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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178877
Other study ID # 16-11-430
Secondary ID
Status Completed
Phase N/A
First received June 3, 2017
Last updated June 5, 2017
Start date November 1, 2016
Est. completion date December 31, 2016

Study information

Verified date June 2017
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 30 Years
Eligibility 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 Design


Intervention

Other:
No intervention


Locations

Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety and depression Anxiety and Depression using Hospital Anxiety Depression Scale 1 month
Secondary Sleep Quality Sleep quality using Pittsburg Sleep Quality Index 1 month
Secondary Spiritual status Spiritual status using Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing 1 month
Secondary Academic Stress Academic stress using Student-Life Stress Inventory 6 months
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