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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744377
Recruitment Status : Unknown
Verified November 2018 by mehmet ceyhan, V.K.V. American Hospital, Istanbul.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
mehmet ceyhan, V.K.V. American Hospital, Istanbul

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Endometriosis Other: The Endometriosis Health Profile EPH-30

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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Intervention Details:
  • Other: The Endometriosis Health Profile EPH-30
    Self-reported questionnaires

Outcome Measures
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Primary Outcome Measures :
  1. Validation of Endometriosis health profile-30 (EHP-30) Turkish version [ Time Frame: baseline ]
    internal consistency and construct validity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women referred to Obstetrics and Gynecological Department for the treatment of endometriosis.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744377


Contacts
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Contact: Mehmet Ceyhan, MD +905426239426 mceyhan85@hotmail.com
Contact: Mehmet Ceyhan mceyhan85@hotmail.com

Locations
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Turkey
American Hospital
Istanbul, Turkey, 34365
Sponsors and Collaborators
V.K.V. American Hospital, Istanbul
More Information
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Responsible Party: mehmet ceyhan, Obstetrician and gynecologist, V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT03744377    
Other Study ID Numbers: VKVAmericanEHP30
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis