Comparison of efficacy of two methods of virtual reality and multimedia system on pain and pain anxiety in burn patient during dressing change: A randomized controlled clinical trial
This study is a randomized clinical trial to compare the effects of two methods of virtual reality and multimedia system on pain and pain anxiety in burn patient during dressing change that hospitalized in Tabriz Burn Center. In this study 60 burn patients will be enrolled which will be selected by convenience sampling. Then samples will be allocated randomly to three groups: control, intervention of virtual reality and intervention of multimedia system. The virtual reality and multimedia system intervention groups will receive virtual identical images (images and sounds of a waterfall) once a day for 5 consecutive days during dressing (the third to seventh day burning). The control group will receive only routine care. Pain and pain anxiety scales before and after the intervention will complete for all groups. Finally, the results of the three groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605016834N9
Registration date:2016-07-11, 1395/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of two methods of virtual reality and multimedia system on pain and pain anxiety in burn patient during dressing change: A randomized controlled clinical trial
Public title
Comparison of efficacy of two methods of virtual reality and multimedia system on pain and pain anxiety in burn patient during dressing change: A randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are hospitalized in the burn ward of arrival; have not the history of previous burns; are in burns below 25% and second- degree; are acute phase of burn (48 to 72 hours after burn); are 18 years and older; are interested in participating in the study; are conscious and orientated; have not sight and hearing problems; are not addicted; had general health over the past month; absence of numbness in the limbs target; are not diabetic(due to lack of feeling pain). Exclusion criteria: patients who not want to continue the cooperation in the study; are transferred to another ward; have absence more than one meeting; taking pain killers or sedative without prescription; taking skin graft.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TNZMED.REC.1395.135
Health conditions studied
1
Description of health condition studied
Second-degree burn patients
ICD-10 code
T20, T25
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention, immediately after intervention 5 consecutive days (the third to seventh day burning)
Before the intervention, immediately after intervention 5 consecutive days (the third to seventh day burning)
Method of measurement
Burn Specific Pain Anxiety Scale (BSPAS)
Intervention groups
1
Description
In virtual reality group: playing images and sounds of a waterfall with a virtual reality head set, once a session on 5 consecutive days during dressing (the third to seventh day burning) will be performed. Before and after the intervention pain and pain anxiety scales will be completed.
Category
Other
2
Description
In multimedia system group: playing images and sounds of a waterfall with a LCD devices, once a session on 5 consecutive days during dressing (the third to seventh day burning) will be performed. Before and after the intervention Pain and pain anxiety scales will be completed.
Category
Other
3
Description
For the control group during the intervention is intended for routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina Hospital
Full name of responsible person
Dr. Abasad Gharedaghi
Street address
Sina Hospital, Azadi Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice- Chancellor, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Third floor, No 2 Building of Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor, Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Full name of responsible person
Dr Hossein Ebrahimi
Position
PhD in nursing education
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3475 1709
Fax
Email
Ebrahimih@tbzmed.ac.i
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Full name of responsible person
Mohammad Ghahramanpour
Position
MSc in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3231 4763
Fax
Email
Amghahramanpur@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)