EndometriosisNCT04862364
Turkish Validation Study of Endometriosis Health Profile -30 (EHP-30) Test
An observational study of Endometriosis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Endo Patients with Endometriosis Health Profile -30 (EHP-30) Test
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2021to 26 Aug 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients between the ages of 18-45 who were surgically diagnosed with endometriosis in our clinic will be included in the study. Persons with a known psychiatric illness, pregnant or using anti-depressant medication will be excluded from the study. Patients will be asked the questions of the online EHP-30 form and the answers given will be evaluated in terms of validation.
Who may be able to join
- being surgically diagnosed with endometriosis
- Age between 18- 45
- not being pregnant
Who cannot join
- have been diagnosed with endometriosis by ultrasound
- above 45 and under 18 years old
- use psichiatrig drugs
- being diagnosed with a psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.
Read the detailed description
The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic. English and Turkish translation will be verified after 2 different sworn translators.
- Conditions
- Endometriosis
- Being tested
- Endo Patients with Endometriosis Health Profile -30 (EHP-30) Test
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo Patients with Endometriosis Health Profile -30 (EHP-30) TestOther
The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
The Turkish validation study of the Endometriosis Health Profile -30EHP-30 test, which shows the general quality of life of endometriosis patients, will be performed and the use of Turkish language will be provided.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Apr 2021
- Primary completion20 Aug 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Engin Oral
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862364
- Sponsor's protocol ID
- ehp-30turkishvalidation
- Status last verified
- Aug 2021
- First submitted
- 26 Apr 2021
- Last updated
- 31 Aug 2021
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
- ClinicalTrials.gov ID
- NCT04862364
- Acronym / sponsor ID
- ehp-30turkishvalidation
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Engin Oral
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 28 Apr 2021 (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.
For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.
Detailed description
The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic. English and Turkish translation will be verified after 2 different sworn translators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients between the ages of 18-45 who were surgically diagnosed with endometriosis in our clinic will be included in the study. Persons with a known psychiatric illness, pregnant or using anti-depressant medication will be excluded from the study. Patients will be asked the questions of the online EHP-30 form and the answers given will be evaluated in terms of validation.
Key inclusion criteria (3 listed)
- being surgically diagnosed with endometriosis
- Age between 18- 45
- not being pregnant
Key exclusion criteria (4 listed)
- have been diagnosed with endometriosis by ultrasound
- above 45 and under 18 years old
- use psichiatrig drugs
- being diagnosed with a psychiatric illness
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 |
|---|---|---|
| Endo Patients with Endometriosis Health Profile -30 (EHP-30) TestThe appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic. | Other | – |
Primary outcome
Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
Time frame: 3 months
The Turkish validation study of the Endometriosis Health Profile -30EHP-30 test, which shows the general quality of life of endometriosis patients, will be performed and the use of Turkish language will be provided.
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 31 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometriosis, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 4 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 31 Aug 2021. 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?
Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test (time frame: 3 months). 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 31 Aug 2021.