Gastroesophageal Reflux DiseaseNCT05937204
Nursing Teaching Scheme for Patients With Gastroesophageal Reflux Disease
A study testing Nursing Teaching in people with Gastroesophageal Reflux Disease, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Nursing Teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of gastroesophageal reflux disease
Who cannot join
- Peptic ulcer
- Esophageal cancer
- Esophageal surgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Nursing Assiut University
Asyut
samya Yousef sayed, 01033390314, samya.mohamed@nursing.aun.edu.eg
asmaa mahmoud goumaa, assistant lecturer
About this study
Official title: Nursing Teaching Scheme to Improve Remedial Compliance and Alleviate Symptoms Among Patients With Gastro-esophageal Reflux Disease
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.
Read the 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
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Nursing Teaching
- Keywords
- Compliance, Symptoms
- Medical subject headings
- Gastroesophageal Reflux, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing TeachingOther
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
| Study group | Role | What they receive |
|---|---|---|
| one group pre- test post- test | Experimental | Not described Receives: Other: Nursing Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "4Weeks"
Secondary outcomes (1)
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
Measured: "4Weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa mahmoud goumaa mahmoud, Assiut University
- Investigators
- shalabia elsayed abuozead, professor, Study chair, faculty of nursing - assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937204
- Sponsor's protocol ID
- nursing teaching scheme - GERD
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37094911
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Teaching Scheme to Improve Remedial Compliance and Alleviate Symptoms Among Patients With Gastro-esophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05937204
- Acronym / sponsor ID
- nursing teaching scheme - GERD
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Compliance, Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group pre- test post- test | Experimental | Other: Nursing Teaching |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of gastroesophageal reflux disease
Key exclusion criteria (4 listed)
- Peptic ulcer
- Esophageal cancer
- Esophageal surgery
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing TeachingA 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 | Other | one group pre- test post- test |
Primary outcome
Change from Baseline in Symptoms of Gastroesophageal Reflux Disease
Time frame: "4Weeks"
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)
1 secondary outcome
Compliance with Medication
Time frame: "4Weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Results publication: PubMed 37094911Fox 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.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shalabia elsayed abuozead, professor study chair
faculty of nursing - assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Teaching in people with Gastroesophageal Reflux Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa mahmoud Goumaa mahmoud, assistant lecturer (01129102864, asmaa_mahmoud@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Symptoms of Gastroesophageal Reflux Disease (time frame: "4Weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.