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Frequency of Sexual Intercourse,Women With Fibromyalgia

Sponsor
Konya Beyhekim Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05915403
Collaborator
(none)
200
Enrollment
1
Location
14
Actual Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fibromyalgia Impact Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patient

female patient with fibromyalgia

Diagnostic Test: Fibromyalgia Impact Questionnaire
diagnostic tests
Other Names:
  • Visual Analog Scale
  • Beck Depression Inventory
  • Widespread Pain Index
  • Symptom Severity Scale
  • frequency of sexual intercourse

    		•
    healthy controls

    women

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale [1 week]

      pain level 0-10, higher scores indicate worse outcome

    2. frequency of sexual intercourse [3 mounths]

      mean monthly frequency of sexual intercourse in the last 3 months

    3. Fibromyalgia Impact Questionnaire [1 week]

      0-80, higher scores indicate worse outcome

    Secondary Outcome Measures

    1. Beck Depression Inventory [1 week]

      0-63, higher scores indicate worse outcome

    2. Widespread Pain Index [1 week]

      0-19, higher scores indicate worse outcome

    3. Symptom Severity Scale [1 week]

      0-12, higher scores indicate worse outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konya Beyhekim Research and Training Hospital Konya Selçuklu Turkey 42060

    Sponsors and Collaborators

    • Konya Beyhekim Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Savaş Karpuz, Medical doctor, Konya Beyhekim Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05915403
    Other Study ID Numbers:
    • 2021-01-05
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes

    Study Results

    No Results Posted as of Jun 23, 2023