A randomized clinical trial is proposed for investigating the effect of playing with toys on the severity of pain during burn dressing change in 3-6 year-old children presenting to Shahid Motahari Burns Hospital for their first burn dressing change.
After obtaining the ethics approval for conducting the study, 78 children are placed in control and intervention groups. The FLACC scale is used in both groups to measure the severity of pain before and during the dressing (upon removing the previous dressing) and the arterial blood oxygen level and pulse are then measured by a pulse oximeter. In the intervention group, the child learns about the dressing steps 15 minutes before starting the procedure using a doll that has burns and with the help of the child who uses toy dressing to dress the doll; the child gets to keep the doll as his own dressing begins. In the control group, dressing is performed as is the routine.
The data pertaining to pain, pulse and arterial blood oxygen level are recorded in both groups before and during dressing and are then compared. To achieve a blinded study, a research assistant performs the observations and records the data.
The measured pain, pulse and arterial blood oxygen level are ultimately compared between the control and intervention groups. Each child receives a gift at the end of the dressing. Informed consents will be obtained from the parents of all the participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602281788N15
Registration date:2016-05-06, 1395/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Center for Nursing Research Iran University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of play on young children pain during burn wound care
Public title
The effect of play on young children pain during burn wound care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion :
Girls and boys؛ aged 3-6 years old؛ no auditory or visual impairment, no mental retardation؛ capable of establishing verbal communication؛ no pain except the burn pain؛ receiving no painkillers.
Exclusion:
Burns with chemicals, electricity or bitumen؛ burn in the perineum, head or neck area
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:
78
Randomization (investigator's opinion)
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 University Of Medical Sciences
Street address
Shahid Hemmat Highway، Tehran
City
Tehran
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.IUMS.REC.1394.9311687009
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, at the end of intervention
Method of measurement
Scale flacc
Secondary outcomes
1
Description
Pulse
Timepoint
Before avd After Dressing
Method of measurement
Pulse oximetry
2
Description
Arterial Oxygen Saturation
Timepoint
Before avd After Dressing
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Dressing steps are taught to the child 15 minutes before they start dressing in the intervention group، a doll with a burn, which is finally given to the child, is first dressed using toy dressing with the help of children themselves، Then the children’s dressing is performed.
Category
Behavior
2
Description
The dressing is performed routinely in the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haspital martyr Motahhari Iran University of Medical Sciences and Health