Protocol summary

Study aim
Determining the effect of using a self-care application on the lifestyle and quality of life of children with leukemia undergoing chemotherapy
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized and on 60 patients, the lottery method will be used for randomization.
Settings and conduct
After designing the software in the Android environment by the software engineering team, first, the lifestyle and quality of life questionnaire of cancer children will be completed and collected by both groups, which are children with leukemia undergoing chemotherapy at Dr. Sheikh Mashhad Hospital. The intervention group will be trained through the application by the researcher and the control group will receive the same educational content in the form of pamphlets and face-to-face training. After completing the questionnaires, 2 months from the end of the intervention, data analysis will be done. It is not possible to blind the research units due to installing the software and blinding the data collectors due to all the procedures being performed by the student.
Participants/Inclusion and exclusion criteria
The population of this research is children with acute leukemia. Inclusion: age range of 7-12 years, suffering from acute leukemia, history of chemotherapy for more than one month, access to a smart mobile phone and the ability to use it. Exclusion: using educational games related to the disease, suffering from a psychological disease
Intervention groups
The intervention group will be trained through the application by the researcher, and in the control group, the same educational content will be presented in the form of pamphlets and face-to-face training. The educational content of the application will be related to self-care of children with leukemia with video, text, audio and image content.
Main outcome variables
Lifestyle, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211007052692N2
Registration date: 2022-12-17, 1401/09/26
Registration timing: prospective

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Fatemeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 5764
Email address
karimif992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using self-care application on the lifestyle and Quality of life of children with leukemia undergoing chemotherapy
Public title
Using a self-care application in children with leukemia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 7 to 12 years Having acute lymphoblastic and myeloblastic leukemia A history of chemotherapy for more than one month Access to a smart mobile phone with Android operating system and the ability to use it
Exclusion criteria:
Using educational games related to the disease Having a psychological illness
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples is done in such a way that patients are entered into two groups of 30 people, intervention or control based on the balanced block method. Considering that completing the research tools and installing the application with relevant explanations will be done when the child is discharged from the ward and in a separate room, so the possibility of information leakage will be very minor or will not exist at all. Random allocation is also done in such a way that at first 6 blocks of 4 will be formed from different placement situations of the two groups and then a lottery will be done once to select the order of the blocks. the advantage of this method is that for every 4 blocks of the research unit, half of the people in the intervention group and half of them will be the 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
Mashhad University of Medical Science
Street address
In front of University 18, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.050

Health conditions studied

1

Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia

2

Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia

Primary outcomes

1

Description
life style
Timepoint
Before and 2 months after the intervention
Method of measurement
Lifestyle questionnaire of children with leukemia

2

Description
Quality of Life
Timepoint
Before and 2 months after the intervention
Method of measurement
Quality of life questionnaire for children with cancer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After justification by the researcher and parents, this group will undergo self-care training using the application method. The designed application has educational items about self-care in children with leukemia in the use of diet and medicine, activity and rest and with video, text, audio and image, which will be available to the child in the specified time period.
Category
Lifestyle

2

Description
Control group: This group receives the same educational content related to self-care in children with leukemia undergoing chemotherapy in the form of pamphlets and face-to-face training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Sheikh Mashhad Hospital
Full name of responsible person
Ali Ghasemi
Street address
Dr. Sheikh Children's Hospital, Dr. Sheikh Street, Tawheed Square
City
Mashhad
Province
Razavi Khorasan
Postal code
917351358
Phone
+98 51 1726 9021
Email
ghasemial@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Research and Technology Vice-Chancellor, Qurashi Building, Next to Hoizeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2288
Email
ghayourem@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimif992@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Behnam Vashani
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
behnamhr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimif992@mums.ac.ir

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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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