The present study aims to evaluate patients' self-care behavior about Gastroesophageal Reflux Disease based on the self-care model in addition to determine the effectiveness of educational program on patients' knowledge about gastroesophageal reflux disease.
Design
Quasi-experimental design through the use of pre and post-tests for the study sample
Settings and conduct
AL-Najaf Health Directorate in Specialized Hospital for Gastrointestinal and Liver Diseases and Surgery
Participants/Inclusion and exclusion criteria
1. Patients of Arabic Nationality
2. Free from psychological or intellectual disorder
3. Age: ≥20 year.
4. Sex: Both males and females.
5. Who are agree to participate in the study.
6. Patients who will be able to communicate.
7. Patients who diagnosed as GERD.
Intervention groups
educational program about self care
Main outcome variables
self-care of patient with GERD
General information
Reason for update
Acronym
Educational Program trial
IRCT registration information
IRCT registration number:IRCT20231115060062N1
Registration date:2024-03-09, 1402/12/19
Registration timing:registered_while_recruiting
Last update:2024-03-09, 1402/12/19
Update count:0
Registration date
2024-03-09, 1402/12/19
Registrant information
Name
Bashar Rasheed
Name of organization / entity
University of Kufa
Country
Iraq
Phone
+964 780 477 2324
Email address
bashar.rasheed@uokufa.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-30, 1402/09/09
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of an Educational Program on Patients' Knowledge about Gastroesophageal Reflux Disease: Self-care Model
Public title
Educational for Patients with Gastroesophageal Reflux Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients of Arabic Nationality
Free from psychological or intellectual disorder
Age: ≥18year.
sex: Both males and females.
Who are agree to participate in the study
Patients who will be able to communicate.
Patients who diagnosed as GERD
Exclusion criteria:
psychological patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Baghdad nursing college
Street address
Najaf
City
Najaf
Postal code
00964
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
10
Health conditions studied
1
Description of health condition studied
patient with gastroesophageal reflex diseases
ICD-10 code
K21.0
ICD-10 code description
Gastro-esophageal reflux disease with esophagitis
Primary outcomes
1
Description
To evaluate patients' self-care about Gastroesophageal Reflux Disease based on the self-care model.
Timepoint
pre intervention and 3-month post intervention
Method of measurement
Questionanner (The Mindful Self-Care Scale- SHORT)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will undergo a total educational program consisting of six sessions (every session per week), providing self-care education for participants, with each session lasting approximately 45 minutes. The researcher will employ pre and posttests to assess the patients' self-care lifestyle before and after the application of the program. Various teaching materials will be utilized, including presentations, educational films, photos, and brochures. These resources aim to furnish patients with medical information enabling them to recognize gastroesophageal reflux and its associated risk factors. The educational objectives encompass enabling patients, post-lecture, to identify the disease, comprehend its causes, risk factors, symptoms, potential complaints, as well as familiarize them with diagnostic tests, disease complications, and strategies for managing it. Moreover, the researcher will explain lifestyle habits, encompassing physical activity and unhealthy practices like smoking, alcohol consumption, medication use, and stress management. The primary goal is to augment patient knowledge regarding exercise, the avoidance of unhealthy habits, and stress management that can exacerbate the disease. Patients will also learn how to exercise effectively, avoid unhealthy habits, reduce stress, and adhere to medication schedules to mitigate potential complications.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
1
Full name of responsible person
Mahmmod Al-kindy
Street address
Najaf
City
Najaf
Postal code
00964
Phone
+964 780 477 2324
Fax
Email
bashar.rasheed@uokufa.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
university of Baghdad
Full name of responsible person
University of Baghdad nursing college
Street address
Najaf
City
Najaf
Postal code
00964
Phone
+964 780 477 2324
Email
bashar.rasheed@uokufa.edu.iq
Grant name
university of Baghdad
Grant code / Reference number
40
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university of Kufa
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
university of Baghdad
Full name of responsible person
Hussein Hadi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Najaf
City
Najaf
Province
Najaf
Postal code
00964
Phone
+964 780 477 2324
Email
bashar.rasheed@uokufa.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
The university of Baghdad
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Najaf
City
Najaf
Province
Najaf
Postal code
00964
Phone
+964 780 477 2324
Email
bashar.rasheed@uokufa.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Bashar Rashhed
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Najaf
City
Najaf
Province
Najaf
Postal code
00964
Phone
+964 780 477 2324
Email
bashar.rasheed@uokufa.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Effectiveness of an Educational Program on Patients' Knowledge about Gastroesophageal Reflux Disease: Self-care Model
When the data will become available and for how long
3 month to application program
To whom data/document is available
academic researchers
Under which criteria data/document could be used
this data used to compare with other research
From where data/document is obtainable
Bashar Rasheed
What processes are involved for a request to access data/document