The effect of Group education on adaptive behaviors and caregiver burden in mothers of children with thalassemia major
Design
Clinical trial with intervention and control group, Not blind, randomized,
Settings and conduct
The researcher will refer to the Zahedan Clinic of Ali Asghar (AS) by presenting a letter from the Vice-Chancellor for Research. The research will explain the research objectives for the samples that will meet the criteria for entering the study. Those willing to participate in the study would be divided into two groups of control and Intervention which will be determined randomly. Adaptive behavior and caregiver burden before and after intervention are measured and analyzed by questionnaires. According to the results of the pretest, ineffective adaptive behaviors will be identified and the educational program will be prepared and compiled. One month after the implementation; the rehabilitation questionnaire will be completed by two control and intervention groups. Results will be analyzed in spss software version 21 .
Participants/Inclusion and exclusion criteria
1-Six months past after diagnosis of thalassemia major in children
2. Having reading and writing literacy
3. No responsibility of caring for another patient in the family
4. Living with spouse
5. No known psychiatric disorders and no use of psychiatric drugs
6. Residency in Zahedan
7. Lack of participation in similar studies
8.No hospitalization history in recent months
Intervention groups
Group training will be held in the intervention group in four sessions of two hours (weekly one session).
In the control group, after the end of the intervention, a training session will be held. After training, a booklet will be delivered to them.
Main outcome variables
Adaptive behaviors, caregiver burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170926036426N5
Registration date:2019-04-22, 1398/02/02
Registration timing:retrospective
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
fatihe kermansaravi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 1415
Email address
kermansaravi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Group education on adaptive behaviors and caregiver burden in mothers of children with thalassemia major
Public title
The effect of Group education on adaptive behaviors and caregiver burden
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Six months past after diagnosis of thalassemia major in children
Having reading and writing literacy
Living with spouse
Residency in Zahedan
Exclusion criteria:
Having responsibility to care another patient in the family
Having known psychiatric disorders taking psychiatric drugs
Participation in similar researches
Hospitalization of the patient in recent two months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
They assigned in two groups (intervention and control ) according lottery using numbered card.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Campus Office Complex, Zahedan University of Medical Sciences and Health Services,Khalig Phars Blvd,Doctor Hesabi square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.195
Health conditions studied
1
Description of health condition studied
thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
adaptive behaviors
Timepoint
Before the intervention - one month after the intervention
Method of measurement
Coping Health Inventory for Parent
Secondary outcomes
1
Description
caregiver burden
Timepoint
Before the intervention - one month after the intervention
Method of measurement
Caregiver Burden Scale
Intervention groups
1
Description
Group Education will perform in four-2hour sessions ( a session weekly). The contents of Educational sessions consists of full explanation of thalassemia disease , group discussion about mothers' experiences of thalassemia disease care through problem solving , stress management, and the method for confronting disease.
Category
Behavior
2
Description
Control group: After the end of the intervention, a training session will be held, and the educational pamphlets will be available to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Abdolvahed Shahnavazi
Street address
Azadi Street., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813643353
Phone
+98 54 3322 9688
Fax
Email
b_aliasgharz@yahoo.com
Web page address
Http://www.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Campus Administration Complex, Zahedan University of Medical Sciences and Health Services,.-Persian Gulf Blvd-Dr. Hassabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Abdolhagh Biabani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty,Mashahir Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
hagh909@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kermansaravi
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Zahedan Nursing and Midwifery Faculty,Mashahir Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
f_kermansaravi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolhagh Biabani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty,Mashahir
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
Email
hagh909@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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about people other than your first and last name
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions and
People in the industry are also busy
Under which criteria data/document could be used
For use in scientific papers
From where data/document is obtainable
Use email
What processes are involved for a request to access data/document