scala
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
  • Women Wıth A Score Greater 26.55 Wıthout Therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • Proceduresexual therapy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

07

Study locations

2 sites
  • Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
    Istanbul, Turkey
  • Pınar Kadiroğulları
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05272345
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (Pinar Kadiroğulları Principal investigator , DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Mar 9, 2022
Start date
Feb 14, 2022
Primary completion
May 14, 2024
Completion
Dec 14, 2025 (estimated)
Last update
Jul 18, 2024

Study contacts

Pınar Kadiroğulları
principal investigator · Acıbadem University Atakent Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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