The effect of family-centered empowerment model on knowledge and careing performance of mothers of children with leukemia
Design
The clinical trial has a control group, with parallel and randomized groups, and a sample size of 62 mothers with children with leukemia.
Settings and conduct
the study population includes mothers of children with cancer who referred to the oncology department of Baqaei2 hospital. the researcher will start sampling by receiving a letter of introduction. Then by random division in to even and odd numbers they are placed in two groups of test and control.The questionnaire will be given to the samples and then the data will be analyzed.in the next step the intervention is done using educational contents.
Participants/Inclusion and exclusion criteria
inclusion criteria: one of the primary caregivers should be with the patient and live with him, children between the ages of 2 and 12, the primary caregiver will be able to answer questions, participate in research and have the necessary cooperation, at least six months have passed since the diagnosis of disease.Exclusion criteria: lake of willingness to cooperate, failure to attend at least one training session, failure to complete questionnaires, acute problems include bleeding, severe infection, and other issues that prevent the patient and his caregiver from cooperating
Intervention groups
In the intervention group, the family-centered empowerment model will be implemented in four steps (perceived threat, self-efficacy enhancement, self-esteem and process evaluation) that will consist of 5 sessions (two sessions per week). The control group received no intervention
Main outcome variables
knowledge and careing performance of mothers of children with leukemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200325046857N1
Registration date:2020-06-08, 1399/03/19
Registration timing:retrospective
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Fateme Boshagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4265 4418
Email address
f.boshagh2016@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on knowledge and careing performance of mothers of children with leukemia
Public title
The effect of family-centered empowerment pattern on blood cancer in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Live with the patient from the primary caregiver and with the patient
The age of the child includes 2 years to 12 years.
The main caregiver of the family has the ability to answer questions and be able to participate in research and collaboration
At least six months have passed since the diagnosis
Exclusion criteria:
Lack of willingness to cooperate
Do not attend at least one training session
Do not complete questionnaires
Acute problems include bleeding, severe infection, and other issues that prevent the patient from working with him or her
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
samples will be arranged numerically and then randomly divided in to even and odd numbers in two groups of test and control.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.AJUMS.REC.1398.312
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
knowledge ,careing performance
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Specific questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The questionnaire is then distributed among the samples and after analyzing the data, the first step (before the intervention) leads to identifying the limitations, needs and weaknesses of caregivers in various fields. Then, in the second step, the intervention will be done using the educational content of the face. Training takes place in 5 sessions of 45 minutes (two sessions per week). At the end of each session, prepared pamphlets will be provided to patients and their families.
Category
Rehabilitation
2
Description
Control group: The control group did not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqa'i Hospital 2
Full name of responsible person
Fateme Boshagh
Street address
Azadegan Ave
City
Ahwaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3222 2818
Email
f.boshagh2016@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
دکترمحمد بدوی
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
f.boshagh2016@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafal sadat Hakim
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan St
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8622
Email
hakim-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
fateme boshagh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
MSc student
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
f.boshagh2016@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme boshagh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
f.boshagh2016@yahoo.com
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