CClinicalTrials.gg
CompletedNCT07344675Updated Feb 27, 2026

Fibromyalgia Syndrome and Chronic Pelvic Pain

An observational study in Fibromyalgia, Fibromyalgia Syndrome and Pain, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
128
Ages
18 Years and older
Sex
Female
01

Study summary

This study aimed to compare patients with and without fibromyalgia syndrome in terms of chronic pelvic pain and pelvic floor dysfunction.

Read the detailed description

The study planned for two patient groups in the Physical Medicine and Rehabilitation outpatient clinic: female patients followed up for fibromyalgia and a control group matched for age and gender without fibromyalgia syndrome. Demographic data, symptom duration, chronic pelvic pain, and pelvic dysfunction symptoms will be assessed in both groups. Pain levels will be measured using the Visual Analog Scale and the McGill Pain Questionnaire Short Form. Additionally, the Fibromyalgia Impact Questionnaire, the Chronic Pelvic Pain Impact Questionnaire, and the Short Form-12 for quality of life assessment will be completed.

02

Conditions studied

  • Fibromyalgia
  • Fibromyalgia Syndrome
  • Pain
  • Chronic Pelvic Pain
  • Chronic Pelvic Pain Syndrome (CPPS)

Keywords

  • fibromyalgia
  • chronic pelvic pain
  • pain
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 128 is above the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Female participants aged 18 and over, with and without fibromyalgia syndrome

Inclusion criteria

  • Female participants aged 18 and over
  • Voluntary participation in the study

Exclusion criteria

Exclusion Criteria:

  • Individuals with cognitive impairment
  • History of pelvic surgery within the last 3 months
  • Severe cardiac, renal, liver disease, respiratory or endocrine dysfunction, uncontrolled psychiatric illness
  • Pregnant or breastfeeding women
  • Individuals with neuropathy or central nervous system disorders
  • History of neoplasm in the pelvic region
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
128 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Those with fibromyalgia syndrome

    Female patients with a history of follow-up and treatment due to fibromyalgia syndrome

  • Female patients presenting to the outpatient clinic who do not have fibromyalgia syndrome

    Patients who do not have a history of fibromyalgia syndrome and who present to the outpatient clinic for other reasons

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    The score is obtained by measuring, with a ruler, the distance in millimeters along the 10-cm line from the "no pain" reference point to the mark indicated by the patient, yielding a total score between 0 and 100, where higher values reflect increased pain severity.

    Time frame: Day 1

  2. Short-Form McGill Pain Questionnaire

    The Short-Form McGill Pain Questionnaire was developed as a condensed version of the original instrument. Its core section includes 15 pain descriptors, consisting of 11 sensory and 4 affective items, each rated according to intensity on a 4-point scale from 0 (no pain) to 3 (severe pain).

    Time frame: Day 1

  3. Pelvic Pain Impact Questionnaire

    The self-administered Pelvic Pain Impact Questionnaire assesses the effect of pelvic pain on daily life. It comprises 8 mandatory and 2 optional items, each rated on a 5-point Likert scale, yielding a total score from 0 to 32, with higher scores indicating greater impact on daily functioning.

    Time frame: Day 1

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire

    The Fibromyalgia Impact Questionnaire (FIQ) is a self-administered tool consisting of 10 items; the first item includes 11 questions assessing physical functioning, each rated on a 4-point Likert-type scale.

    Time frame: Day 1

07

Study locations

1 site
  • Şişli Hamidiye Etfal Training and Research Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07344675
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Selda Çiftci (Medical doctor, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Jan 15, 2026
Start date
Jul 1, 2025
Primary completion
Jan 15, 2026
Completion
Feb 1, 2026
Last update
Feb 27, 2026

Study contacts

Banu Kuran, Professor
study director · Şişli Hamidiye Etfal Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion