Effects of Aloe vera Gel on healing pain and itching caused by burn wound
Design
Double blind clinical trial with parallel groups, who were selected in simple randomized method using table of random numbers. Final sample size was 34 patients.
Settings and conduct
After obtaining permission from research deputy and ethics committee, the study will be conducted in burn units of Sina Medical Education Center. The patients are selected and the treatment objectives and types are introduced. The patients will be unaware of which substance will be used on which region of the body. The wounds will be washed and routine care will be conducted in control group and Aloe vera Gel will be used in intervention group. Heal is measured daily with Bets Jensen inventory and pain and itching are measured 30 minutes before and after bandage during the day and using visual scale (VAS) at night , then the results will be compared for the days 1,3,5,7,9,11,14. Statistical analyzer will proceed on the data analysis without having knowledge of intervention type.
Participants/Inclusion and exclusion criteria
Patients with maximum 20% burning of the body surface and first degree burns without blister in the sympathetic organs with the same depth are included in the study. Patients with additional diseases, using substances other than drinking water on the burn are excluded from the study.
Intervention groups
Aloe vera Gel is used in intervention group and routine treatment method is used in control group and then they are bandaged
Main outcome variables
Healing, Pain, Itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027561N10
Registration date:2018-04-04, 1397/01/15
Registration timing:retrospective
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Mojgan Lotfi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
mlotfi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2016-03-19, 1394/12/29
Actual recruitment end date
2017-08-21, 1396/05/30
Trial completion date
empty
Scientific title
The effect of Aloe vera gel on healing, pain and itching burn wound
Public title
the effect of Aloe Vera gel on burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 20% or less burns
First degree and superficial epidermal without blister burns
patient with symmetry and same depth burns wound
Adults male and female 17-60 years old
Common language between therapist and patient for effective communication
The patients should have sufficient awareness and consciousness for cooperation
Referral to the center 2 hours, at most, after burning
Suffering burn due to unintentional
Exclusion criteria:
Electrical and chemical burning
Patients with inhalation injuries
The patient should have background disease history (renal disease, cardiovascular disease, hearing problem, diabetes mellitus, allergic skin disease, malignancy, AIDS).
The patient should have history of antis stress and cytotoxic drugs consumption.
In case of advent of every kind of unusual side effect such as allergy to Aloe vera or dissatisfaction, the patient is excluded from the study
The patient’s wound has been smeared into contaminants before patient is included in the study.
A substance other than drinking water to be used on the wound before patient is included in the study.
The patient should have history of mental illness and referral to psychiatrist
Age
From 17 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
34
More than 1 sample in each individual
Number of samples in each individual:
2
Regarding sympathetic organs such as left and right hand with burning of the same depth, degree and status, it should be noted that one of the organs is randomly placed in the control and the other one is placed in the intervention group.
Actual sample size reached:
34
More than 1 sample in each individual
Actual sample size in each individual:
2
Regarding sympathetic organs such as left and right hand with burning of the same depth, degree and status, it should be noted that one of the organs is randomly placed in the control and the other one is placed in the intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
Control and intervention groups are selected by simple random sampling and random numbers table will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the patients were explained about routine care and Aloe vera in detail, however they will be unaware of which care to be employed for which burnt organ. Moreover, the statistical analyzer will be completely unaware of what data is related to what care.
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
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2017-01-08, 1395/10/19
Ethics committee reference number
IR.TBZMED.REC.1395.1052
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
L55.0, T21
ICD-10 code description
burns and corrosions, contact with heat and hot substances
Primary outcomes
1
Description
Healing
Timepoint
Every day until the 14th day
Method of measurement
Bates-Jensen wound assessment tool
2
Description
Pain
Timepoint
Every day 30 minutes before dressing, 30 minutes after dressing and 8 nights until the 14th day
Method of measurement
Visual analogue scale (VAS)
3
Description
Itching
Timepoint
Every day 30 minutes before dressing, 30 minutes after dressing and 8 nights until the 14th day
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after washing the wound with water, the Aloe vera gel(94% concentration and 3 mm of thickness ) made in Seagull company is used and then one layer of Vaseline gauze is applied on it in order to prevent gel evaporation and it is bandaged, at last
Category
Treatment - Drugs
2
Description
In the control group, on the other hand, after washing the wound with water, the routine treatment in the unit (1% Silver sulfadiazine made in Sobhan Darou Pharmacy Company) with thickness of 3 mm is used and then the pomade surface is covered with one layer of Vaseline gauze to prevent its evaporation and finally it is bandaged.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Teaching Hospital
Full name of responsible person
maryam mahboob
Street address
Children Hospital, Sheshgelan Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
artsport2000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research، Tabriz University Of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Daneshgah Street،Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Email
Ravabetomomi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research، Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Sheikh Alipour
Position
Candidate for Ph.D Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
sheikhalipourz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan lotfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
mojgan-lotfi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Mahboob
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Children Hospital, Sheshgelan Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3380 7254
Fax
Email
Artsport@gmail.com
Web page address
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
Only the results presented by the scholar are applicable without analysis.
When the data will become available and for how long
Access time 1 months after the results are published
To whom data/document is available
All faculty members of medical science universities.
Under which criteria data/document could be used
Only the results presented by the scholar are applicable without analysis.
From where data/document is obtainable
Data are available upon receive of mail by the scholar.
Mojgan Lotfi, 00989144130632, mlotfi@tbzmed.ac.ir
Maryam Mahboob, 00989143098494, artsport2000@gmail.com
What processes are involved for a request to access data/document
The scholar will be accessible, instantly, through email and then the requested files will be sent.