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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Asmaa mahmoud Goumaa mahmoud, assistant lecturer contact

01129102864

asmaa_mahmoud@aun.edu.eg

Mohamed Ahmed medhat, assistant professor contact

01000493632

mohammed.medhat@aun.edu.eg

Egypt1 site
  • Faculty of Nursing Assiut University

    Asyut

    samya Yousef sayed, 01033390314, samya.mohamed@nursing.aun.edu.eg

    asmaa mahmoud goumaa, assistant lecturer

Other trials in Egypt

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

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 groups in NCT05937204
Study groupRoleWhat they receive
one group pre- test post- testExperimentalNot described
Receives: Other: Nursing Teaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted10 Jul 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

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)
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

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.

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