- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07340203
Tvärkulturell anpassning, validitet och reliabilitet av Wexner-frågeformuläret hos patienter med förstoppning
Tvärkulturell anpassning, validitet och reliabilitet av Wexner-frågeformuläret
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Centre
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Kırşehir, Centre, Turkiet (Türkiye), 40000
- Kirşehir Ahi Evran University Physical Therapy and Rehabilitation Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Men and women with chronic constipation
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Application of survey to participants
Tidsram: Baseline (Day 1)
|
First administration of the Wexner questionnaire to all participants |
Baseline (Day 1)
|
|
Application of survey to participants
Tidsram: Baseline (Day 1)
|
First administration of the quality of life questionnaire to all participants |
Baseline (Day 1)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Application of survey to participants
Tidsram: Baseline (Day 1)
|
Wexner questionnaire were administered to the participants a second time two weeks later. |
Baseline (Day 1)
|
|
Application of survey to participants
Tidsram: Baseline (Day 1)
|
Quality of life questionnaire were administered to the participants a second time two weeks later. |
Baseline (Day 1)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KAEU-EBAYRAMOGLUD-003
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