Protocol summary

Study aim
Determining the Effect of Care Education of Mothers of Children with Cerebral Palsy on their maternal Depression and Anxiety
Design
This is a quasi-experimental study that is conducted with researcher intervention and care education of mothers of children with cerebral palsy. The study population consisted of all referred mothers as inpatient and outpatient with a cerebral palsy child, under the age 15 years. It is conducted at Bahonar hospital in Karaj. The sampling method was based on the objective sampling method and divided into two groups as randomly selected and each participant is assigned a code.
Settings and conduct
This study was conducted with a demographic inventory to collect data. That includes some questions such age, level of education and economic status of the mothers. To collect data on the status of caring for a child with cerebral palsy a six-part checklist was used that provides information about; 1- the mode of transportation of the body; 2- the correct positioning; 3- dressing and dressing up; 4- feeding; 5- going to bed; and 6- bathing. That was leveled in good, moderate or poor by answers as yes, to some extent or no. They will be given a Beck anxiety and depressing inventory to answer.The location of the study is Bahonar hospital,Karaj
Participants/Inclusion and exclusion criteria
The mother with a child with cerebral palsy under the age of 15 ; The mother is literate ; The child has no other chronic illness ;The father of the family is not addicted or unemployed; There is no record of divorce in the family; The primary responsibility for caring for the child with cerebral palsy lies with the mother; The mother cares for only one disabled child Only one child cerebral palsy in the family; There is no history of caring for a child with cerebral palsy; Non of the main members of the family of medical personnel The mother is not in a mental state for mental healt
Intervention groups
The intervention group consisted of 30 mothers of children with cerebral palsy, cerebral palsy caregiver training them for classes in six half-hour sessions over 2 weeks are.The training program will be implemented by lecture method in 6 half-hour sessions for 2 weeks and will be implemented by using teaching aids such as Pamphlet and Slid Training at the appropriate place in the hospital in the form of group training (in groups of up to 5 people). The training will be provided theoretically and practically by means of a puddle. After that, the checklist for the health and care of children with cerebral palsy is filled with observation by the researcher and the mothers' skills in helping the child to carry out daily life activities in the six areas mentioned one week after training, Beck Anxiety Inventory (BAI) and Beck Depression Inventory will be provided to the units under study. In case of discharge, the child will be completed by the mothers by returning to the home.In the control group, which consisted of 30 mothers of children with cerebral palsy is only routine training program receive.
Main outcome variables
In this research, caring for children with cerebral palsy to independent mothers will be independent and the level of anxiety and depression in dependent mothers with variable cerebral palsy is dependent.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170725035308N2
Registration date: 2018-02-07, 1396/11/18
Registration timing: retrospective

Last update: 2018-02-07, 1396/11/18
Update count: 0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Laila Panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6666
Email address
falaee@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Tehran Medical Branch
Expected recruitment start date
2017-11-03, 1396/08/12
Expected recruitment end date
2017-12-03, 1396/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Pediatric care education for children with cerebral palsy on anxiety and depression in mothers
Public title
The Effect of Care Education on Anxiety and Depression in Mothers of Children with Cerebral palsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mother with a child with cerebral palsy under the age of 15 The mother is literate The child has no other chronic illness The father of the family is not addicted or unemployed There is no record of divorce in the family The primary responsibility for caring for the child with cerebral palsy lies with the mother The mother cares for only one disabled child Only one child cerebral palsy in the family There is no history of caring for a child with cerebral palsy. Non of the main members of the family of medical personnel The mother is not in a mental state for mental health
Exclusion criteria:
Do research in one center only
Age
From 1 month old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
The Ethics Committee of Islamic Azad University, Tehran Medical Branch. Tehran, Iran. Islamic Azad U
Street address
Zargande avn, Shariati avn
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IAU.TMU.REC.1396.92

Health conditions studied

1

Description of health condition studied
anexity
ICD-10 code
F50-F59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors

2

Description of health condition studied
Depresion
ICD-10 code
F50-F59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors

3

Description of health condition studied
Cerebral Palsy
ICD-10 code
G80-G83
ICD-10 code description
Cerebral palsy and other paralytic syndromes

Primary outcomes

1

Description
Depression and anxiety
Timepoint
Before the intervention, one month after the intervention
Method of measurement
پرسشنامه افسردگي و اضطراب بك. چك ليست

Secondary outcomes

empty

Intervention groups

1

Description
Group intervention in this group of mothers of children with cerebral palsy care education for classes in six half-hour sessions will be conducted within 2 weeks.
Category
Lifestyle

2

Description
En Control group: in this group just routine teaching were received
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Leila Panahi
Street address
Shora Blvd
City
Karaj
Province
Alborz
Postal code
3154985318
Phone
+98 26 3254 8395
Email
Panahi.leila56@gmail.com
Web page address
http://WWW.iautmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Hejazi
Street address
Zargande Avn, Shariati Avn
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6666
Email
hejazi.shirin@yahoo.com
Web page address
http://WWW.iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Fateme alaee karahroudy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zargandeh Avn, Shariati Avn
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6666
Fax
Email
Falaee@iautmu.ac.ir
Web page address
http://WWW.iautmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Alaee Karahroudy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zargandeh Avn, Shariati Avn
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6666
Fax
Email
Falaee@iautmu.ac.ir
Web page address
http://WWW.iautmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Alaee Karahroudy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zargandeh Avn, Shariati Avn
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6666
Fax
+98 21 2200 6666
Email
Falaee@iautmu.ac.ir
Web page address
http://WWW.iautmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
this reaserch is not completed
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
Loading...