Determining the effect of the educational program on the knowledge and care performance of parents of children with congenital heart defects
Design
The clinical trial has a control group, with parallel groups, the samples will be randomly divided into two groups test (N=43) and control (N=43) using a random replacement blocks.
Settings and conduct
The research sample in this study includes 86 parents (fathers or mothers) of children with congenital heart abnormalities. The research environment is hospitals affiliated to Jundishapur University of Medical Sciences in Ahvaz. For the test group (43 people), combined educational intervention (face-to-face and showing an educational film approved by the doctor and performing physical activities in a practical way under the supervision of the researcher) by the researcher during 6 sessions of 45 minutes (one session per week) will be executed.
No educational intervention will be done for the control group.
Participants/Inclusion and exclusion criteria
Registration and certainty of the diagnosis of congenital heart abnormality in the child's medical record؛ Children in the age group of one month to twelve years؛ Parents have not participated in educational groups before؛ Parents should have mental and intellectual skills to complete the questionnaire and participate in the educational program.
Intervention groups
For the test group (43 people), combined educational intervention by the researcher during 6 sessions of 45 minutes (one session per week) will be executed. No educational intervention will be done for the control group.
Main outcome variables
Parental Knowledge؛ Parental care performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220912055950N1
Registration date:2022-09-24, 1401/07/02
Registration timing:prospective
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Najmeh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 1728
Email address
hoseiny.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program on the knowledge and care performance of parents of children with congenital heart disorders
Public title
The effect of educational program on the knowledge and care performance of parents of children with congenital heart disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Registration and certainty of diagnosis of congenital heart abnormality in the child's medical record.
Parents of children from one month to twelve years old.
Parents have not participated in educational groups before.
Parents must have the mental and intellectual ability to complete the questionnaire and participate in the educational program.
Exclusion criteria:
Absence of more than one session in training classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly divided into two intervention and control groups using the random permutation block method (using the table of random permutation blocks).
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
Ethics committees of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences., Golestan St., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6136939305
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.AJUMS.REC.1401.251
Health conditions studied
1
Description of health condition studied
Congenital heart disorders
ICD-10 code
XIII
ICD-10 code description
Congenital malformations, deformations and chromosomal abnormalities
Primary outcomes
1
Description
The level of knowledge and care performance of parents with children with congenital heart disorders
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
Researcher-made questionnaire (measurement of knowledge and care performance)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, the combined educational program (face-to-face and educational film screening approved by the doctor and practical physical activities under the supervision of the researcher) will be implemented by the researcher during 6 45-minute sessions (one session per week).
Category
N/A
2
Description
Control group: No educational intervention will be done for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
AshrafalSadat Hakim
Street address
Golestan Hospital, Farvardin St., Golestan Blvd
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
AshrafalSadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Hakim3448200@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
AshrafalSadat Hakim
Position
Assistant professor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Hakim3448200@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
AshrafalSadat Hakim
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
hakim3448200@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available