Protocol summary

Study aim
Comparison of the effect of virtual reality and animation on pain control due to injections in children 3 to 6 years old.
Design
The clinical trial consisted of two intervention groups, one control group, single -blind and randomized on135 children 3 to 6 years old. Children are assigned to groups based on a randomization sequence and first in first out that will be generated in advance, which is unpredictable and has no certain pattern. To assign samples to 3 groups, the block randomization method with the size of 3 and 6 blocks using block random number generator software will be used. All this will be done with software called Sealed Envelope.
Settings and conduct
This study will be performed in health centers of Arak city. A demographic information questionnaire will be collected through interviews. The child is filmed during the procedure and the pain level is measured using the Wong-Bakar Faces pain rating scale. eventually, data analysis is performed using SPSS 20 program. Only data analyzers will not know how the samples are placed in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 3 to 6 years old without underlying disease and lack of vision and hearing problems. Exclusion criteria: Child parents' unwillingness to participate in the study.
Intervention groups
First intervention group: In this group, from the beginning of the injection procedure to the end of the procedure, we use the virtual reality technique using 3D glasses to view Sponge Bob animation. Second intervention group: In this group, using a mobile phone, from before the injection procedure to its end, the Sponge Bob animation is displayed. Control group: In this group there is no intervention, only the injection will be performed.
Main outcome variables
Intensity of pain

General information

Reason for update
Acronym
_
IRCT registration information
IRCT registration number: IRCT20210501051142N1
Registration date: 2021-09-08, 1400/06/17
Registration timing: prospective

Last update: 2021-09-08, 1400/06/17
Update count: 0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-01-15, 1400/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of virtual reality and animation on pain control due to injections in children 3 to 6 years old.
Public title
"The effect of virtual reality and animation on pain control due to injections "
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying disease in the child. Child parents' willingness to participate in the study.
Exclusion criteria:
Existence of vision and hearing problems in the child.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Children are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 and 6 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 and 6 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate children. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 and 6 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement.
Placebo
Not used
Assignment
Parallel
Other design features
_

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak university of medical sciences
Street address
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2021-07-25, 1400/05/03
Ethics committee reference number
IR.ARAKMU.REC.1400.076

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intensity of pain
Timepoint
During intervention
Method of measurement
Pain is measured by the Wong-Bakar Faces pain rating scale.

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: In this group, from the beginning of the injection procedure to the end of the procedure, we use the virtual reality technique using 3D glasses to view Sponge Bob animation and during the procedure, the child is filmed for a more comprehensive examination.
Category
Other

2

Description
Second intervention group: In this group, using a mobile phone, from before the injection procedure to its end, the Sponge Bob animation is displayed. During the procedure, the child is filmed for a more comprehensive examination.
Category
Other

3

Description
Control group: In this group there is no intervention, only the injection will be performed and the child will be filmed during the injection procedure for a more comprehensive examination.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Arak city
Full name of responsible person
Mahbobeh Sajadi
Street address
Basij Sq., Sardasht region, Arak university of medical sciences
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3493 4634
Email
golmehrsherafati@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3493 4634
Email
golmehrsherafati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
80
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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
since the winter of 2022
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
In order to control pain in children when injecting
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences.
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