Protocol summary

Study aim
Designing and evaluating a serious educational game to improve controlling emotional skills of members at Center of Children and Adolescents Intellectual Development of Mashhad
Design
Participants: Age group 7 to 9 years Assessment tool: Questionnaire in the book entitled “Rabbit Feelings” Randomization: the children will be divided into intervention and control groups using the envelope method. Random numbers will be prepared and printed from www.randomaize.com and then placed in an envelope in a way that contents won’t be identifiable. Phase 1: All participants will be pre-tested through a questionnaire. Phase 2: Children in the intervention group, in addition to receiving routine training, will interact with a serious educational game (with the aim of training emotional skills including anger, sadness, fear, and happiness). Phase 3: All participants will be evaluated through the post-test. Sample size: 27
Settings and conduct
Setting: Center of Children and Adolescents Intellectual Development of Mashhad
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Membership in Center of Children and Adolescents Intellectual Development of Mashhad 2- Parental consent Exclusion criteria: Dealing with mental disorders
Intervention groups
Intervention group: In this group, in addition to routine training (face-to-face training), they would also be trained through the developed game. Control group: Children in this group will receive routine training which is face-to-face training.
Main outcome variables
anger control skill; sadness control skill; fear control skill; happiness control skill

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170924036366N2
Registration date: 2021-02-04, 1399/11/16
Registration timing: registered_while_recruiting

Last update: 2021-02-04, 1399/11/16
Update count: 0
Registration date
2021-02-04, 1399/11/16
Registrant information
Name
Nahid Sharifzadeh
Name of organization / entity
Faculty of Medicine of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8299
Email address
sharifzadehn941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating a serious educational game to improve controlling emotional skills of members at Center of Children and Adolescents Intellectual Development of Mashhad
Public title
Design and evaluation of an educational Serious Game to control emotional skills
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Membership in Center of Children and Adolescents Intellectual Development of Mashhad Parental consent
Exclusion criteria:
Dealing with mental disorders
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be used. A numeric code will be assigned to each case. Then these numbers will be attached to randomization.com and after conducting randomization process and assigning numbers into two groups, cases will be randomly assigned to groups including intervention group and control 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
Deputy of Research of Mashhad University of Medical Sciences
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
8771685873
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.417

Health conditions studied

1

Description of health condition studied
Emotional skills
ICD-10 code
z73
ICD-10 code description
Problems related to life management difficulty

Primary outcomes

1

Description
Emotional skills (including fear, anger, happiness, sadness)
Timepoint
Before the intervention and two months after the end of the intervention
Method of measurement
emotional skills questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Electronic learning intervention will be done through a serious game. In addition to the routine training, a serious game will be used for training. The game will be developed in a single user environment for android OS to be installed on a tablet in order to help the trainer to do the intervention easily. The game will be design based on the book entitled "Rabbit Feelings" by Trace Moroney. This book is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9. The child would consider himself/herself as a third person in the game and the training would be done entirely interactive so that a suitable feedback would be given to him/her for every action. The most important advantages of using this approach to train children are being interactive, repetitive and giving feedback. Intervention period will be one month.
Category
Other

2

Description
Control group: The children in the control group will just receive routine training based on the book entitled "Rabbit Feelings" by Trace Moroney which is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9.. In this approach, the trainer once read the book for the children and try to explain them all mentioned emotions and how to control those emotions orally.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of Children and Adolescents Intellectual Development of Mashhad
Full name of responsible person
Seyyed Mohammad Tabatabaei
Street address
Palestine Street No. 26
City
Mashhad
Province
Razavi Khorasan
Postal code
9178113456
Phone
+98 51 3761 6076
Email
sharifzadehn9@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Maliheh Dadgarmoghaddam
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3882 7049
Email
sharifzadehn9@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research of 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
Faculty of Medicine of Mashhad
Full name of responsible person
Nahid Sharifzadeh
Position
Master in Medical Informatics
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics - Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3882 7049
Email
nd.sharifzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medicine of Mashhad
Full name of responsible person
Seyyed Mohammad Tabatabaei
Position
Assistant Professor of Medical Informatics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3882 7049
Email
tabatabaeimh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Medicine of Mashhad
Full name of responsible person
Nahid Sharifzadeh
Position
Master in Medical Informatics
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3882 7049
Email
nd.sharifzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will all be anonymous and encrypted. So, all the data will be shared.
When the data will become available and for how long
Once the results are published indefinitely, unlimited access will be possible.
To whom data/document is available
There is no limitation.
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
We pledge to respond by tabatabaeimh@mums.ac.ir
What processes are involved for a request to access data/document
We pledge to respond within one business day by tabatabaeimh@mums.ac.ir
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