Frequency of Sexual Intercourse,Women With Fibromyalgia

June 21, 2023 updated by: Savaş Karpuz, Konya Beyhekim Training and Research Hospital

The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia

Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Selçuklu
      • Konya, Selçuklu, Turkey, 42060
        • Konya Beyhekim Research and training hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

tertiary healthcare facility

Description

Inclusion Criteria:

* Female patient with fibromyalgia

Exclusion Criteria:

  • Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),
  • Major psychiatric disease,
  • Endocrine disease,
  • Pregnancy
  • Menopausal status,
  • Antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
female patient with fibromyalgia
Diagnostic test: Fibromyalgia Impact Questionnaire
diagnostic tests
Other Names:
  • Beck Depression Inventory
  • Visual Analog Scale
  • Widespread Pain Index
  • Symptom Severity Scale
  • frequency of sexual intercourse
healthy controls
women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 1 week
pain level 0-10, higher scores indicate worse outcome
1 week
frequency of sexual intercourse
Time Frame: 3 mounths
mean monthly frequency of sexual intercourse in the last 3 months
3 mounths
Fibromyalgia Impact Questionnaire
Time Frame: 1 week
0-80, higher scores indicate worse outcome
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: 1 week
0-63, higher scores indicate worse outcome
1 week
Widespread Pain Index
Time Frame: 1 week
0-19, higher scores indicate worse outcome
1 week
Symptom Severity Scale
Time Frame: 1 week
0-12, higher scores indicate worse outcome
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Beyhekim Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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