Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis

November 14, 2018 updated by: mehmet ceyhan, V.K.V. American Hospital, Istanbul
Endometriosis can affect quality of life, including physical, psychological and social aspects. It is important to include quality of life measures in evaluating disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30) from in-depth interviews with patients with endometriosis is currently the most reliable questionnaire for the measurement of health-related quality of life in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis. The aim of the present study is to validate the Turkish version of EPH 30, a self reported questionnaiere already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34365
        • American Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women referred to Obstetrics and Gynecological Department for the treatment of endometriosis.

Description

Inclusion Criteria:

  • Previous surgical and histological diagnosis of endometriosis

Exclusion Criteria:

  • Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
  • Psychiatric diseases
  • Refusal or inability to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of Endometriosis health profile-30 (EHP-30) Turkish version
Time Frame: baseline
internal consistency and construct validity
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

V.K.V. American Hospital, Istanbul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2018

Primary Completion (Anticipated)

July 15, 2019

Study Completion (Anticipated)

December 15, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VKVAmericanEHP30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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