NCT05915403

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 12, 2023

Last Update Submit

June 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    pain level 0-10, higher scores indicate worse outcome

    1 week

  • frequency of sexual intercourse

    mean monthly frequency of sexual intercourse in the last 3 months

    3 mounths

  • Fibromyalgia Impact Questionnaire

    0-80, higher scores indicate worse outcome

    1 week

Secondary Outcomes (3)

  • Beck Depression Inventory

    1 week

  • Widespread Pain Index

    1 week

  • Symptom Severity Scale

    1 week

Study Arms (2)

Patient

female patient with fibromyalgia

Diagnostic Test: Fibromyalgia Impact Questionnaire

healthy controls

women

Interventions

diagnostic tests

Also known as: Visual Analog Scale, Beck Depression Inventory, Widespread Pain Index, Symptom Severity Scale, frequency of sexual intercourse
Patient

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

tertiary healthcare facility

You may qualify if:

  • \* Female patient with fibromyalgia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Research and Training Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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.

MeSH Terms

Conditions

FibromyalgiaPainDepression

Interventions

Visual Analog Scale

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 23, 2023

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations