Comparison of the effectiveness of two methods of distraction with Animation cartoon and distraction cards on pain Perception after Blood sampling and parental satisfaction in children 3-6 years
Comparison of the effectiveness of two methods of distraction with Animation cartoon and distraction cards on pain Perception after Blood sampling and parental satisfaction in children 3-6 years
Design
This clinical trial involving 90 children that randomly allocated in three groups of 30 people in Animation cartoon intervention group,30 people in distraction cards intervention group and 30 people in control group .
Settings and conduct
Children's departments of Akbar Children's Pediatric Hospital
Participants/Inclusion and exclusion criteria
Entry Criterion:
•Children 3-6 years
•The child has no mental or psychological problem according to the doctor's diagnosis.
•The absence of acute and severe pain or the need for urgent emergency procedures, according to the diagnosis of the doctor in charge of treatment.
•Presence of a physician's written instruction for blood sampling
5.Parental presence
No entry Criterion:
•Have neuro-developmentally delayed
•Have vision and hearing impairment and verbal difficulties
•He used analgesic Such as phenobarbital and diazepam 6 hours before blood sampling
Intervention groups
In animation cartoon intervention group, animation cartoon display is used 5 minutes before blood sampling until the end of blood sampling. In intervention group of distraction cards, distraction cards is used From start to end of blood sampling .
Blood sampling in the control group without intervention.
Main outcome variables
Pain Perception after Blood sampling and parental satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171110037347N1
Registration date:2019-01-03, 1397/10/13
Registration timing:retrospective
Last update:2019-01-03, 1397/10/13
Update count:0
Registration date
2019-01-03, 1397/10/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38413007
Email address
ebrahimzadehz941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
2018-04-03, 1397/01/14
Actual recruitment end date
2018-07-01, 1397/04/10
Trial completion date
2018-07-01, 1397/04/10
Scientific title
Comparison of the effectiveness of two methods of distraction with Animation cartoon and distraction cards on pain Perception after Blood sampling and parental satisfaction in children 3-6 years
Public title
Effect of Cartoon Animation and Distraction Card on Reducing the Pain of Children 3-6 Years Blood sampling and Parental Satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
children 3-6 years
The child has no mental or psychological problem according to the doctor's diagnosis.
The absence of acute and severe pain or the need for urgent emergency procedures, according to the diagnosis of the doctor in charge of treatment.
Presence of a physician's written instruction for blood sampling
Parental presence
Exclusion criteria:
Have neuro-developmentally delayed
Have vision and hearing impairment and verbal difficulties
He used analgesic Such as phenobarbital and diazepam 6 hours before blood sampling
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery using blocking
The lottery by blocking is that we have three groups
A = animation cartoon group
B = Band of Deviation cards
C = control group
So we have 6 modes for sample selection: ABC-ACB-BAC-BCA -CAB -CBA
By dropping these dice, it will be determined how the sampling procedure is organized, for example by removing the ACB dice first by intervening in the animation cartoon group, then in the control group, and then in the distraction card group.
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.MUMS.REC.1396.368
Health conditions studied
1
Description of health condition studied
Distraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain perception after blood sampling
Timepoint
After Blood sampling and two minutes after Blood sampling
Method of measurement
Wong and Baker pain tool
2
Description
Parental satisfaction
Timepoint
After blood sampling
Method of measurement
Parental satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The executive protocol in the animation cartoon First intervention group is such that after the child He was guided to blood sampling room .The second nurse communicates with the child and then Displayed an animated cartoon Using the tablet 5 minutes before blood sampling It continues until the end of the blood sampling. Blood sampling will be done by the first nurse.
Category
N/A
2
Description
The executive protocol in the distraction cards Second intervention group is such that after the child guided to blood sampling room .The second nurse communicates with the child and showed the cards to the child(the distraction cards is that distraction cards are cards of dimensions 5 by 8 cm, with various shapes and images, and questions based on the age of the child behind the screen) and told the child that "You can answer my questions if you pay attention to the cards carefully." When the child begins to look carefully at the card, the first nurse starts to take blood and the second nurse begins to ask questions during until end blood sampling, such as "How many babies are you in the picture?" Or " All the boars have a few points? " , "Can you see the filo in your picture?", "How many monkeys do you see in the picture?" etc.
Category
N/A
3
Description
Control group: Blood sampling in the control group will be performed routinely without intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar mashhad children's hospital
Full name of responsible person
Ebrahimzadeh zeinab
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Ebrahimzadehz941@mums.ac.ir
Web page address
http://www.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Ebrahimzadehz941@mums.ac.ir
Web page address
http://www.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
Ebrahimzadeh zeinab
Position
Master of child nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
کد پستی : 13944-9138
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Ebrahimzadehz941@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ebrahimzadeh zeinab
Position
Master of child nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
کد پستی : 13944-9138
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Ebrahimzadehz941@mums.ac.ir
Web page address
https://mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ebrahimzadeh zeinab
Position
Master of child nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
کد پستی : 13944-9138
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Ebrahimzadehz941@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
By request by valid email
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
By request, by email and the destination will be available to people