Determine the effect of combination of individual and multimedia education on quality of life of school-aged children with congenital heart defects.
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
Sixty patients referred to the pediatric cardiology clinic of Imam Reza Hospital in Mashhad, based on inclusion criteria, will be randomly assigned (blocking) to the intervention or control group without the knowledge in which group they are in. Quality of life questionnaire of a child with congenital heart disease will complted for both group before and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness of the child to participate in the research and permission of his parent; age of the child between 8-12 years old; the child's ability to read and speak Persian; diagnosis of congenital heart disease at a younger age; not mentally retarded; child with congenital heart disease (cyanotic and non-cyanotic); age of diagnosis in preschool child (from infancy to toddler); having a smartphone; no diagnosis of other heart diseases. Exclusion criteria: child and parent withdrawal from cooperation; event in the patient's individual or family life during intervention that affects the quality of life, such as the death of a parent.
Intervention groups
In intervention group, first, an 80-minute face-to-face education session will be held in the presence of parents and children. After that educational package that includes short videos which played in in a face-to-face session will be available for patients. In control group, participants will receive routine hospital training in the form of an educational pamphlet that includes explanations of illness, treatment, and nutrition.
Main outcome variables
Quality of life score in the quality of life questionnaire of a child with congenital heart disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211017052789N1
Registration date:2021-11-11, 1400/08/20
Registration timing:prospective
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
Atousa Dezhraftar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
dezhra2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
2021-12-16, 1400/09/25
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-04-19, 1401/01/30
Scientific title
The effect of combination of individual and multimedia education on quality of life of school-aged children with congenital heart defects
Public title
The effect of combination of individual and multimedia education on quality of life of school-aged children with congenital heart defects
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the child to participate in the research and permission of his parent
Age of the child between 8-12 years old
The child's ability to read and speak Persian
Diagnosis of congenital heart disease at a younger age
Not mentally retarded
Child with congenital heart disease (cyanotic and non-cyanotic)
Age of diagnosis in preschool child (from infancy to toddler)
Having a smartphone
No diagnosis of other heart diseases
Exclusion criteria:
Child and parent withdrawal from cooperation
An event in the patient's individual or family life during intervention that affects the quality of life, such as the death of a parent
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, the allocation of samples to test or control groups will be done by random allocation (using blocking).
The use of blocking will be done on different days due to the allocation of samples. In this method, the groups are first identified by giving the code to the groups that will be group A: intervention and B: control. 5 blocks of 6 are specified: 1- AABBAB, 2- BBAABA, 3-AABABB, 4-BABABA, 5-BBBAAA, 6- AAABBB. Finally, they are included in the study and placed in the intervention and control groups, respectively. After completing the first 5 blocks, the second block will be sampled.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be informed about which group they will be in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of School of Nursing & Midwifery, Mashhad University of Medical Sciences
Street address
Nursing and Midwifery school, Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2021-05-18, 1400/02/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.024
Health conditions studied
1
Description of health condition studied
Congenital Heart Disease
ICD-10 code
Q24. 9
ICD-10 code description
Congenital malformation of heart, unspecified
Primary outcomes
1
Description
Quality of life score in the quality of life questionnaire of a child with congenital heart disease
Timepoint
Before the intervention and at the end of the second month
Method of measurement
The quality of life questionnaire of a child with congenital heart disease
Secondary outcomes
empty
Intervention groups
1
Description
First, an 80-minute face-to-face training session based on dimensions affecting quality of life (medication use, nutrition, communication with friends, cognitive problems, familiarity with congenital heart problems, and physical appearance) will be held in the presence of parents and children. The educational materials have been obtained by reviewing the texts and opinions of cardiologists and the cooperation of professors and nursing experts, and will be provided by animator expert in the form of multimedia and understandable form for the child and playable on mobile phones which produced by Softwares such as Perezi, After that educational package that includes short videos which played in in a face-to-face session (5 minutes for each quality of life aspects) using a micro e-learning and combination of videos with motion graphics will be available for patients. It should be noted that the motion graphics are extracted from the YouTube site and will be recorded in the sound recording studio of the School of Health.
Category
N/A
2
Description
Control group: this group will receive routine hospital training in the form of an educational pamphlet that includes explanations of illness, treatment, and nutrition.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Cardiology Clinic of Imam Reza Hospital, Mashhad
Full name of responsible person
Dr.Tahereh Sadeghi
Street address
School of midwifery and nursing, Ibn sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3225 5723
Email
Sadeghit@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Robabeh Latifnezhad
Street address
School of midwifery and nursing, Ibn sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3852 8511
Fax
+98 51 3852 8511
Email
latifnejadr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of midwifery and nursing, Ibn sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3852 8511
Email
Sadeghit@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of midwifery and nursing, Ibn sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3852 8511
Email
Sadeghit@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atousa Dezhraftar
Position
Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 48, Vahid 7 Ave.,Vahid St
City
Mashhad
Province
Razavi Khorasan
Postal code
9155918934
Phone
+98 51 3859 1511
Fax
Email
dezhra2@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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