Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:07 AM
Study NCT ID:
NCT07340203
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-Cultural Adaptation, Validity, and Reliability of the Wexner Questionnaire in Patients With Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Application of survey to participants', 'timeFrame': 'approximately 1 month', 'description': 'First administration of the Wexner questionnaire to all participants'}, {'measure': 'Application of survey to participants', 'timeFrame': 'approximately 1 month', 'description': 'First administration of the quality of life questionnaire to all participants'}], 'secondaryOutcomes': [{'measure': 'Application of survey to participants', 'timeFrame': 'approximately 1 week', 'description': 'Wexner questionnaire were administered to the participants a second time two weeks later.'}, {'measure': 'Application of survey to participants', 'timeFrame': 'approximately 1 week', 'description': 'Quality of life questionnaire were administered to the participants a second time two weeks later.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation - Functional']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women with chronic constipation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being over 18 years of age\n2. Being diagnosed with functional constipation according to Rome IV criteria\n3. Having undergone an anorectal examination by a gastroenterologist\n4. Having no history of neurodegenerative disease (e.g., multiple sclerosis, spinal cord injury, or stroke)\n5. Having no history of metabolic disorders (e.g., diabetes, hypothyroidism, or hypercalcemia)\n6. Having no history of opioid-induced constipation\n7. Having no history of irritable bowel syndrome\n8. Having no history of congenital anorectal abnormality\n9. Having no history of colon cancer or pregnancy\n10. Having the ability to read and write Turkish.\n\nExclusion Criteria:\n\n1. Not wanting to continue the study.\n2. Having any complaints, such as anorectal bleeding, during the test-retest interval.'}, 'identificationModule': {'nctId': 'NCT07340203', 'briefTitle': 'Cross-Cultural Adaptation, Validity, and Reliability of the Wexner Questionnaire in Patients With Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evran University Education and Research Hospital'}, 'officialTitle': 'Cross-Cultural Adaptation, Validity, and Reliability of the Wexner Questionnaire', 'orgStudyIdInfo': {'id': 'KAEU-EBAYRAMOGLUD-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER', 'otherNames': ['questionnaire'], 'description': 'survey application'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40000', 'city': 'Kırşehir', 'state': 'Centre', 'country': 'Turkey (Türkiye)', 'facility': 'Kirşehir Ahi Evran University Physical Therapy and Rehabilitation Hospital', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evran University Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Doctor', 'investigatorFullName': 'Esra BAYRAMOĞLU DEMİRDÖĞEN', 'investigatorAffiliation': 'Ahi Evran University Education and Research Hospital'}}}}