Chronic Pelvic Pain SyndromeNCT06038773
Social and Clinical Aspects of Pelvic Pain in Turkey
An observational study of Chronic Pelvic Pain Syndrome, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Diagnosis
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2023to 22 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Women aged 18-65 years with pelvic pain ≥6 months were eligible.
Who cannot join
- Patient who have had pelvic surgery
- Gynecological female patients with problems other than pelvic pain
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
The study includes randomly selected 45 females who completed a comprehensive set of questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form. Character and intensity of pain, sexual abuse and harresment, coping with pain, physical activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess patients' sexual abuse status.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start10 Jun 2023
- Primary completion30 Jun 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- nilüfer cerbezer, Msc, Principal investigator, Yeditepe Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038773
- Sponsor's protocol ID
- Yeditepeu3
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Clinical Aspects of Pelvic Pain in Turkey
- ClinicalTrials.gov ID
- NCT06038773
- Acronym / sponsor ID
- Yeditepeu3
- Conditions
- Chronic Pelvic Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The study includes randomly selected 45 females who completed a comprehensive set of questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form. Character and intensity of pain, sexual abuse and harresment, coping with pain, physical activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess patients' sexual abuse status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women aged 18-65 years with pelvic pain ≥6 months were eligible.
Key exclusion criteria (2 listed)
- Patient who have had pelvic surgery
- Gynecological female patients with problems other than pelvic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosisBaseline 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). | Diagnostic test | – |
Primary outcome
McGill pain scale
Time frame: 1 month
".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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nilüfer cerbezer, Msc principal investigator
Yeditepe Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pelvic Pain Syndrome, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill pain scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.