Comparison of the Effect of Vision and Auditory Distractions on Physiologic Indicators and Pain of Dressing change in 6-12 Years Old Children at the Burn Center of Besat Hospital, 1397-98.
Comparison of the Effect of Vision and Auditory Distractions on Physiologic Indicators and Pain of Dressing change in 6-12 Years Old Children at the Burn Center of Besat Hospital.
Design
A total of 120 hospitalized children in the burning ward with available sampling will be selected from patients' files and then by randomized block assignment placed in a 3 groups clinical trial control, auditory distraction and visual distraction.
Settings and conduct
When changing dressing on the basis of self-reported pain scale, pain is noted for each patient by the researcher. 20 minutes before and 10 minutes after dressing, the physiological indexes of the units of study, including heart rate and arterial oxygen saturation, will be measured in each of the three control groups, visual distortion and auditory deviation, and recorded in special sheets. At the moment of changing the dressing, and then at intervals every two minutes until the end of the dressing, the physiological indicators are measured and recorded in special sheets, then the mean will be obtained and reported.
Participants/Inclusion and exclusion criteria
Lack of speech impairment and mental retardation, No burns in the eyes and ears, The level of burn is 35-9% and grade 2 in the body based on the doctor's diagnosis
Intervention groups
play animation In the first intervention group, the audio tracks of the Ministry of Culture and Guidance for children, in the second intervention group, non-intervention in control group
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N4
Registration date:2019-01-27, 1397/11/07
Registration timing:registered_while_recruiting
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
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
2019-01-05, 1397/10/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Vision and Auditory Distractions on Physiologic Indicators and Pain of Dressing change in 6-12 Years Old Children at the Burn Center of Besat Hospital, 1397-98.
Public title
the Effect of Vision and Auditory Distractions on Physiologic Indicators and Pain of Dressing change in 6-12 Years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The level of burn is 35-9% and grade 2 in the body based on the doctor's diagnosis
Age 6-12 Years Old
Exclusion criteria:
burns in the eyes and ears
speech impairment and mental retardation
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling from patients' files and then randomized block assignment in a 3 groups clinical trial control, auditory distraction and visual distraction.
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
Ethics committee ofhamadan University of Medical Sciences
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6561058582
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.UMSHA.REC.1397.565
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
pain
Timepoint
during change dressing
Method of measurement
oucher
2
Description
Physiologic Indicators
Timepoint
during dressing change
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: Vision Distraction during dressing change with animation play
Category
Treatment - Other
2
Description
Intervention group: Auditory Distractions with music play during dressing change
Category
Treatment - Other
3
Description
Control group: Non intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, Burnig Ward
Full name of responsible person
Pegah Sharifiyan
Street address
Hamadan Besta Hospital
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3252 0683
Email
rsharifian7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashiriyan
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3252 0683
Email
s.bashirian@yahoo.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
Pediatric Nursing
Street address
Sُhahid Fahmideh Bulvard
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
Dr Fatemeh Cheraghi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3252 0355
Email
f.cheraghi@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
Nursery
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6561065810
Phone
+98 81 3252 0355
Email
arash5920@yahoo.com
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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available