Objectives: Aim of this study is Effect of painting on the anxiety of hospitalized cancer children. Design: This clinical trial is a randomized, 2 phases and the study phase is parallel and triple-blind that number of samples that have including criteria selected. Including criteria: Hospitalized children with cancer that have 9 to 12 years old. Setting and Conduct: The anxiety questionnaire will be given to children, then with random block anxious children are divided into two groups, intervention and control group, and after intervention, the questionnaire will be completed by the children. Intervention: The intervention stage performances painting 6 sessions per day during the second and third and quarters of hospitalized children with cancer in the hospital in the morning and evening and Each time for 1 hour. Main outcome measures: Anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070113826N1
Registration date:2015-11-18, 1394/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Neda Sheikhzakaryaie
Name of organization / entity
Kurdestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 5280
Email address
n.zakaryaie@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kurdistan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of painting on the anxiety of hospitalized cancer children
Public title
Paintings on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: Children's with cancer in Besat hospital in Sanandaj that have 9 to 12 years old and have the normal mental status; Children 12-9 years of age with cancer; Children that stay in hospital and have a file there; The anxiety score more than average, according to Spielberger anxiety scale; Volunteers to participate in the test
Exclusion criteria: Critically ill children who are not able to participate in painting sessions; Children who are less than 4 days stay in hospital; Children with mental health problems are diagnosed before
Age
From 9 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Intervention in random blocks
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran street, Sanandaj
City
Sanandaj
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
muk.rec.1392.30
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C00-D48
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
anxiety
Timepoint
before and after intervention
Method of measurement
Spil berger questionnaire
Secondary outcomes
1
Description
not
Timepoint
not
Method of measurement
not
Intervention groups
1
Description
Intervention group: Drawing in 6 times, a second, third and fourth days of hospitalization for children with cancer in the hospital during chemotherapy, in the morning and evening and each time will be 1 hour. For the intervention the master of Psychology will help that the drawing tools include colored pencils, crayons, pencils and markers will be provided to these children that painting their favorite things on paper.
Category
Other
2
Description
Control group: In the control group will not perform any special action. The intervention and control groups are in separate rooms, when talking to each other does not effect on the other group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Neda Sheikhzakaryaie
Street address
Keshavarz street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
dr. Ghaderi
Street address
Pasdaran street
City
Sanandaj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
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
Kurdistan University of Medical Sciences
Full name of responsible person
Neda Sheikhzakaryaie
Position
MS
Other areas of specialty/work
Street address
Pasdaran street, Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 3182 7443
Fax
Email
n.zakaryaie@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Neda Sheikhzakaryaie
Position
MS
Other areas of specialty/work
Street address
Pasdaran street, Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 3182 7443
Fax
Email
n.zakaryaie@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Neda Sheikhzakaryaie
Position
MS
Other areas of specialty/work
Street address
Pasdaran street, Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 3182 7443
Fax
Email
n.zakaryaie@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)