Comparison of the effect of two methods of using toys with medical materials and visual distraction on pain and anxiety during intravenous cannulation in children admitted
Determining and comparing the effect of two methods of toys with medical devices and visual distraction on the intensity of pain and anxiety during venous catheter insertion in children admitted to Ba'ath Medical Education Center in Hamadan
Design
Clinical trial with control group, with parallel groups, single-blinded, randomized, in 150 patients. Allocation was randomized using a block table.
Settings and conduct
Pain during insertion of intravenous catheter in children aged 3-6 years old in Hamadan Besat Medical Center is noted by researcher based on Vang-Baker scale and anxiety based on facial instrument for assessing children's anxiety at the time of insertion of intravenous catheter for each patient. 5 minutes before inserting the venous catheter, in the groups of visual distraction and toys with medical devices, cartoons and games with medical devices, respectively, start and continue until the vein is fixed. There is no intervention in the control group. In this study, the statistical consultant will be blinded by numbering the groups 1 to 3.
Participants/Inclusion and exclusion criteria
An intravenous catheter must be placed in all children admitted to the emergency department or internal paediatric units,In critical cases, such as cardiopulmonary resuscitation or seizures, there is no need to place a venous catheter and...
Intervention groups
Intervention group 1: Visual distraction by playing cartoons during insertion of a venous catheter
Intervention group 2: Playing with medical devices during the insertion of an intravenous catheter
Control group: Non intervention
Main outcome variables
Pain; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N10
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of using toys with medical materials and visual distraction on pain and anxiety during intravenous cannulation in children admitted
Public title
Comparison of the effect of two methods of using toys with medical materials and visual distraction on pain and anxiety during intravenous cannulation in children admitted
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
An intravenous catheter must be placed in all children admitted to the emergency department or internal paediatric units
In critical cases, such as cardiopulmonary resuscitation or seizures, there is no need to place a venous catheter and...
Exclusion criteria:
Lack of adequate cooperation (interruption of distraction for more than 2 minutes, agitation of the mother, etc.) on the part of the child and the child's parents
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected by convenience sampling method from patients' records.Then the Balanced Block randomization method will be divided into 3 groups of control (50 children), toys with medical devices (50 children) and visual distraction (50 children).
Blinding (investigator's opinion)
Single blinded
Blinding description
After entering the data, the study groups are numbered 1 to 3 by the researcher, and only numbers 1 to 3 are mentioned in spss, and the data are submitted to the reputable statistical consultant for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6561058582
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.UMSHA.REC.1402.388
Health conditions studied
1
Description of health condition studied
Pain during intravenous catheter insertion
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
2
Description of health condition studied
Anxiety during intravenous catheter insertion
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Pain
Timepoint
During intravenous catheter insertion
Method of measurement
Using the Wang Baker scale
2
Description
Anxiety
Timepoint
During intravenous catheter insertion
Method of measurement
State Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Visual distraction by playing cartoons during insertion of a venous catheter Intervention group
Category
Prevention
2
Description
Intervention group 2: Playing with toys with medical devices during the insertion of an intravenous catheter
Category
Prevention
3
Description
Control group: Non intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, pediatric Wards
Full name of responsible person
Zohreh Fateh
Street address
Besat Hospital, Besat Blvd., Hamedan
City
Hamadan
Province
Hamadan
Postal code
6561058582
Phone
+98 937 753 1808
Email
zohrehfateh75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3252 0683
Email
MR.shokohi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arash Khalili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517625432
Phone
+98 81 3838 0535
Email
arash5920@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arash Khalili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517625432
Phone
+98 81 3838 0320
Fax
+98 81 3838 0320
Email
arash5920@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arash Khalili
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517625432
Phone
+98 81 3838 0320
Fax
+98 81 3838 0320
Email
a.khalili@umsha.ac.ir
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