The present study determines effect of painting on anxiety of hospitalized children. Study population is children aged 6 to 12 years old that are hospitalized at Tehran children’s medical center. Sample size consists of 72 children who were hospitalized for 6 days without receiving any tranquilizer. Participants through applying simple random sampling are divided into 2 groups (experimental group and control group) consisting of 36 persons. The intervention was painting with free topic at experimental group. Control group is similar to experimental group but control group only benefit from routine medical care in Hospital. Immediately upon performing intervention, it is applied from the Revised Children’s Manifest Anxiety scale in order to assess level of child’s anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101245687N1
Registration date:2013-07-27, 1392/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-27, 1392/05/05
Registrant information
Name
Mina Nooraliee
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7773 2434
Email address
m-nooraliee@students.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Science Vice Chancellor For Research
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Painting Compared with Routine medical care in Hospital On Anxiety Of Hospitalized Children Aged 6 To 12 years old
Public title
The Effect Of Painting On Children’s Anxiety aged 6 to 12
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: hospitalization for at least 6 days, having mental health, required consciousness level required (up to the level that does not prevent doing research).
Exclusion criterion: Patient’s acute status (for any reason)
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:
72
Randomization (investigator's opinion)
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 Tehran University Of Medical Science
Street address
Pur sina St., keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
91-03-61-19038-71355
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
f41.1,f93.
ICD-10 code description
Separation anxiety disorder of childhood,Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and after the final intervention
Method of measurement
Revised Children's Manifest Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group has 36 children aged 6 to 12 years old. The topic is free painting at experimental group. The equipment offered to child is including: paper, colorful pencil, and crayon in different colors. The painting intervention is performed for 5 consecutive days each session lasting for 25min to 35min. The criterion of assessing anxiety in this research is the Revised Children’s Manifest Anxiety scale that was completed before the first intervention and after the final intervention.
Category
Treatment - Other
2
Description
The control group consisting of 36 children aged 6 to 12 years is similar to experimental group and only intervention is not performed for them. They only benefit from routine medical care in hospital.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children’s Medical Center
Full name of responsible person
Mina Nooraliee
Street address
Near Imam Khomeini Hospital, Doctor Gharib St., the end of keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Science Vice Chancellor For Research
Full name of responsible person
Doctor Akbar Fotuhi
Street address
Fourth floor, Center Organization Of Tehran University Of Medical Science, Ghods St., Keshavarz Blvd.
City
Tehran
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 Science Vice Chancellor For Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical science
Full name of responsible person
Mina Nooraliee
Position
Nursing bachelor student
Other areas of specialty/work
Street address
Pur sina St., Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 8892 6175
Fax
Email
mina.nooraliee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and midwifery
Full name of responsible person
khadije zarei
Position
Faculty member, master of nursing
Other areas of specialty/work
Street address
East nosrat st.,Tohid sq.,Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zareiikh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical science
Full name of responsible person
Mina Nooraliee
Position
Nursing Bachelor student
Other areas of specialty/work
Street address
Pur sina St., Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 8892 6175
Fax
Email
mina.nooraliee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)