NCT06038773

Brief Summary

Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to different variables that influence its clinical course.There is a growing literature which discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether there is a considerable difference in the presentation and experience of pelvic pain in women from a different societies and cultures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

20 days

First QC Date

September 7, 2023

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • McGill pain scale

    ".Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale.

    1 month

Interventions

DiagnosisDIAGNOSTIC_TEST

Baseline data were presented with descriptive statistics. Sociodemographic information, pregnancy status, surgical history, exercise habits, gynecologic, obstetric, urologic and gastrointestinal history of the patients were evaluated with the "Patient Information Form".Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale. Pain intensity during sexual intercourse was evaluated with the Visual Analog Scale (VAS).Sexual Abuse Items on the Questionnaire (Modified from Badgley).

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included 45 women with pelvic pain. Women aged 18-65 years with pelvic pain ≥6 months were eligible. The study was conducted at Yeditepe University Hospital on female patients diagnosed with chronic pelvic pain syndrome due to pelvic floor muscle problems by a gynecologist.

You may qualify if:

  • Women aged 18-65 years with pelvic pain ≥6 months were eligible.

You may not qualify if:

  • Patient who have had pelvic surgery
  • Gynecological female patients with problems other than pelvic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilüfer Cerbezer

Istanbul, 34758, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Diagnosis

Study Officials

  • nilüfer cerbezer, Msc

    Yeditepe Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 15, 2023

Study Start

June 10, 2023

Primary Completion

June 30, 2023

Study Completion

July 22, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations