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The effect of web – based education of parents on the level of post-traumatic stress symptom in children

Protocol summary

Study aim
1. Determine and compare the level of symptoms of post traumatic stress in children in both control and test groups before intervention 2. Determination and comparison of the level of symptoms of post traumatic stress in children in both control and post-interventional groups
Design
Clinical trial with control and intervention group, non-blind, non-randomized, Phase does not apply
Settings and conduct
Shahid Rajai Faculty of Medicine, Qazvin University of Medical Sciences, web-based psychological education to Parenting
Participants/Inclusion and exclusion criteria
Inclusion criteria Child: - The age range of the child is 18-18 years - Childbirth due to a traumatic event - The child is admitted for 3 days to one month after the accident - The child has a score higher than 17 according to the CRIES-8 questionnaire - The child is not harmed by abuse of the parent Parents: - Ability to read and write in Persian language - Have a diploma or higher education level - The ability to use the Internet, Web site and electronic gadgets - Not having any known psychological and physical disorder Exit criteria - Child's death during research - GCS loss and changes in the level of consciousness of the child after entering the study - Lack of parental support for further intervention
Intervention groups
Control group: All children with injuries and parents (parents) without intervention Intervention group: All children with injuries and parents (parents) receiving intervention
Main outcome variables
The Effective Effect of E-Learning on Parents' Poverty Stress Symptoms in Children

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180218038777N1
Registration date: 2018-03-05, 1396/12/14
Registration timing: prospective

Last update: 2018-03-05, 1396/12/14
Update count: 0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Zakieh Omidvar Eshkalak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 6875
Email address
omidvar@edu.ikiu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of web – based education of parents on the level of post-traumatic stress symptom in children
Public title
Effect of web – based education of parents on the level of post-traumatic stress symptom in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Child: The age range of the child is between 10 - 18 years of age, Child:the child is admitted to a traumatic event, including falling, car and motor crashes, limb fracture, multiple injuries, limb injuries, veins, visceral injury, burns, mild head injuries (GCS <14) Child:The child's admission period is 3 days to one month after the accident Child:the child has a score higher than 17 according to the CRIES-8 questionnaire Child:ased on the documentation of the child's injury case due to abuse of the parent. Parents:ability to read and write in Persian Parents:having a higher education level and higher Parents: the ability to use the Internet, website and electronic devices Parents: not having any known psychological and physical impairment
Exclusion criteria:
Childbirth during the study GCS loss and changes in the level of consciousness of the child after entering the study the lack of parental cooperation to participate in the intervention
Age
From 10 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran Nursing and Midwifery Faculty, Rashid Yasemi Ave, Vanek
City
Tehran
Province
Tehran
Postal code
3471783381
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
IR.IUMS.FMD.REC1396.9211196239

Health conditions studied

1

Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
The level of stress in the CRIES-8 questionnaire
Timepoint
At the beginning of the study and 6 weeks after the intervention
Method of measurement
CRIES-8 questionnaire

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: A psychological training and child and parental stress control program for four weeks online from a web site made by a researcher at www. PTSD- pediatric nursing-care.ir
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
zakieh omidvar
Street address
Shahid Rajaee Hospital, padegan street
City
Qazvin
Province
Qazvin
Postal code
3471783381
Phone
+98 28 3333 5800
Email
zakie.omidvar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zakieh Omidvar
Street address
Rashid Yasemi Street, Vanak
City
Tehran
Province
Tehran
Postal code
3471783381
Phone
+98 21 4365 1000
Email
zakie.omidvar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zakieh Omidvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaee Hospital, Padehgan Street
City
Qazvin
Province
Qazvin
Postal code
3471783381
Phone
+98 28 3379 6875
Email
zakie.omidvar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zakie Omidvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaee Hospital, Padehgan Street
City
Qazvin
Province
Qazvin
Postal code
3471783381
Phone
+98 28 3379 6875
Email
zakie.omidvar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zakie Omidvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaee Hospital, Padehgan Street
City
Qazvin
Province
Qazvin
Postal code
3471783381
Phone
+98 28 3379 6875
Email
zakie.omidvar@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Unidentifiable data subjects are shared
When the data will become available and for how long
Start access after printing data
To whom data/document is available
All people
Under which criteria data/document could be used
Certain conditions are not considered
From where data/document is obtainable
site www. ptsd-pediatric-nursing-care.ir
What processes are involved for a request to access data/document
After requesting a link to the administrator on the site, the data is sent to the person's email
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