The effect use of olive oil and bitter almond oil on Areas under pressure of the skin، on predicting the symptoms of compression ulcers in ICU (Hospitals of Kerman University of Medical Sciences in 2018
Design
A clinical trial, the research community is patients admitted to special sectors of hospitals affiliated to Kerman University of Medical Sciences. The research sample is 96 patients divided in to three groups In the form of randomized blocks
Settings and conduct
The researcher is referring to the in hospitals of Kerman University of Medical Sciences. Available samples are selected according to inclusion and exclusion criteria, and they are randomly assigned to 3 groups. After selecting the samples, the demographic information questionnaire and the selected patients will be monitored every 24 hours for 2 weeks.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Having a Foley catheter،Having a Norton benchmark less than 16
Exit criteria:
Dissatisfaction with Ghayumin،Observe any skin symptoms Having skin problems،The presence of allergens to bitter Almond and olive oil، Having a compression ulcer،Having diabetes
Intervention groups
In the First intervention group: of Olive oil ، In addition to the usual treatments for the section's implementation used.In the Second intervention group: of bitter almond oil ، In addition to the usual treatments for the section's implementation used.
Main outcome variables
Pressure ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160914029817N8
Registration date:2018-12-29, 1397/10/08
Registration timing:prospective
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-14, 1397/11/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Bitter almonds and Olive oil on the prevention of pressure ulcers in intensive Care units Pationt
Public title
Investigating the effect of Olive and Bitter almonds on pressure ulcers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Norton Criterion is less or equal 16
Having a Foley catheter
Exclusion criteria:
Dissatisfaction with Ghayumin
having diabetes
Having a pressure ulcer
Observe any skin symptoms caused by drug allergy (rash, hives, redness, swelling).
Having skin problems
The presence of allergens to bitter bitter olives and their products
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomize، The subjects are randomly assigned into three groups using software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study do not know which oils are used on their skin.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of kerman University of Medical Sciences
Street address
University of Medical Sciences, Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.KMU.REC.1397.314
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89.1
ICD-10 code description
Stage II decubitus ulcer
Primary outcomes
1
Description
Create a pressure ulcer
Timepoint
Evaluation of pressure ulcers at the beginning of the study and Two weeks after the intervention
Method of measurement
Grading system for the substrate wound panel
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: Use of Olive oil from a reliable exir factory, which has been standardized on this product under laboratory conditions. This product has the standard code and Apple health mark of Iranian Food and Drug Administration and the register number is 10124.39، In addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours. Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made
Category
Prevention
2
Description
Intervention group: Second intervention group: Use of bitter almond oil from a reliable factory of natural extract of Nowshad brand that has been prepared according to the standards approved by the Food and Drug Administration of Iran and has the and Apple health mark of Iranian Food and Drug Administration and the register number is 1228208485، In addition to the usual treatments for the section's implementation that basically change the situation every two hours once and use the Wavy mat. Intervene in both groups for 2 weeks every 24 hours. Sacrum, Batex and Sacred Squares: 1 cc, Heels: 0/5cc, Batex:1/5cc Will Be Made.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Shohreh Saljoghiyan
Street address
Shafa Medical Education Center، Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Fax
Email
shafahospital@kmu.ac.ir
Web page address
htt://sh.kmu.ac.ir
2
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Shohreh Saljoghiyan
Street address
Imam Khomeini highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
Email
afzalih@kmu.ac.ir
Web page address
htt://kmu.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Shohreh Saljoghiyan
Street address
Gharani St, Valiasr intersection,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas pardakhty
Street address
Research Management, Deputy of research and technology, Ibn Sina St., Tahmasebad Square, Kerman
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 5583
Email
abpardakhty@kmu.ac.ir
Web page address
htt://vcrt.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Shohreh Saljoghiyan
Position
Master of Internal Surgery Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, beginning of the Haft Bagh Alavi Highway , Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 32119021
Email
s.saljoghiyan1985@gmail.com
Web page address
http://kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Smat nohi
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi Nursing and Midwifery Faculty، University of Medical Sciences،beginning of the Haft BaghAlavi High way، Kermann
City
Kerman
Province
Kerman
Postal code
7616931555
Phone
+98 34 3132 5220
Fax
Email
e_nuhi@kmu.ac.ir
Web page address
htpp://kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shohreh Saljoghiyan
Position
Master of Medical Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Nursing and Midwifery Faculty،beginning of the Haft Bagh Alavi، Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 9021
Email
s.saljoghiyan1985@gmail.com
Web page address
htt://kmu.ac.ir
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