Determining the effect of distraction by watching cartoons on the pain of preparation before suturing children in the emergency department
Design
Randomized controlled clinical trial with stratification solution and 86 patients in two groups of intervention and control and randomization with sealed envelopes
Settings and conduct
In the present study, there are two types of cartoons according to the age of children in the age groups of 3 to 6 years and 6 to 12 years. In the intervention group, from the time the child is placed on the bed until the end of the anesthetic injection, the cartoon will be broadcast and in the control group, the cartoon will not be broadcast. The study place is the emergency department of Bu Ali Sina Hospital in Sari
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 - Rupture in the face less than 3 cm that requires sutures
2- Having a child age of 3-12 years
3 - The presence of the mother next to the child
Inclusion criteria:
1- Mental disability
2- Hearing impairment
3- Visual impairment
4- Physical disability
5-Speech Disability
6- Treated mental illness
7- Childhood diabetes
8-Need sedation during suturing
9-Need analgesia during suturing
10- Ruptures sutured by students
11- Child neuromuscular diseases
12- Existence of sensory disorders in the child
13-Need sutures around the eyes
Intervention groups
Intervention group: Playing a cartoon with a tablet by the researcher starts from the time the child is placed on the bed for stitches and continues until the end of the anesthesia injection.
Control group: In this group, children are stitched according to the normal routine and cartoons are not broadcast for them.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N34
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cartoon distraction technique on pediatrics preparation pain before suturing in emergency department
Public title
The effect of cartoon distraction technique on pediatrics preparation pain before suture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Facial laceration less than 3 cm
Age of 3-12 years
The presence of the mother next to the child
Exclusion criteria:
Mental disability
Hearing impairment
Visual impairment
Physical disability
Speech disability
Treated mental illness
Childhood diabetes
A tear that needs sedation during suturing
A tear that needs analgesia during suturing
Ruptures sutured by students
Child neuromuscular diseases
Existence of sensory disorders in the child
Need sutures around the eyes
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that in this study, two groups A (intervention group) and group B (control group) have been designed, and since sampling should be done based on age and sex, so random sequence based on software by Stratified Block Randomization will be done so that 4 blocks, in the form of blocks 3 to 6 years old girl (11 people in group A and 11 people in group B), blocks 3 to 6 years old boy (11 people in group A and 11 people in group B), blocks 6 to 12 years old girl (11 people in group A and 11 people in group B) and 6 to 12 year old boys (10 people in group A and 10 people in group B). For allocation concealment, 86 opaque envelopes are embedded in the total number of samples, and the first 22 envelopes are numbered from 1 to 22, and the 3 to 6 year old girl is written on it, and the second 22 envelopes are numbered from 1 to 22 And on that block 3 to 6 years old boy is written and the next 22 envelopes are numbered from 1 to 22 and on that block 6 to 12 years old girl is written and the last 20 envelopes are numbered from 1 to 20 and on That block is written for 6 to 12 year old boys, in which A and B cards are placed based on the sequence of the data software.
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 Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, No 2 building, Mazandran University of Medical Sciences, Moalem street, Moalem square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.MAZUMS.REC.1399.698
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
For the intervention and control groups, once after bed rest and the second time during anesthesia injection
Method of measurement
Face Legs Activity Cry Consolability Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: According to the age of the child, the cartoon is played with the tablet, starting from the time the child is on the bed for suturing and washing the wound, and continues until the end of the anesthesia injection, and the pain is measured with an observational scale of pain behavior in these two stages. Injection of 2% lidocaine in both groups will be injected with a 2 cc syringe and a 23-gauge needle, depending on the child's weight, up to a maximum dose of 5 mg / kg. Two types of cartoons according to the age of children, and considering the Iranian Radio and Television poll among the most watched cartoons and short duration in two age groups of 3 to 6 years (some) with a duration of 8 minutes and in the age group 6 to 12 Year (Grape Gorilla), which lasts 10 minutes, will be broadcast. According to the available statistics, the cartoon of the 3 to 6 year old group was selected from among the most watched polls according to the poll, and the 6 to 12 year old cartoon because the most watched cartoons all had a long duration (about 20 minutes). A 10-minute cartoon was selected by the researcher.
Category
Behavior
2
Description
Control group: In the control group, children will be sutured according to the usual routine and no cartoons will be broadcast to them, and the pain will be measured in the same two stages, ie when the child is lying on the bed for suturing and washing the wound will be.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital, Sari
Full name of responsible person
Mohanna Arablarimi
Street address
Mazandaran University of Medical Sciences; Jouibar junction
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 6333 5819
Email
mohana.arablarimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Moalem Street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3397 8055
Email
Mohana.arablarimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
phd Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Reseach Assistant of Mazandaran University of Medical sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
mohana.arablarimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Baghri Nesami
Position
phd Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sari, Jouibar junction, Mazandaran University of medical science
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 1985
Email
Mohana.arablarimi@yahoo.com
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