Comparison of the effect of two active ( game)and inactive (music) distraction methods on pain intensity of burning dressing in children 3-6 years old
Design
The clinical trial has two intervention groups ( computer game and music) and a control group, with parallel group design and non-randomized allocation. Sample size is 120 kids including 40 person in each group.
Settings and conduct
The intervention will be performed in the waiting room and dressing room of Shahid Motahari Burn Hospital. Only the statistician will not be aware of the type of intervention performed in each group and the data will be given to groups A, B, and C.
Participants/Inclusion and exclusion criteria
Inclusion criteria: burn extent equal to 9-35%; lack of hearing and visual impairment; Non-burn in one hand; No have other pain.
Non - inclusion criteria: Burn with electrical, chemical and bitumen things; perineal, head and neck burns; insensibility in the burn area.
Intervention groups
First intervention group: The child will play with the tablet 10 minutes before entering the dressing room until the dressing is completed and his or her pain and anxiety will be measured before and during the dressing change.
Second intervention group: The child will listen to his/her favorite music from 10 minutes before entering the dressing room until the dressing is completed and his/her pain and anxiety will be measured before and during the dressing change.
Control group: The child will receive no routine care intervention. Both pain and anxiety will be measured before and during dressing change.
Main outcome variables
Pain; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N8
Registration date:2019-10-22, 1398/07/30
Registration timing:retrospective
Last update:2019-10-22, 1398/07/30
Update count:0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of active and inactive distraction methods on burn pain severity and anxiety in children.
Public title
Effect of distraction methods on burn pain in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Burnout size 9-35%
do not have other acute or chronic diseases without burning
do not have hearing and visual impairment
Lack of cognitive impairment
Non-burn in one hand to play with game
Do not have pain without pain of burning
Lack of burn experience in the past
Exclusion criteria:
Burns with electricity, chemicals and bitumen
Perineal and head and neck burns
Anesthesia is the location of the burn because of its wide depth
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:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Analysis will be done without the knowing intervention types in the groups .the Groups will be marked with with A, B,C
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of Nursing and Midwifery.,Shahid Yasemi Street., North Kordestan highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.715
Health conditions studied
1
Description of health condition studied
Pain, Anxiety
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention- During intervention
Method of measurement
visual analog scale
2
Description
Anxiety
Timepoint
Before intervention- During intervention
Method of measurement
Observational Scale of Behavioral Distress
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: listening to favorite music from 10 minutes before entering the dressing room until end of dressing change .
Category
Behavior
2
Description
Second intervention group: playing with tablet games from the 10 minutes before entering the dressing room until the end of dressing change.
Category
Behavior
3
Description
Control group: not receiving any intervention. Only routine care will perform during dressing change .
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Burn Rescue Hospital
Full name of responsible person
Roghaye Samimi
Street address
Faculty of Nursing and midwifery , Shahid Yasemi Street, Kodestan highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8877 0031
Fax
+98 21 8877 0048
Email
hospital.motahari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seid Kazam Malakuti
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran., IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
PR@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
Mahnaz Shoghi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid yasemi Street, Kordestan highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran