Determining the effect of painting therapy on anxiety and coping strategies of children hospitalized in Akbar children's hospital
Design
A randomized clinical trial with two groups of intervention and control group, Using the lottery the control group was sampled first and then the intervention group sampling was started
Settings and conduct
This study was conducted at the Akbar children's hospital.The intervention group participated in a group for 5 sessions of 1hour therapeutic use of painting in the game room. Sessions were conducted on the basis of theme-oriented method by the researcher and in relation to topics including: Free(session 1), Patient feelings about the hospital and its environment(Session 2), Illness and patient(Session 3), Care team including nurses and doctors(Session 4), Treatment services and procedures(Session 5). In each session, after brief explanation, the painting tools(crayons, watercolors, pastels, markers, and in the fourth session the gouache) was provided as a package to the child. The child painted on the theme assigned. At the end of each session, the researcher asked the child to design a story for his painting. At the 3rd session, children were asked to play a show of their story with cutting off the characters and gluing them on a craft stick.The 4th session was painting on the wall with a brush and syringe and 5th session was coloring.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 7 to 12 years
Non-inclusion criterion: Isn't in the first 24 hours of admission; History of admission; Anxiety score of below 19; Mental retardation, Down syndrome and cognitive impairment; Inability to leave the bed
Intervention groups
Intervention group: painting, five sessions, with theme-oriented method, each session 1hour, two sessions a day
Control group: No intervention received
Main outcome variables
Anxiety; Coping Strategy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039799N1
Registration date:2018-12-30, 1397/10/09
Registration timing:retrospective
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Mehri Miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 8513
Email address
mirim931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2018-11-22, 1397/09/01
Trial completion date
2018-12-11, 1397/09/20
Scientific title
Effect of therapeutic application of painting on hospitalization anxiety and coping strategies on hospitalized children
Public title
Effect of painting therapy on hospitalization anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child should be hospitalized
The child's age should be between 7 and 12 years old
Exclusion criteria:
The child should not leave the bed
The child is not in the first 24 hours of admitting
The child has a previous history of admission
The child will be discharged from the hospital in less than 3 days
The child has an anxiety score of less than 19
The child has mental retardation, Down syndrome and known cognitive impairment
Parents and child are not willing to participate in the study
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:
60
Actual sample size reached:
60
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
Research Ethics Committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ebne Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.MUMS.REC.1397.037
Health conditions studied
1
Description of health condition studied
Hospitalized children's Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Children that scored more than 19 in Anxiety score in Revised Children Manifest Anxiety Scale (RCMAS)
Timepoint
Measure anxiety before and immediately after the intervention
Method of measurement
Revised Children Manifest Anxiety Scale
2
Description
Coping strategies in Coping Strategies Inventory-Short Form
Timepoint
Checking coping strategies before and immediately after the intervention
Method of measurement
Coping Strategies Inventory-Short Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Art painting (painting), five sessions, with theme-oriented method, each session 1 hour, two sessions a day
Category
Rehabilitation
2
Description
Control group: Filling the Revised Children Manifest Anxiety Scale and Coping Strategies Inventory-Short Form on Day 1 and 3 and they receive only routine interventions in the duration of hospitalization
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar children's hospital
Full name of responsible person
Dr Ali Khakshour
Street address
In front of No. 14, Shahid Kaveh Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3871 3801
Email
akbar@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Research Chancellor, In front of No.18, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mehri Miri
Position
MSc. Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3852 8513
Fax
Email
mirim931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebeh Reyhani
Position
Instructor of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
reyhanit@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehri Miri
Position
MSc. Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mirim931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Only the article will be published
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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