The present study is a single-blind RCT study which aims to determine the effect of distraction on the intensity of second grade burn dressing change in 3-6 year-old children will be admitted to Zareh hospital in 2015. The research environment is Zareh hospital burn unit. The study population consisted of all children suffering from 2nd degree burns that treatment will be in the burn unit of Zareh hospital. Samples selected by available sampling and 3-6 year-old children were assigned to control group and distraction group by random sampling based on the table of random numbers. For the experimental group, 3 minutes before the dressing [18], distraction started by displaying a game on a portable monitor and continued until the end of dressing change and in the control group, dressing change will be done without any intervention. One of the parents will be attended during the procedure in both groups. Data collection tools in this study will be demographic and medical information questionaires (Gender, age, weight, percentage of body burns and the burned organ) and behavioral pain scale for children (Flacc scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111425029N1
Registration date:2016-03-06, 1394/12/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-06, 1394/12/16
Registrant information
Name
Sima Kaheni
Name of organization / entity
Faculty of nursing and medvifry, Mazandaran University of Medical Sciences, Sari, Iran
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
s.kaheni@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Distraction Technique on the Pain of Dressing Change in 3-6 Year-old Children
Public title
The effect of Distraction Technique on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were the age of child (beginning of third year to the end of sixth year); 2nd degree burns; 9-35% body surface burns; alertness to place; time and person; having the ability to communicate; non-verbal and auditory disorders; absence of acute and chronic diseases; and the presence of a parent with the child. In the event of a life-threatening emergency, samples excluded from the study.
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences,sari,Iran
City
sari
Postal code
4816715793
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.MAZUMS.REC.94-1410-
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T32.3
ICD-10 code description
Corrosions involving 30-39% of body surface
Primary outcomes
1
Description
pain
Timepoint
Before and during the intervention
Method of measurement
Flacc scale
Secondary outcomes
empty
Intervention groups
1
Description
For The intervention group of 3 minutes before the dressing change, distraction using a portable monitor through a game show for children will continue till the end of the dressing change.
Category
Other
2
Description
in the control group, dressing change will be done without any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
zarea Martyr Hospital
Full name of responsible person
sima kaheni
Street address
zarea Martyr Hospital, Taleghani Blvd, Sari, Iran
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Ahmad Ali Enayat ,Deputy of Research and Technology,Moallem Field,Sari, Iran ,
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences,faculty of nursing and medwifery Sari, Iran
Full name of responsible person
sima kaheni
Position
master degree/Faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences,faculty of nursing and medwifer
City
sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
s.kaheni@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran
Full name of responsible person
Masoumeh Bagheri Nsamy
Position
Phd/faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Sari, Iran
City
sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
mbagheri@mazums.ac.iranna۳۰۴۳@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran
Full name of responsible person
sima kaheni
Position
master degree/Faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Sari, Iran
City
sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
s.kaheni@mazums.ac.irkaheni2012@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)