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NCT03744377 Clinical Trial

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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03744377
Other study ID # VKVAmericanEHP30
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date December 15, 2019

Study information
Verified date November 2018
Source V.K.V. American Hospital, Istanbul
Contact Mehmet Ceyhan, MD
Phone +905426239426
Email mceyhan85@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• The Endometriosis Health Profile EPH-30
Self-reported questionnaires

Locations
Country Name City State
Turkey American Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of Endometriosis health profile-30 (EHP-30) Turkish version internal consistency and construct validity baseline
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