- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07838259
Final Examination Stress and Bowel Symptoms
The Effect of Final Examination Stress on Bowel Symptoms in University Students
This prospective observational study aims to investigate the association between final examination stress and bowel symptoms in university students. Participants will be evaluated during the final examination period, which represents a naturally occurring period of increased academic stress. Bowel-related symptoms, including constipation-related complaints, defecation-related pain, stool characteristics, and urgency, will be assessed. Participants will also complete a 7-day diary to record bowel characteristics and selected lifestyle factors, including sleep duration, daily step count, and fluid intake. These factors will be examined as potential variables associated with bowel symptoms during the examination period.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
University students may experience increased psychological stress during final examination periods due to academic workload, performance expectations, and time pressure. Stress may influence gastrointestinal function through alterations in the brain-gut axis, autonomic nervous system activity, gastrointestinal motility, and visceral sensitivity. Examination periods may also be accompanied by changes in daily lifestyle behaviors, such as sleep duration, physical activity, and fluid intake, which may further influence bowel function.
This prospective, observational, analytical study is designed to evaluate bowel symptoms among university students during the final examination period. Participants will complete a sociodemographic and clinical information form and will be assessed for constipation-related symptoms using Rome IV-based questions. Additional bowel-related characteristics, including pain during defecation, pain intensity and location, urgency to defecate, and stool type, will be recorded.
Participants will also complete a 7-day follow-up diary during the final examination period. The diary will include daily records of defecation-related symptoms and stool characteristics as well as daily fluid intake, step count, and sleep duration. Daily step count and sleep duration will be considered potential lifestyle-related factors associated with bowel symptoms rather than primary outcomes.
The primary objective of the study is to investigate bowel symptoms during a period of final examination stress in university students. Secondary objectives are to examine the relationships between bowel symptoms and selected lifestyle-related factors, particularly sleep duration, physical activity, and fluid intake. No therapeutic, pharmacological, exercise-based, or invasive intervention will be administered as part of the study.
Typ studiów
Zapisy (Szacowany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
The study population will consist of undergraduate university students aged 18 years or older who are enrolled in courses with final examinations during the study period. Eligible students who meet the predefined inclusion and exclusion criteria and voluntarily agree to participate will be included in the study.
Participants will be evaluated during the final examination period, which represents a naturally occurring period of academic stress. During this period, bowel-related symptoms and selected lifestyle factors, including sleep duration, daily step count, and water intake, will be assessed. Participants will also complete a 7-day follow-up diary to record daily bowel characteristics and related symptoms.
Opis
Inclusion Criteria:
- Being 18 years of age or older
- Being an undergraduate university student
- Being enrolled in courses with final examinations during the study period
- Being able to complete the study assessments and the 7-day follow-up diary during the final examination period
- Being able to read and understand Turkish
- Voluntarily agreeing to participate in the study and providing informed consent
Exclusion Criteria:
- Having a diagnosed organic gastrointestinal disease that may substantially affect bowel function, such as inflammatory bowel disease, celiac disease, or gastrointestinal malignancy
- Having a history of major gastrointestinal or pelvic surgery that may affect bowel function
- Regular use of medications that directly affect bowel motility, such as laxatives or antidiarrheal medications
- Having an acute gastrointestinal infection, including acute diarrhea or vomiting, during the assessment period
- Failing to adequately complete the study assessments or the 7-day follow-up diary
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: OTHER
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
University Students During the Final Examination Period
University students who meet the eligibility criteria and participate in the study during the final examination period will constitute a single observational cohort. Participants will undergo assessment of bowel symptoms and related lifestyle factors during the study period. No allocation or randomization will be performed. |
Participants will complete assessments of bowel symptoms and a 7-day diary during the final examination period. The diary will include daily records of bowel-related symptoms, stool characteristics, fluid intake, step count, and sleep duration. No treatment, medication, exercise program, or other therapeutic intervention will be administered. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Constipation-Related Bowel Symptoms
Ramy czasowe: Baseline
|
Constipation-related bowel symptoms will be assessed using Rome IV-based questions. The assessment (Rome IV criterias) will include defecation frequency, painful or difficult defecation, large-diameter stools, stool withholding behaviors, sensation of a large fecal mass in the rectum, fecal incontinence, and duration of symptoms. |
Baseline
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Defecation-Related Pain
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Participants will record the presence or absence of pain during defecation each day. When pain is present, its location (abdominal or anal region) and intensity will also be recorded. Pain intensity will be rated on a numerical scale ranging from 0 to 10, with higher scores indicating greater pain intensity. |
Daily for 7 consecutive days during the final examination period
|
|
Defecation Urgency
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Participants will record the severity of urgency to defecate each day as mild, moderate, or severe. |
Daily for 7 consecutive days during the final examination period
|
|
Stool Type
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Participants will record their daily stool type according to the stool form chart provided in the study diary. |
Daily for 7 consecutive days during the final examination period
|
|
Daily Step Count
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Daily step count will be recorded using data obtained from participants' personal smartphones, smartwatches, or other step-counting devices. The mean daily step count across the 7-day monitoring period will also be calculated and evaluated as a lifestyle-related factor potentially associated with bowel symptoms. |
Daily for 7 consecutive days during the final examination period
|
|
Sleep Duration
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Participants will record the total duration of sleep for each day in hours. The mean daily sleep duration across the 7-day monitoring period will be calculated and evaluated as a potential factor associated with bowel symptoms. |
Daily for 7 consecutive days during the final examination period
|
|
Daily Water Intake
Ramy czasowe: Daily for 7 consecutive days during the final examination period
|
Participants will record their total daily water intake in milliliters. The mean daily water intake across the 7-day monitoring period will be calculated and examined in relation to bowel symptoms. |
Daily for 7 consecutive days during the final examination period
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-FG
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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