Protocol summary

Study aim
ِِDetermination of the effect of painting on children's anxiety before surgery in the operating room of Alzahra Hospital in Isfahan in 2017
Design
a controlled trial, parallel Two arm parallel group none-randomized controlled trial and open-labile
Settings and conduct
In this study, the children who referred to the operating room in Alzahra hospital,Isfahan, Iran were assigned to control and experimental groups based on weekly visits. After the presentation of the research aims for the parents the researcher completed the anxiety questionnaire . After completing the informed consent form by the parents in the intervention group, 15 minutes were taken to draw the painting. There was no intervention in the control group. In order to increase the accuracy, the researcher completed the questionnaire before and after the intervention by observing the child's behavior
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 3 to 7 years ; undergoing surgery in Alzahra Hospital in Isfahan ; Consent Inform from parents and children Exclusion criteria:The child with a Cognitive disability is confirmed by the parents; The child with a mental illness is confirmed by the parents
Intervention groups
In this study, 70 children aged 3 to 7 years undergoing surgery were randomly allocated into intervention and control groups (n = 35). The children in the intervention group painted in the preoperative room and their anxiety was measured before and after painting. There was no intervention in the control group except for routine interventions. The data collection tool consisted an Anxiety questionnaire
Main outcome variables
children's anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171118037521N1
Registration date: 2018-04-02, 1397/01/13
Registration timing: retrospective

Last update: 2018-04-02, 1397/01/13
Update count: 0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
narges Sadeghi
Name of organization / entity
Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4058
Email address
narges_sadeghi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-07-22, 1396/04/31
Actual recruitment start date
2017-05-21, 1396/02/31
Actual recruitment end date
2017-08-15, 1396/05/24
Trial completion date
empty
Scientific title
The effect of Painting on Children's Anxiety before Surgery in the Operating Room
Public title
The effect of painting on children's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range was 3 to 7 years. The ability to communicate verbally The ability to draw paintings Conscious Consent of Parents and Children
Exclusion criteria:
The child with a Cognitive disability is confirmed by the parents The child with a mental illness is confirmed by the parents
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
This study has not been randomized.
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 Islamic Azad University
Street address
Isfahan (Khorasgan) Branch, Arghavanieh, Jey St; Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.IAU.KHUISF.REC-1396-2-3

Health conditions studied

1

Description of health condition studied
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Percentage of people with decreasing anxiety
Timepoint
When entering the room before surgery, and about 20-15 minutes after attending the desired room
Method of measurement
Yale Preoperative Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, after obtaining informed consent from the family and the child, in the per-operative room, drawing equipment such as color pencil and simple painting notebook were placed in a suitable place. The children painted in the preoperative room. The minimum waiting time for entering the operating room was 15 minutes. The children of the intervention group painted at least 15 minutes. The children's anxiety questionnaire completed before and after children painting by the researcher.
Category
Prevention

2

Description
Control group: In this group, after obtaining informed consent from the family and the child, before the surgery and 15 minutes later, the children's anxiety questionnaire was completed by the researcher. There was no intervention in this group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Narges Sadeghi
Street address
Islamic Azad University Isfahan Branch (Khorasgan) Arghavanieh, Jey St; Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4059
Email
narges_sadeghi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Sadeghi
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Arghavanieh, Jey St; Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4059
Fax
+98 31 3535 4065
Email
n45sadeghi@yahoo.com
Web page address
Grant name
Isfahan Islamic Azad University
Grant code / Reference number
000000
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
Narges Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Arghavanieh, Jey St; Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4059
Email
narges_sadeghi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Arghavanieh, Jey St; Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4059
Email
narges_sadeghi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Arghavanieh, Jey St; Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4059
Fax
Email
n45sadeghi@yahoo.com
Web page address

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
there isn't more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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