check the effect of dear child on depression and anxiety in hospitalized children between 6 and 12 years
Design
80 selected children are randomly divided into 2 groups of 40 control and intervention
Settings and conduct
in the pediatric ward of Dr. Ganjavian Hospital, children aged 6 to 12 years admitted to the pediatric ward are selected based on inclusion and exclusion criteria.
Then 80 selected children are randomly divided into 2 groups of 40 control and intervention.
A dear child is considered for the intervention group.she is with the child every morning until noon and performs all aggressive procedures and supportive measures .
she also approaches the child using communication techniquse, play therapy, storytelling and painting, and no intervention is performed for the control group.
The collection tools in this study were the Demographic Information Questionnaire, the standard Reynoles & Richmond Children's Revealed Anxiety Scale(RCMAS), the Maria Kwas Children's Depression Inventory (CDI) . which was completed 3 times by the patient or with help. will be (When admitted to the ward ,48 hours after admission, at discharge)
Data will be analyzed using SPSS statistical software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient is hospitalized in the pediatric ward.
The patient is conscious, has mental stability and is between 6 and 12 years old.
Intervention groups
A dear child is considered for the intervention group.she is with the child every morning until noon and performs all aggressive procedures and supportive measures .
she also approaches the child using communication techniquse, play therapy, storytelling and painting, and no intervention is performed for the control group
Main outcome variables
Depression rate, anxiety rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170607034381N6
Registration date:2022-05-02, 1401/02/12
Registration timing:prospective
Last update:2022-05-02, 1401/02/12
Update count:0
Registration date
2022-05-02, 1401/02/12
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-24, 1401/03/03
Expected recruitment end date
2022-07-25, 1401/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dear child presence on anxiety and depression caused by hospitalization in children aged 6 to 12 years in Dezful
Public title
The effect of dear child on depression anxiety in hospitalized children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is hospitalized in the pediatric ward.
The patient is conscious and has mental stability
between 6 to 12 years old.
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
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 Gachsaran Islamic Azad University
Street address
Islamic Azad University of Gachsaran
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581863876
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.IAU.IAUG.REC.1400.006
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Anxiety
Timepoint
when admitted, 48 hours after admission, at discharge
Method of measurement
Revised Reynolds and Richmond Children's Manifest Anxiety Scale
2
Description
Depression
Timepoint
when admitted, 48 hours after admission, at discharge
Method of measurement
Maria Kwas Children's Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:A dear child is considered for the intervention group.she is with the child every morning until noon and performs all aggressive procedures and supportive measures .she also approaches the child using communication techniquse, play therapy, storytelling and painting
Category
Behavior
2
Description
Control group: no intervention is performed for the control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Ganjavian hospital
Full name of responsible person
Fateme Mohtadi
Street address
Gangavian Hospital, Andimesh road to Dezful
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 2043
Email
bbd@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice Chancellor for Research, Islamic Azad University of Dezful
Street address
Islamic Azad University of Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0601
Email
info@iaud.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
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
Islamic Azad University
Full name of responsible person
Fateme Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0601
Email
fatememohtadi713@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0601
Email
fatememohtadi713@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
0098 61 424220601
Email
fatememohtadi713@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
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
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
12 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
According to the terms and conditions of Dezful Azad University, the data can be used
From where data/document is obtainable
Fateme Mohtadi
fatememohtadi713@gmail.com
What processes are involved for a request to access data/document
Written request and consent of the Executor of the project and colleagues