Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05272345

Collaborator

(none)

Enrollment

Locations

Arm

12.9

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Sexual Dysfunction	Procedure: sexual therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 14, 2022

Anticipated Primary Completion Date :

Feb 14, 2023

Anticipated Study Completion Date :

Mar 14, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

VAS evaluation results for pain before sexual therapy in patients with fibromyalgia [6 months]
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
VAS evaluation results for pain after sexual therapy in patients with fibromyalgia [6 months]
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
FSFI scores before sexual therapy in patients with fibromyalgia [6 months]
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.
FSFI scores after sexual therapy in patients with fibromyalgia [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 49 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,	Istanbul		Turkey
2	Pınar Kadiroğulları	Istanbul		Turkey

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Principal Investigator: Pınar Kadiroğulları, Acıbadem University Atakent Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Kadirogulları, Pinar Kadiroğulları Principal investigator , DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05272345

Other Study ID Numbers:

ATADEK/2022-03

First Posted:

Mar 9, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar Kadirogulları, Pinar Kadiroğulları Principal investigator , DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, Kanuni Sultan Suleyman Training and Research Hospital

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Study Results

No Results Posted as of Aug 19, 2022