Compare the effectiveness of virtual reality games and positively communicate in reducing symptoms of stress and pain during dressing change in children hospitalized with burns
In a clinical trial study will be done with aim to compare the effectiveness of virtual reality games and positively communicate in reducing symptoms of stress and pain during dressing change in children hospitalized with burns, children separately and without linking together and in different time periods are treated so the blinding will be done just for patients group. receiving their first burn dressing care procedure in this burn center and absence of underlying disease for example: Disabilities is the main inclusion criteria for this study. If a child required intravenous sedation during the procedure refuse participation, or became otherwise unable to communicate during wound care, the child was withdrawn from the study. The study population will be included all children hospitalized with burns wound in Imam Mousa Kazem Hospital. a total of 40 eligible children aged between 6 and 8 years will be selected and randomly will divided into two groups: control group (Positive Communicate) intervention group (Play group). positively communicate technique will be done in both groups but in case group, virtual reality games will be used too and Children will play during dressing change. children’s symptoms of stress and pain Intensity as the Main outcomes will be measured before and after burn dressing change procedure and before and after play intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030532886N1
Registration date:2017-04-26, 1396/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-26, 1396/02/06
Registrant information
Name
Ali Noruzi Koushali
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3472 1775
Email address
a.noruzi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2017-02-14, 1395/11/26
Expected recruitment end date
2017-10-18, 1396/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of virtual reality games and positively communicate in reducing symptoms of stress and pain during dressing change in children hospitalized with burns
Public title
The Effect of Virtual Reality Game’s on Children’s Stress Symptom and Pain Intensity during Burn Wound Care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
aged 7 to 12 years for children, receiving their first burn dressing care procedure in this burn center (the usual way), no burn with high percentages (severe burns) so that the child does not have to participate in the study (at the discretion of the physician), a lack of underlying disease, for example: Disabilities or Mental disorder, written parental consent to participate in research, older than 18 years for parents and being able to read and understand Persian.
Exclusion criteria:
a lack of Parental consent during each stage of intervention, If a child required intravenous sedation during the procedure, refuse participation, or became otherwise unable to communicate during wound care, the child was withdrawn from the study.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study Simple randomization was performed by shuffling cards.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Isfahan University of Medical Sciences, HezarJerib Ave, Azadi Sq, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2017-02-14, 1395/11/26
Ethics committee reference number
IR.MUI.REC.1395.3.954
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T29, T31
ICD-10 code description
Burns and corrosions of multiple body regions, Burns classified according to extent of body surface involved
Primary outcomes
1
Description
Stress Symptom
Timepoint
Before Burn Wound Care
Method of measurement
Iranian version of Sharrer, Ryan-Wenger Children’s Stress Symptom Scale
2
Description
Pain Intensity
Timepoint
After Burn Wound Care
Method of measurement
Wong & Backer Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:
In the intervention group, in addition to using positive communication techniques when burn dressing change, children will pay to play 30 to 45 minutes before the start of the dressing change with 3D headset Game
Category
Behavior
2
Description
control group:
In the control group will be used positive communication techniques during burn dressing change
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Mousa Kazem Hospital
Full name of responsible person
Ali Noruzi Koushali
Street address
Imam Mousa Kazem Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Univresity of Medical Sciences, Vice chancellor for research
Full name of responsible person
Reza Daryabeigi
Street address
Isfahan University of Medical Sciences, HezarJerib Ave, Azadi Sq, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
د/11/5263
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Univresity of Medical Sciences, Vice chancellor for research
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
Isfahan University of Medical Sciences
Full name of responsible person
Ali Noruzi Koushali
Position
Masters
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, HezarJerib Ave, Azadi Sq, Isfahan