- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915403
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
-
-
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 tests
Other Names:
|
|
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.
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
- Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
- Maunder L, Schoemaker D, Pruessner JC. Frequency of Penile-Vaginal Intercourse is Associated with Verbal Recognition Performance in Adult Women. Arch Sex Behav. 2017 Feb;46(2):441-453. doi: 10.1007/s10508-016-0890-4. Epub 2016 Nov 14.
- Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Invest. 1999;47(2):125-6. doi: 10.1159/000010075.
- Burleson MH, Trevathan WR, Todd M. In the mood for love or vice versa? Exploring the relations among sexual activity, physical affection, affect, and stress in the daily lives of mid-aged women. Arch Sex Behav. 2007 Jun;36(3):357-68. doi: 10.1007/s10508-006-9071-1.
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.