The impact of computer game on the behavioral distress associated with insulin injection in children with diabetes type 1 in Isfahan Endocrine & Metobolism Research Center
Aim: The purpose of this study is to identify the effect of computer game on the level of behavioral distress of insulin injection in children with type 1 diabetes. For this purpose, 30 children [play group (15) and control group (15)] are selected by using available random sampling from 3-13 years old children of diabetes referred to Isfahan Endocrine and Metabolism Research Center. In this study, used to be demographic information and behavioral distress scale of observation Observational Scale of Behavioral Distress - Revised. OSBD-R scale is completed by mother during insulin injection to child at home. Before of intervention, distress behavior is measured in two groups. So the group played a computer game CD about insulin injections for(at least one a week) one week. In the control group (no intervention) and play group, behavioral distress is evaluated in during, immediately after and two weeks after the intervention. Finally, behavioral distress levels in two groups are compared together using inferential statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123011941N1
Registration date:2014-03-26, 1393/01/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-26, 1393/01/06
Registrant information
Name
Fatemeh Ebrahimpour
Name of organization / entity
Islamic Azad University, khorasgan Branch, (Isfahan)
Country
Iran (Islamic Republic of)
Phone
+98 31153540019
Email address
f.ebrahimpour@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Endocrine & Metabolism Research Center
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of computer game on the behavioral distress associated with insulin injection in children with diabetes type 1 in Isfahan Endocrine & Metobolism Research Center
Public title
The impact of computer game on the behavioral distress associated with insulin injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The child and his parents, have volunteered to participate in the study; Child's physical health disorders (such as cerebral palsy and seizure, etc.) are not; Child's mental and cognitive disorders (such as autism, mental retardation, etc.) are not; Children have access to a computer.
Exclusion criteria: During the intervention, the incidence of conditions for children and families, following the intervention program used by them is not possible.
Age
From 3 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjrib Street
City
Isfahan
Postal code
۳۱۳-۸۱۷۴۵
Approval date
2013-08-24, 1392/06/02
Ethics committee reference number
12/4/0.5/162
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Behavioral Distress assossited with insulin injection
Timepoint
before and during intervention, immediately after intervention and two weeks after the intervention
Method of measurement
Observetional Scale of Bhavioral Distress - Revised
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using the computer game CD called "Capable Child" for one week (at least once a week) at home.
Category
Other
2
Description
Control group: non intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Dr.Mostafa Najafi
Street address
Isfahan Endocrine and Metabolism Research Center, Khoram Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Endocrine & Metabolism Research Center.
Full name of responsible person
Dr.Bijan Iraj
Street address
Isfahan Endocrine & Metabolism Research Center
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Endocrine & Metabolism Research Center.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan Branch, (Isfahan)
Full name of responsible person
Fatemeh Ebrahimpour
Position
Student of Master of Nursing
Other areas of specialty/work
Street address
Jey Street, University Blvd, Arqavanieh, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31153540019
Fax
Email
Fa2892@uahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan Branch, (Isfahan)
Full name of responsible person
Fatemeh Ebrahimpour
Position
Student of Master of Nursing
Other areas of specialty/work
Street address
Jey Street, University Blvd, Arqavanieh, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31153540019
Fax
Email
Fa2892@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan Branch, (Isfahan)
Full name of responsible person
Fatemeh Ebrahimpour
Position
Student of Master of Nursing
Other areas of specialty/work
Street address
Jey Street, University Blvd, Arqavanieh, Isfahan, Iran
City
Isfahan
Postal code
Phone
00
Fax
Email
Fa2892@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)