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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05915403
Other study ID # 2021-01-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date February 1, 2023

Study information

Verified date June 2023
Source Konya Beyhekim Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Fibromyalgia Impact Questionnaire
diagnostic tests

Locations

Country Name City State
Turkey Konya Beyhekim Research and Training Hospital Konya Selçuklu

Sponsors (1)

Lead Sponsor Collaborator
Konya Beyhekim Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 — View Citation

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. — View Citation

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/s10508-0 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale pain level 0-10, higher scores indicate worse outcome 1 week
Primary frequency of sexual intercourse mean monthly frequency of sexual intercourse in the last 3 months 3 mounths
Primary Fibromyalgia Impact Questionnaire 0-80, higher scores indicate worse outcome 1 week
Secondary Beck Depression Inventory 0-63, higher scores indicate worse outcome 1 week
Secondary Widespread Pain Index 0-19, higher scores indicate worse outcome 1 week
Secondary Symptom Severity Scale 0-12, higher scores indicate worse outcome 1 week
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