Development and evaluation of the effectiveness of gamification in self-care among children with celiac disease.
In this study, a game is designed to help children and adolescents with celiac disease learn necessary care for the disease.
Design
This is a non-randomized, double-blind, parallel-group clinical trial that will be conducted on a total of 120 children with celiac disease in two groups of control and intervention.
Settings and conduct
This study aims to assist in learning celiac self-care and will be conducted in medical centers affiliated to Urmia University of Medical Sciences in Urmia city. A program is designed to educate children about necessary care for their disease through gaming, the effectiveness of which will be measured by its impact on the knowledge, performance, and attitudes of children and their families in the intervention group compared to the control group. Quantitative variables such as height, weight, and laboratory tests will be also measured. The final statistical analysis will be performed by a qualified statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with celiac disease in the 7-15 age group
Children who have been diagnosed with celiac disease for at least six months
Having a smartphone in the family
Exclusion criteria:
Children with celiac disease and type 1 diabetes in the 7-15 age group
Children with celiac disease and Down syndrome in the 7-15 age group
Children with celiac disease and thyroid dysfunction in the 7-15 age group
Intervention groups
The intervention group will use gamification, while the control group follows traditional methods.
Main outcome variables
Qualitative variables:
Function
Knowledge
attitude
Quantitative variables:
Weight
height
Anti TTG(IgA ) & Anti TTG(IgG )
Abdominal pain frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058509N1
Registration date:2023-10-13, 1402/07/21
Registration timing:prospective
Last update:2023-10-13, 1402/07/21
Update count:0
Registration date
2023-10-13, 1402/07/21
Registrant information
Name
sahar hadifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 635 4491
Email address
hamanhadifar1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation of the effectiveness of gamification in self-care among children with celiac disease.
Public title
The effect of games on the self-care among children with celiac disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with celiac disease in the 7-15 age group
Having a smartphone
Children who have been diagnosed with celiac disease for at least six months
Exclusion criteria:
Children with celiac disease and thyroid dysfunction in the 7-15 age group
Children with celiac disease and Down syndrome in the 7-15 age group
Children with celiac disease and type 1 diabetes in the 7-15 age group
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is being developed and the executive researchers have decided to largely blind the participants after designing the intervention based on its capabilities. For statistical analysis, it was decided that the results of the study, which are collected in the form of a questionnaire, will be encrypted and only raw data will be available to the analyst. Moreover, the raw encrypted data (both qualitative and quantitative) will be classified and made available to the analyst in a two-group (A and B) form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.UMSU.REC.1402.178
2
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.UMSU.REC.1402.178
Health conditions studied
1
Description of health condition studied
Celiac disease
ICD-10 code
K90.0
ICD-10 code description
Celiac disease
Primary outcomes
1
Description
Anti TTG(IgA ) & Anti TTG(IgG)level
Timepoint
Before and after the intervention
Method of measurement
laboratory test
2
Description
Performance
Timepoint
Before and after the intervention
Method of measurement
KAP study questionnaire
3
Description
Knowledge
Timepoint
Before and after the intervention
Method of measurement
KAP study questionnaire
4
Description
attitude
Timepoint
Before and after the intervention
Method of measurement
KAP study questionnaire
5
Description
Weight
Timepoint
Before and after the intervention
Method of measurement
Weight measurement
6
Description
Height
Timepoint
Before and after the intervention
Method of measurement
Height measurement
7
Description
Abdominal pain frequency
Timepoint
Before and after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 children with celiac disease who were randomly assigned to the intervention group and used a mobile-based program designed to help them learn self-care skills for six months. First, the quantitative and qualitative variables are measured in the intervention group before the intervention. Then, the same variables will be re-measured after the end of the intervention and the effectiveness of the program will be determined by comparing the results before and after the intervention.
Category
Behavior
2
Description
Control group: 30 children with celiac disease who were randomly assigned to the control group and used a routine and traditional educational program to learn self-care skills for six months. First, the quantitative and qualitative variables are measured in the control group before the intervention. Then, the same variables will be re-measured after the end of the intervention and the effectiveness of the program will be discussed by comparing the results before and after the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences
Full name of responsible person
Sahar Hadifar
Street address
Orjhans Street, Resalat Blvd, Urmia ,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 44 3223 4897
Email
paramed@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Hadifar
Position
Master of health information technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Allied Medical Sciences, Serou Road, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 1930
Email
hamanhadifar1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Hadifar
Position
Master of health information technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Allied Medical Sciences, Serou Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 1930
Email
hamanhadifar1995@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Hadifar
Position
Master of health information technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Allied Medical Sciences, Serou Road, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 903 635 4491
Fax
Email
hamanhadifar1995@gmail.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
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