Protocol summary

Study aim
The efficacy of cartoon playing in pediatric suturing pain relief among children of 3-6 year old in the Emergency
Design
The study is a clinical trial. 109 children aged 3 to 6 years with trauma in the emergency department are selected by random sampling.
Settings and conduct
Children 3 to 6 years old, regardless of age and sex, who need suturing need to be sutured, enter the treatment / suturing / dressing room with a parent after triage and filing. The child's favorite cartoon is then played through 3D glasses. And after 3-5 minutes, the procedure begins.
Participants/Inclusion and exclusion criteria
Children 3 to 6 years, Parental satisfaction Confirm the need for stitches
Intervention groups
Children will be randomly divided into two groups. The intervention group, in addition to local anesthesia, will also have a cartoon broadcast for them, and the control group, for which a cartoon will not be broadcast. The amount of pain in the child before and after the procedure in both intervention and control groups will be questioned and the two groups will be compared with each other.
Main outcome variables
pain

General information

Reason for update
Acronym
درد
IRCT registration information
IRCT registration number: IRCT20201118049429N1
Registration date: 2022-03-05, 1400/12/14
Registration timing: registered_while_recruiting

Last update: 2022-03-05, 1400/12/14
Update count: 0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Sanaz Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4424 3034
Email address
dr.yazdanisa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cartoon playing in pediatric suturing pain relief among children of 3-6 year old in the emergency
Public title
The efficacy of cartoon playing in pediatric suturing pain relief among children of 3-6 year old in the emergency
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 3 to 6 years Parental satisfaction Confirmation of the need for sutures
Exclusion criteria:
Mental disability Childhood diabetes Treated mental illness Hearing impairment Visual impairment Speech disability physical disability
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: 109
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
Iran national committee for ethics- IUMS
Street address
Iran university of medical sciences ,Hemmat Highway, next to Milad Tower ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.IUMS.FMD.REC.1400.100

Health conditions studied

1

Description of health condition studied
initial traumatic wound repair
ICD-10 code
T81.33XA
ICD-10 code description
Disruption of traumatic injury wound repair, initial encounter

2

Description of health condition studied
forearm open wound
ICD-10 code
S51.80
ICD-10 code description
Unspecified open wound of forearm

3

Description of health condition studied
thigh open wound
ICD-10 code
S71.10
ICD-10 code description
Unspecified open wound of thigh

4

Description of health condition studied
hand open wound
ICD-10 code
S61.40
ICD-10 code description
Unspecified open wound of hand

5

Description of health condition studied
scalp open wound
ICD-10 code
S01.00
ICD-10 code description
Unspecified open wound of scalp

6

Description of health condition studied
ankle open wound
ICD-10 code
S91.00
ICD-10 code description
Unspecified open wound of ankle

Primary outcomes

1

Description
pain
Timepoint
from the beginning of the suture till the end of suturing
Method of measurement
FLACC scale

Secondary outcomes

empty

Intervention groups

1

Description
Children 3 to 6 years old enter the suture room after triage. For the intervention group, in addition to local anesthesia, the child's favorite cartoon is played through 3D glasses. And after 3-5 minutes, the procedure begins.
Category
N/A

2

Description
Control group: In the control group, only routine care (washing, anesthesia and suturing of the wound site is performed. The cartoon is not broadcast.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Sanaz Yazdani
Street address
Rasoul Akram Hospital ,Niyayesh St, Sattarkhan St, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
dr.yazdanisa@gmail.com
Web page address
https://hrmc.iums.ac.ir/

2

Recruitment center
Name of recruitment center
Shohaday-e-Haftom-e-Tir Hospital
Full name of responsible person
Sanaz Yazdani
Street address
Shohaday-e-Haftom-e-Tir Hospital,South Shahid Rejaee Street, Shar-e-Rey,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
۱۸۸۶۷۱۸۱۳۶
Phone
+98 21 5522 8581
Fax
+98 21 5521 7901
Email
web۷tir@iums.ac.ir

3

Recruitment center
Name of recruitment center
Firoozabadi Hospital
Full name of responsible person
Sanaz Yazdani
Street address
Firoozabadi Hospital ,Fadaian Eslam St, Shahr-e-Rei ,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1849794113
Phone
+98 21 5104 8000
Email
hospfa@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Fax
+98 21 8862 2703
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Emergency Medicine Specialist/Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۵۳۵ - ۱۴۴۹۶
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
h.r.khoshnezhad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Emergency Medicine Specialist/Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۵۳۵ - ۱۴۴۹۶
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
h.r.khoshnezhad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sanaz Yazdani
Position
Emergency Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۵۳۵ - ۱۴۴۹۶
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
dr.yazdanisa@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data is encrypted in order to make individuals' identifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr Hamidreza Khoshnezhad Ebrahimi
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.
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