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The effect of motor games on the development motor skills and depression in hospitalized children

Protocol summary

Study aim
The effect of play on depression and motor development of sick children
Design
The clinical trial has two intervention and control groups. Based on the scope of the research, 30 children aged 3 to 6 years, girls and boys with leukemia, lymphoma, sarcoma, etc. admitted to the oncology ward were purposefully selected and randomly divided into two Intervention and control groups are included.The research design is quasi-experimental with pre-test and post-test.
Settings and conduct
children who have a case of hospitalization in Afzalipour Hospital, Kerman and have the conditions to enter the study will be selected and randomly divided into experimental and control groups. Both groups will take pre-tests, including the Broninex Ozertsky test and the CDS Depression. Then intervention group will be affected by the motor games for 8 weeks (2 or 3 sessions a week, 60 minutes). At the end of the intervention sessions, post-test (Ozertsky test and CDS Depression Scale) will be taken from both groups
Participants/Inclusion and exclusion criteria
Entry requirements: Based on medical records normal IQ, The duration of hospitalization is more than a few weeks.Age range is 3 to 6 years No entry conditions: They will not be able to attend play therapy sessions, Have a medical ban on sports and games, parental dissatisfaction
Intervention groups
Intervention group: pre-test will be taken. After the pre-test, the group will be affected by the motor games for 8 weeks (2 sessions per week, 60 minutes).At the end of the intervention sessions, a post-test will be taken. Control group: pre-test will be taken. After the pre-test, no intervention is performed, and after 8 weeks, the post-test, will be taken.
Main outcome variables
Communication with the child; Trust in the child Accept instructions in the child; Fear in the child; Child motor development

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210318050739N1
Registration date: 2021-04-23, 1400/02/03
Registration timing: registered_while_recruiting

Last update: 2021-04-23, 1400/02/03
Update count: 0
Registration date
2021-04-23, 1400/02/03
Registrant information
Name
Hamide Moeini nejad
Name of organization / entity
The university of Semnan
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 5631
Email address
h-moeine@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motor games on the development motor skills and depression in hospitalized children
Public title
The effect of motor games on the development of fundamental motor skills and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Evidence of cancer Age range 3-6 year Based on a medical record with normal IQ Same level of motor skills Homogeneous in terms of height and weight
Exclusion criteria:
Children who have been hospitalized for less than a week They are not allowed to participate in play therapy sessions They have a medical ban on sports and games
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Sample purposefully selected, And as a simple random selection, Due to the homogeneity of the samples, the lottery method is used. People's names are written on paper and put inside the box. Than the papers are taken out one by one, Until the desired sample, which is about 30 people, is completed.
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 commitee of Semnan Uiversity of Medical Scinces
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.SEMUMS.REC.1399.347

Health conditions studied

1

Description of health condition studied
Children with various types of cancer(Leukemia, Lymphoma, Sarcoma, etc
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score a person gets on the Bruininks- Oseretsky test
Timepoint
Perform pre-test Bruininks- Oseretsky) Before starting the intervention and post-test depending on the length of hospitalization of children About three months after the pre-test
Method of measurement
Test Bruininks-Oseretsky , purposeful motor games from the game book for the all round development of the child Brian Barrett

2

Description
Depression score in the Depression Assesment Questionnaire Cds (Fisher Child Depression Scale)
Timepoint
Perform pre-test(Fisher and Lang) Before starting the intervention and post-test depending on the length of hospitalization of children About three months after the pre-test
Method of measurement
Fisher and Lang Children's Depression Test; purposeful motor games from the game book for the all round development of the child Brian Barrett

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: َ After pre-testing (Bruininks Oseretsky & Child Depression scale) the intervention group for 8 weeks, tow or three sessions a week, 60 minutes Are affected by the intervention( motor games) from the book, Games for the whole child, Brian Barrett. the after the intervention (motor games) so the test will be taken(Bruininks Oseretsky & child Depression scale, Fisher and Lang)
Category
Rehabilitation

2

Description
Control group: pre-testing (Bruininks-Oseretsky & Child Depression Scale) is taken. The control group does not undergo any intervention and at the end of the post-test will be taken (Bruininks- Oseretsky & Child Depression Scale)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Mohammed Hussain Mehr Al Hasane
Street address
Near Bahonar University, Imam Khomeini Hwy
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
Email
paafzali@kmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Semnan
Full name of responsible person
Seifollah Sadodin
Street address
Campus No,1 , In front of Sokan Park
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4138
Fax
+98 23 3365 4136
Email
s_sadodin@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Semnan
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
The University of Semnan
Full name of responsible person
Hamide Moeini Nejad
Position
Student
Latest degree
Master
Other areas of specialty/work
Motor Behavior- Motor Development
Street address
No.37, 36 Goldast Av, Goldast st, Kerman
City
Kerman
Province
Kerman
Postal code
7617634978
Phone
+98 34 3321 5368
Email
Moeinihm4084@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Hamide Moeini nejad
Position
Student
Latest degree
Master
Other areas of specialty/work
Motor Behavior-Motor Development
Street address
No.37,Goldasht36, Goldasht st, Kerman
City
Kerman
Province
Kerman
Postal code
7617634978
Phone
+98 34 3321 5368
Fax
Email
Moeinihm4084@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Hamide Moeini Nejad
Position
Student
Latest degree
Master
Other areas of specialty/work
Motor Behavior-Motor Development
Street address
No.37,Goldasht36, Goldasht st, kerman
City
Kerman
Province
Kerman
Postal code
7617634978
Phone
+98 34 3321 5368
Fax
Email
Moeinihm4084@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifying individuals
When the data will become available and for how long
From the year 2021
To whom data/document is available
All applicants are allowed to access the data
Under which criteria data/document could be used
According to the terms and conditions of Semnan University, the data can be used
From where data/document is obtainable
Refer to semnan University. postal code: 3531-19111, Phone: 00982331530000, Fax: 00982333321005
What processes are involved for a request to access data/document
From the beginning of November, 2021, After defending the dissertation
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