Determining the effect of education based on the theory of planned behavior on the resilience of mothers with children with cerebral palsy
Design
A randomized clinical trial with a control group, which will be conducted on 60 mothers of children with cerebral palsy. No blinding due to being educational.
Allocating people to two intervention and control groups will be done using blocks.
Settings and conduct
The place of study will be the exceptional schools of Qom.
After visiting the schools, the purpose of the study will be explained to the individuals, then the control and intervention groups will be completed by assigning code A or B to the individuals.
Participants/Inclusion and exclusion criteria
Having a child with cerebral palsy, no history of participating in educational or counseling classes, not suffering from known chronic diseases, having literacy, willingness to participate in the study.
Absence of more than two sessions, unwillingness to cooperate
Intervention groups
For the intervention group, 4 training sessions of 45 to 60 minutes will be held (once a week).
After the completion of the intervention and obtaining the results, the educational content will also be available to the control group.
Main outcome variables
Improvement of resilience is expected in the intervention group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N67
Registration date:2023-10-17, 1402/07/25
Registration timing:prospective
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on the theory of planned behavior on the resilience of mothers of children with cerebral palsy
Public title
The effect of resilience on mothers of children with cerebral palsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with cerebral palsy in elementary or guidance school (according to the examination of medical documents)
Lack of history of participating in educational or counseling classes in the field of improving self-esteem or adapting to the environment
Not suffering from known chronic diseases such as psychiatric disorders and problems
Literacy for reading and writing
Willingness to participate in the study
Exclusion criteria:
َََََََََََََََََََََََAbsence of more than two sessions in training classes
Unwillingness to Cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating people to two intervention and control groups will be done using blocks (AABB, ABAB, ABBA, BBAA, BABA, BAAB).
The randomization unit will be individual.
The randomization tool for choosing the block unit will be dice.
Due to the present study is an educational type, there will be no possibility of blinding.
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 Nursing and Midwifery Faculty and Rehabilitation Faculty of Tehran University of
Street address
School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-08-16, 1402/05/25
Ethics committee reference number
IR.TUMS.FNM.REC.1402.116
Health conditions studied
1
Description of health condition studied
Resilience of mothers of children with cerebral palsy
ICD-10 code
F62.0
ICD-10 code description
Enduring personality change after catastrophic experience
Primary outcomes
1
Description
Score of resilience
Timepoint
Before the intervention, immediately, four and eight weeks after the intervention
Method of measurement
The Connor-Davidson Resilience Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will have an intervention group that will receive educational materials based on the theory of planned behavior during 4 weekly sessions of 45 to 60 minutes The educational components include the history of cerebral palsy and its global statistics, the importance of the type of communication with these children, the definition of resilience, the results of improving resilience and aspects of improving the quality of life, the importance of improving the quality of life of these mothers, the importance of obtaining education and correct information regarding Improving resilience, positive and negative attitudes towards having a child with cerebral palsy, mental beliefs, knowledge and attitude of a person about having a sick child and...
Category
Behavior
2
Description
Control group: In the control group, which includes mothers of children with cerebral palsy and have the inclusion criteria, no intervention was performed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Exceptional schools of Qom city
Full name of responsible person
Zahra Behboodi Moghadam
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
Higher_education@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
No23, Valiasr Avenue, Dameshgh Street, Vice chancellor for research, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3619
Email
gojelou@farabi.tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
zahrabehboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
behboodi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Zahar_behboodi@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' information is protected and their names are not required.
When the data will become available and for how long
1403
To whom data/document is available
Reputable journals
Under which criteria data/document could be used
Universities of Medical Sciences
From where data/document is obtainable
Try not to use the documents personally
What processes are involved for a request to access data/document