Comparison of the effect of group and virtual training to mothers on the quality of life of children's with leukemia
Design
Randomized clinical trial without control group, not blinded, uncontrolled with placebo, single-centered.
Settings and conduct
In this study, 68 mothers of children's with leukemia who were hospitalized in the Amirkabir Hospital in Arak were studied.
Participants are randomly divided into first and second intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Mental and physical health
Communication abilities
Not having specific diseases
Not employment as health professionals
Access to virtual space and internet
Reading and writing skills
Exclusion criteria:
Unwillingness to participate in the study
Intervention groups
First intervention group: In the virtual training group, educational content will sent for mothers once a week (for three weeks) using Soroush's messenger as text, photos and videos.
Second intervention group: In the group training group, the samples will placed in 3 groups and for each group, once a week (for three weeks), a 1 to 1.5 hour training session will be held at the hospital congress hall.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190507043511N1
Registration date:2019-08-10, 1398/05/19
Registration timing:registered_while_recruiting
Last update:2019-08-10, 1398/05/19
Update count:0
Registration date
2019-08-10, 1398/05/19
Registrant information
Name
Mojtaba Abdolhoseinpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6595 3927
Email address
hoseinpoormojtaba@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of group and virtual training to mothers on the quality of life of children's with leukemia
Public title
Effect of group and virtual training on quality of life in children's with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mental and physical health
Communication abilities
Not having specific diseases
Not employment as health professionals
Access to virtual space and internet
Reading and writing skills
Exclusion criteria:
Unwillingness to participate in the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples were selected using convenience sampling and then randomly using blocked randomization divided into two first and second intervention groups.
At first, 6 blocks will constructed (ABAB ABBA, BBAA, BABA, BAAB, and AABB). Then, these blocks are arranged using a random number table, and individuals will assigned to two groups (according to "A" and "B" letters).
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 committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.ARAKMU.REC.1398.063
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C95
ICD-10 code description
Leukemia of unspecified cell type
Primary outcomes
1
Description
Quality of life score in children's quality of life questionnaire
Timepoint
Before and one month after educational sessions
Method of measurement
Children's quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the virtual training group, educational content will sent for mothers once a week (for three weeks) using Soroush's messenger as text, photos and videos.
Category
Lifestyle
2
Description
Second intervention group: In the group training group, the samples will placed in 3 groups and for each group, once a week (for three weeks), a 1 to 1.5 hour training session will be held at the hospital congress hall.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Alireza Kamali
Street address
Parastar Sq., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Abdolhosseinpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
hoseinpoormojtaba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Abdolhosseinpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
hoseinpoormojtaba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Abdolhosseinpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
hoseinpoormojtaba@yahoo.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
Not applicable
Informed Consent Form
Yes - There is 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
Part of the information's, such as main outcome and the demographic information, can be shared.
When the data will become available and for how long
36 months later.
To whom data/document is available
Researchers in academic and scientific institutions.