Comparison of the effect of olive oil and sesame oil in the prevention of pressure ulcers
Design
Clinical trial without control group, with parallel groups, triple blind, randomized, phase 2 on 60 patients, the random function of Excel software was used for randomization.
Settings and conduct
The place of study: The intensive care unit (ICU) was from Amir Al-Momenin; Valiasr; hospitals in Arak; Type of blinding: Three blind; How to blind: Use of stained glass and odorless oils
Participants/Inclusion and exclusion criteria
Inclusion criteria :
;Willingness to participate in research
;Age over 18 years and under 65 years
;Braden score below 14
;Probability of continuing hospitalization in the ICU
;Less than 24 hours have passed since their admission to the ICU and they have not been admitted to another ward before
;Having a systolic blood pressure of 10 mm Hg and above
;Have a hemoglobin of 12 or higher
Criteria for not entering:
;Having skin diseases
;Having pressure sores on admission
;Systemic diseases such as diabetes, bleeding from the site of injury, heart failure, kidney failure and advanced stage cancer
;Receiving vasoactive drugs
;Having a fever (body temperature above 38.8)
Intervention groups
Intervention group 1(NA):
In this group, the consumption of olive oil on the pressurized areas that have been previously examined by Braden score and have a result below 14 is rubbed and the progress of the lesion is evaluated.
Intervention group 2 (SA):
In this group, sesame oil is rubbed on the pressure areas that have been previously examined with the Braden score and the lesion is under 14 and the progression of the lesion is evaluated and the increase in pressure and its speed of healing is compared with the intervention group 1.
Main outcome variables
pressure ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220110053683N1
Registration date:2022-04-05, 1401/01/16
Registration timing:prospective
Last update:2022-04-05, 1401/01/16
Update count:0
Registration date
2022-04-05, 1401/01/16
Registrant information
Name
Parsa Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3631 3922
Email address
parsawe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of olive oil and sesame oil on the prevention of pressure ulcers in ICU patients.
Public title
Comparison of the effect of olive oil and sesame oil on prevention of pressure ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Age over 18 years and under 65 years
Patients who are at moderate to severe risk of bed sores and score less than 14 according to the nurse's diagnosis and based on the scaling of the removal tool
Probability of continuing hospitalization in the ICU
Less than 24 hours have passed since their admission to the ICU and they have not been admitted to another ward before
Having a systolic blood pressure of 10 mm Hg and above
Have a hemoglobin of 12 or higher.
Exclusion criteria:
have Skin diseases (such as psoriasis, fungal infections, fleas and ticks)
Having a pressure sore at the time of admission
Systemic diseases such as diabetes, bleeding from the site of injury, heart failure, kidney failure and advanced stage cancer
Receiving vasoactive drugs
Having a fever (body temperature above 38.8)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In simple random sampling, each element of the target community has an equal chance of being selected.
In this method, the required persons or objects are randomly selected from the list of statistical population that has been numbered and prepared for this purpose.
In our study, the random number table method will be used and we will move from right to left horizontally. We will place odd numbers in intervention group 1 and even numbers in intervention group 2, then start by entering each of the samples with the conditions for inclusion in the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the nurse - the person analyzing the statistical data - the patient himself will be blinded.
To blind the nurse, two groups of glass containers (a - b) of the same color are used for which olive and sesame oil are inseparable. Also, sesame and odorless olive oil made by Barij Essential Oil Company are used.
To blind the person analyzing the statistical data, the information of the two groups with the symbols A and B, without mentioning which type of oil was used in each group, will be provided to the statistical data analyzer.
In order to blind patients, the necessary explanations will be given at the beginning of the research (In this research, two types of oils are used and you will be randomly placed in one of these two groups without knowing it).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
second partition, second floor , Vice Chancellor for Research and Technology، Arak University of Medical Sciences and Health Services, Payambar Azam (PBUH) University Complex, around Dr. Mehdi Charm Dooz Square, Dr. Mohammad Gharib Blvd, Sardasht region, Arak, Markazi
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.ARAKMU.REC.1400.341
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Prevention of pressure ulcers
Timepoint
at the start of reasrch and day 3 - 7
Method of measurement
Braden score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some sesame oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer.
Category
Prevention
2
Description
Intervention group 2: Admission will be assessed with Braden instrument, and those with a score below 14 who are at moderate to severe risk of bed sore will be included in the study. Then, on a daily basis, pressure ulcer prevention methods, such as changing position at least every two hours, using small pillows between the legs or heels to remove and reduce pressure, controlling urinary incontinence, and using absorbent pads and cleansing the skin Infection) is routinely performed for patients. The researcher first tests some olive oil on the inner area of the forearm and if there is no allergic reaction, in the next steps twice a day (9-21 hours), 2-3 cc on pressure points (hip, sacrum, heel) is rubbed and allowed 1-2 minutes to absorb for 7 days. Then the sacrum’ hip and heel of both groups of patients will be assessed on days 3 and 7 (based on previous studies as a cut point) in terms of incidence of pressure ulcer.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Parsa Ahmadi
Street address
No. 54.Tobacco Town-University Town - Saqez -Kurdistan Province
City
arak
Province
Markazi
Postal code
6681473677
Phone
+98 918 212 1359
Email
parsawe@gmail.com
2
Recruitment center
Name of recruitment center
amir AL momenin hospital
Full name of responsible person
Parsa Ahmadi
Street address
No. 54.Tobacco Town-University Town - Saqez -Kurdistan Province
City
arak
Province
Markazi
Postal code
6681473677
Phone
+98 918 212 1359
Email
parsawe@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
second floor , Vice Chancellor for Research and Technology، Arak University of Medical Sciences and Health Services, Payambar Azam (PBUH) University Complex, around Dr. Mehdi charm Dooz Square, Dr. Mohammad Gharib Blvd, Sardasht region ، Arak city , Markazi province.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.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 and Technology of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Parsa Ahmadi
Position
nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
No. 54, Dokhaniat town, Daneshgah town, Saqqez
City
Arak
Province
Markazi
Postal code
6681473677
Phone
+98 87 3631 3922
Email
parsawe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
fatemeh mehrabi
Position
Faculty member of Arak University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Complex of the Great Prophet. sardasht . Arak
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3505
Email
fmehrabi1392@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 54, Dokhaniat town, Daneshgah town, Saqqez
City
Arak
Province
Markazi
Postal code
6681473677
Phone
+98 86 3631 3922
Fax
Email
Parsawe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available