The present study was a clinical trial in 65 children 7-12 years old with cancer undergoing chemotherapy
Design
In this research, 65 children with cancer undergoing chemotherapy. samples were selected and randomly divided in to experimental (n=32) and control groups (n=33).
Settings and conduct
The study is a clinical trial in 65 children with cancer undergoing chemotherapy was admitted to Seyedoshohada hospitals in Isfahan. The data collection tool used was the Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale. In the experimental group, intervention was performed. After the intervention, the Questionnaire was completed again in both groups.
Participants/Inclusion and exclusion criteria
The Inclusion criteria: being in the age group of 7 to 12 years, having one type of cancer, being at least in the third stage of chemotherapy, having the ability to paint, lack of physical and mental retardation.
The exclusion criteria: unwillingness of the children and their families to continue to cooperate, children’s lack of ability to cooperate while studying, absence from 2 or more sessions of paintings, facing acute stress.
Intervention groups
the children who were in the intervention group participated in 6 group sessions of open watercolor painting lasting 25 minutes in the painting room. After 25 minutes, all children completed their paintings and explained their paintings to the researchers and other children. All the provided care in the control group was the same as the intervention group with the difference that the painting sessions were not held in this group.
Main outcome variables
fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035528N1
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Zahra Tahmasebi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3424 6333
Email address
tahmasebi.z@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan
Expected recruitment start date
2015-08-19, 1394/05/28
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of painting on fatigue in children with cancer undergoing chemotherapy admitted to Seyedalshohada hospital in Isfahan
Public title
The effect of Painting on fatigue in Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
the age group of 7 to 12 years (due to the ability to paint and respond to the questionnaire)
having one type of cancer
being at least in the third stage of chemotherapy
having the ability to paint and lack of physical and mental retardation
lack of physical problems and anxiety disorders
lack of use of psychotropic drugs or antidepressants.
Exclusion criteria:
unwillingness of the children and their families to continue to cooperate, children’s lack of ability to cooperate while studying, absence from 2 or more sessions of paintings, facing acute stress such as divorce of parents, death of parents or siblings, and changing of living location.
children’s lack of ability to cooperate while studying
absence from 2 or more sessions of paintings
facing acute stress such as divorce of parents, death of parents or siblings and changing of living location
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation (by draw)
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
Vice chancellor of research and technology, Isfahan University of Medical Sciences
Street address
Isfahan, hezar jarib Street, Isfahan University of Medical Sciences, University headquarters ,Building No. 4, Vice chancellor of research and technology
City
Isfahan
Province
Isfehan
Postal code
311081775
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
IR.MUI.REC.1394.3.413
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue
Timepoint
Before the intervention.after the intervention
Method of measurement
Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before starting the study, completed the questionnaire verbally. Then, the children who were in the intervention group participated in 6 group sessions of open watercolor painting lasting 25 minutes in the painting room. After 25 minut, all children completed their paintings and explained their paintings to the researchers and other children. Immediately after the intervention, the questionnaires were completed again.
Category
Other
2
Description
control group: Before starting the study, completed the questionnaire verbally. All the provided care in the control group was the same as the intervention group with the difference that the painting sessions were not held in this group, but the children sometimes painted in their rooms. Immediately after the intervention, the questionnaires were completed again
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of Hazrat Sayyid al-Shohada (AS) Isfahan
Full name of responsible person
Dr. Memarzadeh
Street address
Hospital of Hazrat Sayyid al-Shohada (AS) Isfahan
City
Isfahan
Province
Isfehan
Postal code
88861183
Phone
+98 31 3235 0214
Email
omid@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice-Chancellor of Research, Faculty of Nursing and Midwifer
Full name of responsible person
Dr. Kazemi
Street address
Isfahan, Hezar Jarib Street, Isfahan University of Medical Sciences, Vice-Chancellor of Research, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
81746-73261
Phone
+98 31 1668 7153
Email
research@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice-Chancellor of Research, Faculty of Nursing and Midwifer
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
Shahrekord University of Medical Sciences
Full name of responsible person
Zahra Tahmasebi
Position
Masters of Pediatric Nursing- Coach Training
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord, Shahrekord University of Medical Sciences, Borujen Nursing Faculty
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871948747
Phone
+98 38 3422 6333
Fax
Email
zahratahmasebi92@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Zahra Tahmasebi
Position
Masters of Pediatric Nursing- Coach Training
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord, Shahrekord University of Medical Sciences, Borujen Nursing Faculty
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871948747
Phone
+98 38 3424 6333
Fax
Email
zahratahmasebi92@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Zahra Tahmasebi
Position
Masters of Pediatric Nursing- Coach Training
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord, Shahrekord University of Medical Sciences, Borujen Nursing Faculty
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871948747
Phone
+98 38 3424 6333
Fax
Email
zahratahmasebi92@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available