Prevalence of GERD, Its Effect on HRQL and Psychological Disturbance, and the Effect of Eating Behaviors on GERD Prevalence

NCT07164274 | Active Not Recruiting

• 1 other identifier: ZU-IRB# 1580/5-Aug-2025
• Study Type: observational
• Target: 3,773
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease. It is a chronic condition that is characterized by the regurgitation of stomach contents into the esophagus and is associated with heartburn. The occurrence of these symptoms for at least two weeks increases the likelihood of having GERD. Other GERD symptoms include chest pain, nausea, dysphagia, burping, water brash, and vomiting. All these symptoms negatively affect the patients' quality of life. The pathophysiology of GERD is multifactorial. Several factors have been suggested to cause GERD, including a hypotensive lower esophageal sphincter (LOS) and a defect in the gastric sling/clasp muscle fiber component. The global prevalence of GERD is about 13.98% with variation among different countries and ethnic groups. In East Asia, it ranges from 2.5% to 7.5%, 8.5 to 25.9% in Europe, 18.1% to 27.8% in South and North America, and about 11.6% in Australia. In the Middle East, it ranges from 8.7% to 33.1%. Several risk factors have been identified that increase the likelihood of having GERD. Obesity was found to be one of the risk factors that increases GERD. Also, dietary habits such as spicy food, coffee drinks, or administering NSAIDs increase the prevalence of having GERD. On the other hand, psychological factors also play an important role in GERD severity. Both stress and anxiety are linked to an increase in GERD. A previous study showed that stress can increase heartburn symptoms in patients with heartburn and also increase in anxiety level was associated with an increase in esophageal reflux. Finally, depression was found to be associated with GERD, which can be explained by a change in the eating behavior in depressed patients. Rationale Medical students suffer from a study burden, which increases their level of anxiety and stress. They also have a higher likelihood of having trouble with eating behavior or having a lot of coffee daily. This increases their likelihood of having GERD. In the Middle East, fewer studies have assessed the effect of GERD. A recent cross-sectional study assessed the prevalence of GERD among medical students in Egypt. They found a prevalence of 17.1%. They found an association between increasing stress levels and increasing GERD severity. Also, smoking was a significant risk factor for GERD symptoms. Another cross-sectional study among medical students in 21 universities in Egypt. They reported a prevalence of 28.4%. Again, they found that an increasing level of stress and anxiety was associated with increasing GERD severity. Finally, Two cross-sectional studies were conducted in Saudi Arabia. They reported a prevalence of 23.8% and 23.1% respectively. To our knowledge, no study has assessed the GERD and its related quality of life among medical students in Middle East and linked their findings with eating behaviour

Conditions

Gastro -Oesophagal Reflux; Eating Behavior Disorders

Outcome Measures

Primary Outcomes (2)

• GERD prevalence

  The GERDQ questionnaire will be used. It is composed of 6 Likert scale questions that ask about GERD symptoms such as heartburn, nausea, and regurgitation. Each question has 4 answers scored from 0 to 3, making a rank from 0 to 18. If the participant scores 8 or more, this diagnosis is GERD. Furthermore, the severity can be assessed. A score of 0-2 makes 0 % of having GERD, 3-7 makes a 50% likelihood of having GERD, 8-10 makes a 79% and 11-18 makes a 89% of having GERD. This questionnaire has a sensitivity being 65% and a specificity being 71% to diagnose GERD

  through study completion, an average of 6 months

• GERD_HRQL

  The GERD-HRQL was used. This is a 16 Likert scale questionnaire that asks about the effect of GERD symptoms on the quality of life. The first 15 questions had 6 answers, ranging from no symptoms to Symptoms that are incapacitating - unable to do daily activities. This score ranges from 0 to 5. The sixteenth question asks about the present condition. The quality of life is calculated via the first 15 questions (scores from 0 to 75), with higher scores indicating lower quality of life.

  through study completion, an average of 6 months

Secondary Outcomes (2)

• Eating behavior disorder

  through study completion, an average of 6 months

• Psychological disturbance

  through study completion, an average of 6 months

Interventions

Questionnaire OTHER

An online questionnaire that will be shared via online platforms for medical students and interns in the Middle East countries to fill.

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Medical students and interns in the Middle East countries

You may qualify if:

• Medical students and interns studying medicine in the Middle East countries
• Have access to online platforms

You may not qualify if:

• Students or interns who refused to participate

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Medicine and Affiliated Hospital

Zagazig, Egypt

Location

Related Publications (1)

• Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.

  PMID: 19737151 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: August 5, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

EG (1)