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Nursing Teaching Scheme for Patients With Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nursing Teaching
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastroesophageal Reflux Disease focused on measuring Compliance, Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Clinical diagnosis of gastroesophageal reflux disease Exclusion Criteria: Peptic ulcer Esophageal cancer Esophageal surgery Pregnant women

Sites / Locations

  • Faculty of Nursing Assiut University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one group pre- test post- test

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Symptoms of Gastroesophageal Reflux Disease
Gastro-esophageal Reflux Disease Questionnaire. It is composed of 6 items and uses a four-graded Likert scale (0-3) to score four positive predictors of GERD (heartburn, regurgitation, sleep disturbance due to reflux symptoms, and over the medications for reflux symptoms) and a reversed Likert scale (3-0) for two negative predictors (epigastric pain and nausea), giving a total GERD score range of 0-18. The maximum score that can be obtained is 18 divided as follows mild (0- 6), moderate (7- 12) and sever (13-18)

Secondary Outcome Measures

Compliance with Medication
Mourisky Medication Adherence Scale (MMAS) It a structured self-reported 8 closed-end items response. Each response will be scored as (zero) for "no" and (one) for "yes". The total score will be calculated and the result will be categorized into two groups; the patient whose less than 4 will be categorized as non-adherent while whose score 4-8 will be categorized as adherence

Full Information

First Posted
June 20, 2023
Last Updated
July 10, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05937204
Brief Title
Nursing Teaching Scheme for Patients With Gastroesophageal Reflux Disease
Official Title
Nursing Teaching Scheme to Improve Remedial Compliance and Alleviate Symptoms Among Patients With Gastro-esophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aims of the study are: Assess patient's level of knowledge regarding gastroesophageal reflux disease. Assess patient' compliance and symptoms of gastroesophageal reflux disease. Design and implement nursing teaching scheme for patients with gastroesophageal reflux disease. Evaluate the effect of nursing teaching scheme on patient' compliance and symptoms of gastroesophageal reflux disease.
Detailed Description
Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders, which resulting from a retrograde flow of part of the gastroduodenal contents into the esophagus. Generally, this reflux is linked to a malfunction of the lower esophageal sphincter .A recent study stated that the prevalence of GERD is 18,1- 27.8% in North America, 8,8-25,9% in Europe, 2,5-7,8% in East Asia, 8,7-33,1% in middle east, 11.6% in Australia, and 23% in South America, on the other hand according to a study in Indonesia, about 3% in Asia. Many factors may contribute to the development of the disease. Among them, there are non-modifiable factors such as age, sex or genetic factors and modifiable factors, e.g. smoking, alcohol, obesity, aspirin, non-steroidal anti-inflammatory drug (NSAID) use, pregnancy. Furthermore, spicy, sour, and fatty foods can caused a direct esophageal mucosal irritation also reduction in lower esophageal sphincter (LES) tone and gastric motility. The classical symptoms of GERD are heartburn (a retrosternal burning pain radiating up towards the throat) and acid regurgitation (the perception of stomach contents coming into the hypopharynx or mouth). Atypical symptoms may also occur (including globous, chest pain, dysphagia, cough, nausea, and throat symptoms or belching). Recurrent and chronic exposure of the esophageal epithelia to the strong acidity of the refluxed material may cause esophagitis. If untreated, the disease can lead to complications such as esophageal stricture, gastrointestinal bleeding, precancerous conditions (Barrett's Esophagus ) and esophageal adenocarcinoma .Management of GERD can involve medication use, lifestyle modification, and surgical intervention depending on the individual patient and disease severity . Lifestyle interventions commonly recommended include dietary modification, weight management, smoking cessation, and head of bed elevation while recumbent and voiding recumbence at least 3 hours postprandial. The Mediterranean diet (MD) is mainly based on the regular consumption of vegetables, legumes, cereals, fruit and nuts, and the moderate consumption of fish and seafood, balanced by a comparatively limited use of red meat and other meat products, most of them cooked with olive oil as the main source of dietary fat, together with low-to-moderate alcohol consumption This diet has also been associated with a healthy lifestyle as regular physical activity and not smoking. Emerging data indicates that appropriate eating habits e.g., healthy diets involving high intakes of fruits and whole grains such as the Mediterranean diet improves GERD symptoms. Therefore, improving diets can decrease the occurrence of GERD. The crural diaphragm is one of the main components of the esophagogastric junction and plays an important role in preventing gastroesophageal reflux. The diaphragm, as a skeletal muscle, is partially under voluntary control and its dysfunction can be improved via breathing exercises. Thus, diaphragmatic breathing training (DBT) has the potential to alleviate symptoms in patients with GERD. teaching patients to do diaphragmatic breathing exercises could reduce their gastric reflux symptoms and increase their quality of life over time. Thus, diaphragmatic breathing exercises are recommended to be used as a part of these patients' treatment programs. Patient teaching has been shown to be beneficial for a variety of diseases. Patients with gastroesophageal reflux disease have wide range of unpleasant symptoms as heartburn, regurgitation so, teaching patient strategies to alleviate symptoms is important aspect .teaching is a known predictor for increased engagement in shared decision making, improved medication and treatment adherence, higher levels of satisfaction, and even better treatment outcomes. Operational definitions: Nursing teaching scheme: A nursing teaching scheme refers to a systematic and structured plan developed by nurses to provide teaching and instruction to patients. The components of a nursing teaching scheme typically include assessing learning needs, setting learning objectives, developing teaching materials, delivering information using various teaching methods, demonstrating skills, providing written instructions, assessing learning outcomes, and conducting follow-up Remedial compliance: Compliance is defined by the World Health Organization as "the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Compliance, Symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one group pre- test post- test
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Nursing Teaching
Intervention Description
A nursing teaching scheme refers to a systematic and structured plan developed by nurses to provide teaching and instruction to patients. The components of a nursing teaching scheme typically include assessing learning needs, setting learning objectives, developing teaching materials, delivering information using various teaching methods, demonstrating skills, providing written instructions, assessing learning outcomes, and conducting follow-up
Primary Outcome Measure Information:
Title
Change from Baseline in Symptoms of Gastroesophageal Reflux Disease
Description
Gastro-esophageal Reflux Disease Questionnaire. It is composed of 6 items and uses a four-graded Likert scale (0-3) to score four positive predictors of GERD (heartburn, regurgitation, sleep disturbance due to reflux symptoms, and over the medications for reflux symptoms) and a reversed Likert scale (3-0) for two negative predictors (epigastric pain and nausea), giving a total GERD score range of 0-18. The maximum score that can be obtained is 18 divided as follows mild (0- 6), moderate (7- 12) and sever (13-18)
Time Frame
"4Weeks"
Secondary Outcome Measure Information:
Title
Compliance with Medication
Description
Mourisky Medication Adherence Scale (MMAS) It a structured self-reported 8 closed-end items response. Each response will be scored as (zero) for "no" and (one) for "yes". The total score will be calculated and the result will be categorized into two groups; the patient whose less than 4 will be categorized as non-adherent while whose score 4-8 will be categorized as adherence
Time Frame
"4Weeks"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Clinical diagnosis of gastroesophageal reflux disease Exclusion Criteria: Peptic ulcer Esophageal cancer Esophageal surgery Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa mahmoud Goumaa mahmoud, assistant lecturer
Phone
01129102864
Email
asmaa_mahmoud@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed medhat, assistant professor
Phone
01000493632
Email
mohammed.medhat@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shalabia elsayed abuozead, professor
Organizational Affiliation
faculty of nursing - assiut university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nursing Assiut University
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
samya Yousef sayed
Phone
01033390314
Email
samya.mohamed@nursing.aun.edu.eg
First Name & Middle Initial & Last Name & Degree
asmaa mahmoud goumaa, assistant lecturer

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37094911
Citation
Fox M, Gyawali CP. Dietary factors involved in GERD management. Best Pract Res Clin Gastroenterol. 2023 Feb-Mar;62-63:101826. doi: 10.1016/j.bpg.2023.101826. Epub 2023 Feb 17.
Results Reference
result

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Nursing Teaching Scheme for Patients With Gastroesophageal Reflux Disease

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