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

• Sponsor: V.K.V. American Hospital, Istanbul (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03744377
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 23.1

Study Details

Study Description

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	Phase
Endometriosis	Other: The Endometriosis Health Profile EPH-30

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation ( Endometriosis Health Profile) EHP-30 (Turkish Version) for Patients With Endometriosis
• Anticipated Study Start Date: Nov 15, 2018
• Anticipated Primary Completion Date: Jul 15, 2019
• Anticipated Study Completion Date: Dec 15, 2019

Outcome Measures

Primary Outcome Measures

1. Validation of Endometriosis health profile-30 (EHP-30) Turkish version [baseline]

   internal consistency and construct validity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	American Hospital	Istanbul		Turkey	34365

Sponsors and Collaborators

• V.K.V. American Hospital, Istanbul

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mehmet ceyhan, Obstetrician and gynecologist, V.K.V. American Hospital, Istanbul
• ClinicalTrials.gov Identifier: NCT03744377
• Other Study ID Numbers: VKVAmericanEHP30
• First Posted: Nov 16, 2018
• Last Update Posted: Nov 16, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Nov 16, 2018