Determining the effect of group training of parents on controlling the recurrence of convulsive attacks in children
Design
Sampling will be done by random sampling method. The clinical trial has a control group, with parallel groups, not blinded, a study on 72 patients, and the samples will be randomly placed in two control groups (N=36) and test group (N=36) by permutation method. The design of this plan is parallel.
Settings and conduct
The research sample includes 72 children from 6 months to 5 years with seizures. The research environment is teaching hospitals affiliated to Ahvaz University of Medical Sciences. For the test group the educational intervention will be conducted in face-to-face and showing an educational film approved by the doctor and presentation of an educational pamphlet by the researcher during 10 sessions of 45 minutes one session per week.For the control group No educational intervention will be done.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include:1.Children with seizures must be between six months and five years old 2.parents must have minimum reading and writing literacy or the mental and intellectual ability to participate in educational programs and complete the questionnaire؛The conditions for leaving study include:1.parents' unwillingness to participate in the research 2.parents suffering from physical or mental disorders based on self-report 3.parents' non-participation in 2 training sessions
Intervention groups
For the test group , the educational intervention will be conducted in face-to-face and showing an educational film approved by the doctor and presentation of an educational pamphlet by the researcher during10 sessions of 45 minutes one session per week.For the control group No educational intervention will be done.
Main outcome variables
Seizure control rate in children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230709058732N1
Registration date:2023-07-24, 1402/05/02
Registration timing:registered_while_recruiting
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Niloofar Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4353 8053
Email address
niloofareskandariiii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group education of parents on controlling the recurrence of seizure attacks in children 6 months to 5 years
Public title
The effect of group education on controlling of seizure attacks in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The main conditions for entering the study before randomization include: 1. Having an age of six months to five years for children with seizures
2. Parents must have minimum reading and writing literacy or mental and intellectual ability to participate in educational programs and complete the questionnaire
Exclusion criteria:
Parents' unwillingness to participate in the research
Parents suffering from physical or mental disorders based on self-report
Parents' non-participation in 2 training sessions.
Age
From 6 months old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
36
36 people in the control group and 36 people in the test group
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were first selected from 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 permutation blocks of four (using the table related to random blocks). In this method, the people assigned to each group are equal. The blocks are formed based on the desired variables and half of the people in each block are included as intervention and half as control. The main goal is to balance the number of participants in each group.
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
University of Medical Science., Esfand Street., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.AJUMS.REC.1402.215
Health conditions studied
1
Description of health condition studied
Seizure (convulsive)
ICD-10 code
R56.8
ICD-10 code description
Seizure (convulsive) NOS
Primary outcomes
1
Description
Seizure (convulsive)
Timepoint
Before the start of the intervention and one month after the intervention
Method of measurement
A combined questionnaire including a researcher-made questionnaire and an original questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the test group, educational intervention in the form of (face-to-face and showing educational videos and educational sessions approved by the doctor) will be carried out by the researcher during 10 sessions of 45 minutes, 1 session per week. In order to apply the educational method, the educational content is prepared based on the educational goals and by using authentic books and consultation with a doctor specializing in seizures. Educational content will be presented to parents first through face-to-face method and then through videos and other educational methods during training sessions.The educational content includes the definition of seizures, classification and types of seizures (simple, complex), duration of each type of seizure, symptoms of seizures, probability of recurrence, causes and risk factors of seizures, complications caused by seizures, treatment methods, drugs and methods Taking medicines, feeding the child, in case of fever, fever control methods, the correct method of application, ways to prevent convulsions and education about convulsion-accelerating factors (flashing light, lack of sleep, excessive activity, exercise, physical factors).Among other things, teaching precautions at home, interventions during seizures (the correct position of the child during an attack, removing tight and restricting clothes, giving the opportunity to perform spontaneous convulsive movements, not putting anything in the child's mouth, not trying to restrict sedating the child, using suppositories, calling the emergency center if the seizure lasts more than five minutes or repeats the attacks or the child's lack of consciousness after stopping the convulsive movements. After the intervention, a checklist will be provided to parents to check their performance at home to control children's seizures within a month.
Category
Behavior
2
Description
Control group: No educational intervention will be done for the control group, but in order to comply with the ethical points, pamphlets and educational booklets will be provided to the control group after the analysis of the study results.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Dhar Hospital
Full name of responsible person
Ashraf al-Sadat Hakim
Street address
Abu Dhar Hospital., Nurse Street., Pasdaran Blvd., Zeitun Karmani., Ahvaz City
City
Ahvaz
Province
Khouzestan
Postal code
6163614174
Phone
+98 61 3444 9003
Email
jamileh192 @ ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ashraf al-Sadat Hakim
Street address
Golestan Hospital., Farvardin Street., Golestan Blvd., Ahvaz City
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Golestanhospital@ ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology, Dr. Mehrnoosh Zakirkish