- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178877
The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors (IBS)
June 5, 2017 updated by: Ari Fahrial Syam, Indonesia University
A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016.
This study used stratified randomized sampling.
The Rome IV criteria was used for diagnosing IBS.
Questionnaire-guided interview was applied to all subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016.
This study used stratified randomized sampling.
The Rome IV criteria was used for diagnosing IBS.
Questionnaire-guided interview was applied to all subjects.
A bivariate analysis was done to know the relationship between IBS and its related factors using chi-square, unpaired t-test, and their alternatives.
Multivariate analysis was done using logistic regression test
Study Type
Observational
Enrollment (Actual)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Medical student from first grade to fifth grade
Description
Inclusion Criteria:
- Age of participant >= 15 years
- Volunteer to participate in study
Exclusion Criteria:
- Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
- Diagnosed as having Inflammatory bowel disease
- Peptic ulcer drug consumption
- History of gastrointestinal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IBS
IBS group is medical student who filled Rome IV criteria for IBS
|
|
Non IBS
Non-IBS group is non IBS medical student based on Rome IV criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression
Time Frame: 1 month
|
Anxiety and Depression using Hospital Anxiety Depression Scale
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: 1 month
|
Sleep quality using Pittsburg Sleep Quality Index
|
1 month
|
Spiritual status
Time Frame: 1 month
|
Spiritual status using Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing
|
1 month
|
Academic Stress
Time Frame: 6 months
|
Academic stress using Student-Life Stress Inventory
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
June 3, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 5, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-11-430
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not available to other researcher
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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