- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340203
Cross-Cultural Adaptation, Validity, and Reliability of the Wexner Questionnaire in Patients With Constipation
Cross-Cultural Adaptation, Validity, and Reliability of the Wexner Questionnaire
The investigators will conduct a validity and reliability study of the Wexner Constipation Questionnaire, used for constipation, in Turkish. For this purpose, investigators will administer the Wexner Questionnaire, translated from English to Turkish, and the accompanying Constipation Quality of Life Scale to 200 participants. Investigators will repeat the Wexner questionnaire for some participants after two weeks.
Study Overview
Detailed Description
To assess the cultural adaptation, validity, and reliability of the eight-question Wexner Constipation Questionnaire, the questionnaire was first translated from English to Turkish, then back from Turkish to English, and finally back from English to Turkish. The questionnaire was finalized with the collaboration of an internal medicine specialist and a gastroenterologist to prepare the Turkish version. It will then be administered to a minimum of 200 participants, along with the Constipation Quality of Life Questionnaire, previously validated and reliable in Turkish and used for constipation. For reliability, the questionnaire will be repeated for a portion of the participants after two weeks.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Centre
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Kırşehir, Centre, Turkey (Türkiye), 40000
- Kirşehir Ahi Evran University Physical Therapy and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Men and women with chronic constipation
Description
Inclusion Criteria:
- Being over 18 years of age
- Being diagnosed with functional constipation according to Rome IV criteria
- Having undergone an anorectal examination by a gastroenterologist
- Having no history of neurodegenerative disease (e.g., multiple sclerosis, spinal cord injury, or stroke)
- Having no history of metabolic disorders (e.g., diabetes, hypothyroidism, or hypercalcemia)
- Having no history of opioid-induced constipation
- Having no history of irritable bowel syndrome
- Having no history of congenital anorectal abnormality
- Having no history of colon cancer or pregnancy
- Having the ability to read and write Turkish.
Exclusion Criteria:
- Not wanting to continue the study.
- Having any complaints, such as anorectal bleeding, during the test-retest interval.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Application of survey to participants
Time Frame: Baseline (Day 1)
|
First administration of the Wexner questionnaire to all participants |
Baseline (Day 1)
|
|
Application of survey to participants
Time Frame: Baseline (Day 1)
|
First administration of the quality of life questionnaire to all participants |
Baseline (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Application of survey to participants
Time Frame: Baseline (Day 1)
|
Wexner questionnaire were administered to the participants a second time two weeks later. |
Baseline (Day 1)
|
|
Application of survey to participants
Time Frame: Baseline (Day 1)
|
Quality of life questionnaire were administered to the participants a second time two weeks later. |
Baseline (Day 1)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEU-EBAYRAMOGLUD-003
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