Determining the comparison of the effectiveness of drug and non-drug treatment through group training on the control of esophageal reflux in children
Design
Sampling will be done with a sequential non-probability method. With a control group, with parallel groups, the samples will be randomly divided into two test groups (N=56) and control (N=56) using the randomized permutation method.
Settings and conduct
The research sample includes 112 infants aged 12 months to 3 years with esophageal reflux. The research environment is teaching hospitals affiliated to Ahvaz University of Medical Sciences. In the test group (56 people), the educational intervention will be implemented in a combined form (face-to-face and showing an educational film approved by the doctor and presenting a pamphlet) by the researcher during 6 45-minute sessions (one session per week). For the control group, no educational intervention. will not be done.
Participants/Inclusion and exclusion criteria
1-Having a child with esophageal reflux
2. Child age between 12 months and 3 years.
3- Not having a history of uncontrolled underlying disease
4- Parents have the ability to receive education (at least elementary literacy level)
5-lack of parents participating in the previous class
non criteria:
1.Children below 12 months and above three years.
2.Lack of proficiency in Persian language.
Intervention groups
For the test group, the educational intervention will be conducted in a combined form (face-to-face and showing an educational film approved by the doctor and presentation of a pamphlet) by the researcher during 6 45-minute sessions (one session per week). No educational intervention will be done for the control group.
Main outcome variables
The Level of control of esophageal reflux in children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221104056396N1
Registration date:2023-01-25, 1401/11/05
Registration timing:prospective
Last update:2023-01-25, 1401/11/05
Update count:0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Ashraf Al sadat Hakim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2392
Email address
hakim3448200@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2023-05-08, 1402/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of drug and non-drug treatment through group training on esophageal reflux control in children 12 months to 3 years
Public title
Investigating the effect of group training on the control of esophageal reflux in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with esophageal reflux.
Child age between 12 months and 3 years
Not having a history of uncontrolled underlying disease
parents have the ability to receive education (at least elementary literacy level)
Lack of parents' participation in the previous class
Exclusion criteria:
Children below 12 months and above three years
Lack of proficiency in Persian language
Age
From 12 months old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were first selected from among the research community based on the inclusion criteria. The random assignment of the research sample to two intervention and control groups will be done based on quadruple permutation blocks (using the table related to random permutation blocks, of Twenty-eight groups of four). In this method, the number of people assigned to each group is almost equal. Blocks are formed based on the variables in question, and half of the intervention people and half of the control people are included in each block. The main goal is to balance the number of participants in each group. is
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences, Ahvaz
Street address
Golestan Boulevard. Esfand Street, University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.AJUMS.REC.1401.271
Health conditions studied
1
Description of health condition studied
Esophageal reflux
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Esophageal reflux
Timepoint
Before the start of the intervention and two months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the non-pharmacological treatment group, in order to educate the parents, educational sessions will be held in the form of group discussions, during which the parents will be divided into groups of 5-6 people. And the side effects, the child's nutrition and position, and physical and emotional needs will be carried out by the researcher during 6 sessions of 45 minutes (one session per week), and at the end of the training sessions, an educational pamphlet will be provided to them.
Category
Behavior
2
Description
In the control group, no educational intervention will be done: the medical treatment of esomeprazole tablets is prescribed by the doctor, once a day for 6 months. However, in order to comply with ethical considerations, after analyzing the results, the educational pamphlet will be delivered to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Dhar Hospital
Full name of responsible person
Ashrafalsadat Hakim
Street address
Ahvaz Zaytoon Karmani. Pasdaran Blvd. Nurse Street. Abu Dhar Hospital