- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034017
Gastroesophageal Reflux Disease Among College Students
Personal, Academic and Stress Correlates of Gastroesophageal Reflux Disease Among College Students in Southwestern Saudi Arabia: A Cross-sectional Study
Study Overview
Detailed Description
Study design and setting A cross-sectional study was carried out in both male and female campuses of King Khalid University (KKU) during the academic year 2018-2019. The University is located in Aseer region in the southwestern part of Saudi Arabia. The area of Aseer region is about 80.000 square kilometers occupied with more than 1.6 million people. The university comprise 5 health colleges and 24 non-health colleges with a total number of 60.312 male and female students in the academic year 2014-2015.
Target population Students in Health and non-health care colleges in KKU were the target population.
Sample size and sampling method Sample size was estimated by using Epi info program version 7.2 with the anticipated prevalence of GERD symptoms among college students 23.8% [6], 95% confidence level and acceptable margin of error of 2.5%. The calculated cluster size was 1113 students. To account for the possibility of non-response, 1200 students were targeted from each of health and non-health care colleges.
All health care colleges were included in the study. They were colleges of medicine, pharmacy, dentistry, nursing and applied medical science. Five non- health care colleges were selected by random method. They were colleges of education, science, humanities, administrative and financial sciences, and languages and translation. Participants were selected through stratified cluster sampling technique. Within each college, students were stratified by academic level. Within each level a cluster (section or study group) was selected. When possible, all registered students within each cluster were included.
Study tool and data collection A self-reported questionnaire was distributed personally by medical students-during their training in community medicine course- between the participants. The questionnaire includes the following sections: a) personal data such as, age sex, marital status, smoking status and family income; b) academic data which include, name of college, academic level and Grade point average (GPA); c) Arabic version of GERD questionnaire (GerdQ)[10]; d) Arabic version of Cohen's Perceived Stress Scale (PSS) [8].
All incomplete questionnaires were excluded. Arabic version of GERD questionnaire (GerdQ) GerdQ is a valid questionnaire used to explore the probaility of GERD. It is consisted of 6 questions as follow: four positive questions to assess GERD symptoms (heartburn, regurgitation, sleep disturbance related to heartburn and regurgitation and use of medications) and two negative questions (epigastric pain and nausea). Each item rated from 0 to 3 depending on the rate of symptoms over the previous week. GERD was detected with a total score value of 8 or more [10]. Score value of 8 or more plus total score value of 3 or more for the impact questions (sleep disturbance and use of medications) indicted GERD with impact on daily life. The Arabic version of GerdQ was developed and validated for use among Arabic speakers [11].
Data analysis The gained data were entered, revised, and analyzed using SPSS, version 22 software package. Grading of PSS into low, moderate and high was according to Cohen's et al [12]. Crude odds ratio (cOR) and adjusted odds ratio (aOR) were calculated using univariate and multivariable logistic regression analysis respectively. Their 95% confidence intervals (95% CIs) were used to identify significant factors associated with GERD among students.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aseer
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Abha, Aseer, Saudi Arabia, 61421
- King Khalid University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- College students
- Must be cooperative
- Agree to participate
Exclusion Criteria:
- non cooperative students
- disagree to participate in the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence rate of gastroesophogeal reflux disease (GERD) among college students
Time Frame: 1 year
|
Arabic version of GERD questionnaire (GerdQ) was used to screen for GERD among college students.
GERD was considered with a total score value of GerdQ of 8 or more
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1 year
|
assess the association of GERD with students' personal data
Time Frame: 1 year
|
examining the associations of GERD with the personal data such as, age (in years) sex (male Vs. female), marital status (married Vs. single), smoking status (smoker, ex-smoker and non-smoker) and family income (sufficient Vs. insufficient)
|
1 year
|
assess the association of GERD with students' academic data
Time Frame: 1 year
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the academic data include: college(health care Vs. non-health care colleges) academic year (first year through six year) student's Grade point average (GPA) in the previous academic year
|
1 year
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examine the association of GERD with the level of perceived stress
Time Frame: 1 year
|
perceived stress was assessed by using the Arabic version of Cohen's Perceived Stress Scale (PSS).
Grading of PSS into low, moderate and high was done as the following: scores ranging from 0-13 was considered low stress; scores ranging from 14-26 was considered moderate stress; scores ranging from 27-40 was considered high perceived stress.
|
1 year
|
Collaborators and Investigators
Sponsor
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
- ECM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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