The comparison of fish oil, olive oil and honey on the prevention of bed sore in patient admitted to intensive care unit
Design
This study will be a clinical trial with a control group, randomized, with parallel and blind groups.
Settings and conduct
one hundred (100) patients admitted to intensive care unit and prone to bed sore selected by a purposive sampling and randomly will be divide into three experimental and one control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients admitted to intensive care unit and prone to bed sore, having 20-60 years old, no sensitized to fish oil, olive oil or honey. exclusion criteria: having ulcer or active infection that need to intravenous antibiotics, take medications that may cause wounds Such as immunosuppressions and corticosteroids, Transferring a patient to another health facility or patient's death.
Intervention groups
"Intervention group1: After washing the heel of the patients is prone to bed sore, it will be dressed for a week with 4 cc of fish oil and at the end of the week it will be evaluated, 2:After washing the heel of the patients is prone to bed sore, it will be dressed for a week with 4 cc of olive oil and at the end of the week it will be evaluated,3: After washing the heel of the patients is prone to bed sore, it will be dressed for a week with 5 cc of honey and at the end of the week it will be evaluated" "Control group receive routine cares will include the change position every 2 hours and use of wavy mattress". All intervention groups will also receive routine care.
Main outcome variables
ulcer intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038885N1
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Maryam Khastavaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 8884
Email address
maryam.khastavaneh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2018-12-06, 1397/09/15
Trial completion date
empty
Scientific title
The comparison of fish oil, olive oil and honey on the prevention of bed sore in patient admitted to intensive care unit
Public title
The comparison of fish oil, olive oil and honey of bed sore
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients susceptible to bed sore based on Braden scale
having 20-60 years old
Do not Sensitization to fish oil, olive oil or honey
Exclusion criteria:
having ulcer or active infection that need to intravenous antibiotic
use of drugs that may cause wounding, such as immunosuppressives and corticosteroids
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be allocated randomly by block assignment between the four groups.
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
Ethic committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR.yums.REC.1396.69
Health conditions studied
1
Description of health condition studied
pressure ulcer
ICD-10 code
L89.600
ICD-10 code description
Pressure ulcer of unspecified heel, unstageable
Primary outcomes
1
Description
ulcer intensity of heel based on Braden scale
Timepoint
severe heel ulcer is evaluated before the intervention and one week after the end of the intervention. The duration of the intervention is one week.
Method of measurement
Braden Grading Scale
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group1: After washing the heel of the patients is prone to bed sore,Once a day, it will be dressed for a week with 4 cc of standard fish oil and at the end of the week it will be evaluated (Cooperative company producing powder and oil of Babolsar, Mazandaran province, Babolsar city).
Category
Prevention
2
Description
Intervention group 2:After washing the heel of the patients is prone to bed sore,Once a day, it will be dressed for a week with 4 cc of standard olive oil and at the end of the week it will be evaluated (Loya Iran Co., Gilan, Roodbar
Category
Prevention
3
Description
Intervention group3: After washing the heel of the patients is prone to bed sore,Once a day, it will be dressed for a week with 5 cc of honey and at the end of the week it will be evaluated (Standard honey from Shahd Golha Co., Mashhad, Imam Reza Street, facing Mashhad Hotel) "
Category
Prevention
4
Description
Control group: Control group receive routine cares will include the change position every 2 hours and use of wavy mattress. All intervention groups will also receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital in Yasuj
Full name of responsible person
Mohammad Behnammoghadam
Street address
Bagherkhan street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
mbehnam1363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. َAli Mosavizadeh
Street address
Shahid Motahari Blvd., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
Health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Master of Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
mbehnammoghadam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Master of Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
mbehnammoghadam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Master of Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
mbehnammoghadam@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
After conducting a clinical trial and identifying the results, We will decide to publish.