This study will be done with aim to survey the effect of a designed computer game on the quality of life of children undergoing chemotherapy in Imam Reza hospital of Isfahan in 2015. This is non-blinded clinical trial.
The study population will be included all children with cancer undergoing chemotherapy that refer to Seyed Al Shohada hospitals in Isfahan and a total of 64 eligible patients will be selected and randomly will divided into two experimental and control groups. Before intervention the quality of life questionnaire will be provided for children with cancer or their parents in both groups. Then the computer game will be trained and computer game will be provided for the children. They will be asked to do the game with focus and precision for at least 3 hours a week for four consecutive weeks. To ensure the authenticity of doing the game, researchers will call parents by available phone number and they will be asked about the time and duration of a child's play. The control group will not receive special intervention and routine process will be carried out. Then, immediately and one month after the last week of doing the game, the quality of life questionnaire will be provided for both groups again and the two groups will be compared.
Inclusion criteria: Age between 8 to 12 years; Undergoing chemotherapy for at least 4 months; The ability to perform computer game
Exclusion criteria: A stressful event such as parental divorce, parental death; Change Location
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102414333N60
Registration date:2016-11-20, 1395/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-20, 1395/08/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of a designed computer game on the quality of life of children undergoing chemotherapy
Public title
Effect of a designed computer game on quality of life of children undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 8 to 12 years; Catching a type of cancer; Undergoing chemotherapy for at least 4 months; The ability to perform computer game; Ability to understand and read Persian dialects; No major physical or psychological problem.
Exclusion criteria: A stressful event such as parental divorce, parental death, brother or sister death; Change Location during study that affected quality of life, self-esteem and the creation of stress
Age
From 8 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Committee Ethics, Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
Ir.mui.rec.1393.3.511
Health conditions studied
1
Description of health condition studied
leukaemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukaemia
Primary outcomes
1
Description
Quality of life
Timepoint
The beginning of the study, after study and one month after the end of the study
Method of measurement
According to Children with Cancer Quality of Life Questionnaire (PedsQL Cancer module version 3.0)
Secondary outcomes
empty
Intervention groups
1
Description
The control group will not receive special intervention
Category
Other
2
Description
The intervention group will do the computer game with focus and precision at least 3 hours a week for four consecutive weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Hospital
Full name of responsible person
Seyedeh Zahra Fazelnia
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Talakoub
Position
Master of Pediatric and Neonatal Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3226 5904
Fax
Email
talakoub@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Fazelnia
Position
Master of nursing children
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3226 5904
Fax
Email
zahrafazeliz@yahoo
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)