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Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

Primary Purpose

Fibromyalgia, Sexual Dysfunction

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sexual therapy
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Patients, Quality of Life, Sexual desire, FSFI scala

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2022
Last Updated
March 7, 2023
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05272345
Brief Title
Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy
Official Title
Follow-Up Wıth Dıagnosıs Of Fıbromyalgıa In Patıents Wıth Sexual Functıonal Dısorder Evaluatıon Of Sexual Therapy And Post-Therapy Fıbromyalgıa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
March 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Sexual Dysfunction
Keywords
Fibromyalgia, Patients, Quality of Life, Sexual desire, FSFI scala

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibromyalgia status before sexual therapy/ Fibromyalgia condition after sex therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
sexual therapy
Intervention Description
In sexual therapy; A total of 4 sessions of therapy were initiated with the patients, one session per week for 1 month.
Primary Outcome Measure Information:
Title
VAS evaluation results for pain before sexual therapy in patients with fibromyalgia
Description
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
Title
VAS evaluation results for pain after sexual therapy in patients with fibromyalgia
Description
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
Title
FSFI scores before sexual therapy in patients with fibromyalgia
Description
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
Title
FSFI scores after sexual therapy in patients with fibromyalgia
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Kadiroğulları
Organizational Affiliation
Acıbadem University Atakent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
City
Istanbul
Country
Turkey
Facility Name
Pınar Kadiroğulları
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

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