Reducing the pain caused by dressing in burn patients, reducing the anxiety of dressing in burn patients, reducing hospitalization time and costs for burn patients.
Design
The clinical trial, community-based, include control group, with parallel groups, randomized
Settings and conduct
This randomized clinical trial was conducted on 60 patients aged 18-60 years old admitted to the burn ward of Shahid Rajaee Hospital in Qazvin
Participants/Inclusion and exclusion criteria
Patients entered the study who were undergoing graft surgery; have the ability to speak; dressed in the usual dressing method; do not haveknown psychological disorders in the past or present; their graft should not be located in the head and neck; do not have neurological disorders and anesthesia in burn limb; do not have severe hearing or visual problems. People who did not have any entry requirements were not included in the study.
Intervention groups
In the intervention group the day after the graft, anesthetic anxiety burning questionnaire was completed and then the dressing would be opened by the researcher. The visual analogue pain questionnaire will be completed during dressing. In both groups, 5 mg of morphine was sacrificed half an hour before changing muscle dressing Will be injected. In the control group, the dressings will be opened and replaced by the researcher three days after the grafting. In the control group, the anxiety inventory of the burn pain will be completed before dressing and the visual pain test during the dressing.
Main outcome variables
Pain; anxiety; time of hospitalization; costs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180926041141N1
Registration date:2018-10-24, 1397/08/02
Registration timing:registered_while_recruiting
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
abbas ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 1571
Email address
a.ahmadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Early Replacement of Skin graft Dressing on Pain and Anxiety in Burn Patients
Public title
The effect of early replacement of the skin graft dressing in the burn
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient can speak
Dress with an usual method
Not having known mental disorders
Not having neurological disorders and anesthesia in burned limb
Not having severe hearing or visual problems
Exclusion criteria:
The patient can not speak
Dress with an unusual method
Known mental or psychiatric disorders
graft on the head and neck
Neurological disorder in burnt limb
Severe hearing impairment or visual problem
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
The first specimen was stacked and randomly placed in one of the groups. Subsequently, the other specimens were placed in each group by minimization.
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 of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2017-12-14, 1396/09/23
Ethics committee reference number
IR.QUMS.REC.1396.341
Health conditions studied
1
Description of health condition studied
diseases of skin and subcotaneus
ICD-10 code
اختلال در
ICD-10 code description
اختلال در پوست و بافت زیرجلدی
Primary outcomes
1
Description
Pain score in visual pain scale
Timepoint
Measuring pain one and three days after skin graft
Method of measurement
visual pain scale
2
Description
Anxiety scores in Burn specific pain anxiety scale
Timepoint
Measuring Anxiety of pain one and three days after skin graft
Method of measurement
Burn specific pain anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, dressing will be done 24 hours after skin grafting
Category
Prevention
2
Description
In the control group, the dressing of the skin graft will be done three days after skin grafting
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Hospitalبیمارستان شهید رجایی
Full name of responsible person
Abbas Ahmadi
Street address
Rajaie Hospita, Qarani ave., Padegan street
City
Qazvin
Province
Qazvin
Postal code
4313996134
Phone
+98 28 3333 5800
Fax
+98 28 3332 0105
Email
hosrajaee@qums.ac.ir
Web page address
http://hosrajaee.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Peymani Amir
Street address
Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3333 6001
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
10
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
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Ahmadi
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
rajaie hospital-qarani ave.padegan ave
City
qaznin
Province
Qazvin
Postal code
4313996134
Phone
+98 28 3333 5800
Fax
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir
Web page address
http://hosrajaee.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yeke Fallah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Shahid Bahonar Blvd, Qazvin, Iran
City
qazvin
Province
Qazvin
Postal code
371995315
Phone
+98 28 3333 6001
Fax
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Ahmadi
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaie hospital, Qarani ave., Padegan ave.
City
Qazvin
Province
Qazvin
Postal code
4313996134
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir
Web page address
http://hosrajaee.qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable individual data is available to publishers
When the data will become available and for how long
One year
To whom data/document is available
Researchers working in collegiate
academia and scientific
academia
Under which criteria data/document could be used
Any required scientific analysis is allowed
From where data/document is obtainable
abbasahmadi54321@gmail.com
What processes are involved for a request to access data/document
The purpose and application of the requested information is to be sent to the e-mail address