The impact of education on anxiety and social adjustment of parents of children with Corona
Design
The clinical trial with the control group will be a simple double-blind randomization
Settings and conduct
Hazrat Ali Asghar Hospital
Participants/Inclusion and exclusion criteria
Entry requirements
Children aged 4 to 18 years
Knowledge of the type of child disease
No stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes
Phone access
No entry conditions
Lack of access to the phone
Intervention groups
In the training intervention group, 4 sessions per week, one 45-minute session will be done by phone and online. Items such as how the disease occurs, the factors that cause its symptoms and complications, treatment of the disease, the need for treatment of the disease, lifestyle changes, the need for preventive activities such as masking, use of alcohol spray, quarantine, Avoid touching contaminated surfaces and avoid getting lost with friends and relatives and follow proper nutrition tips. Advise to manage calm and stress caused by corona. Be receptive and listen. Support the child. Provide a suitable environment during quarantine. Ask for help from support centers if needed. Have a flexible but regular daily schedule to teach your child to keep a safe distance. Have family coordination at home
Main outcome variables
Anxiety and social adjustment
General information
Reason for update
Acronym
کرونا
IRCT registration information
IRCT registration number:IRCT20141216020344N7
Registration date:2021-04-29, 1400/02/09
Registration timing:registered_while_recruiting
Last update:2021-04-29, 1400/02/09
Update count:0
Registration date
2021-04-29, 1400/02/09
Registrant information
Name
Hamidreza Khoshnezhad Ebrahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 2189
Email address
khoshnezhad.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-22, 1400/02/02
Expected recruitment end date
2021-08-28, 1400/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of education on anxiety and social adjustment of parents of children with Corona
Public title
The impact of education on anxiety and social adjustment of parents of children with Corona
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes
Phone access
Knowledge of the type of child disease
Lack of care for another patient at home
Exclusion criteria:
Lack of parental cooperation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.IUMS.REC.1400.005
Health conditions studied
1
Description of health condition studied
coronavirus
ICD-10 code
J12.82
ICD-10 code description
Pneumonia due to coronavirus disease
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Beck Anxiety Questionnaire
2
Description
Social adjustment
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Bell Social Adjustment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group, training 4 sessions per week, a 45-minute session will be done by phone and online. Items such as how the disease occurs, the factors that cause its symptoms and complications, treatment of the disease, the need for treatment of the disease, lifestyle changes, the need for preventive activities such as masking, use of alcohol spray, quarantine, Avoiding touching contaminated surfaces and avoiding losing with friends and relatives and following proper nutrition tips, and social support in the emotional dimension means giving the participant ample opportunity to worry tools and actively listen to his / her words and communication. It will be right with his family.
Category
N/A
2
Description
Control group: Control group: In the control group, only routine ward care is performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital in Tehran
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
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
Dr. Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Position
, Professor,
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
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
Data is encrypted in order to make individuals' identifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr. Hamidreza Khoshnezhad Ebrahimi
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.