Determination of the Effect of Fish Oil on Prevention of Pressure Wound in Patients Admitted to the Intensive Care Unit
Design
A randomized clinical trial with a control group, with three parallel groups
Settings and conduct
The present study will be carried out in Besat hospital of Hamedan in 1398. In this study 102 patients will be treated and controlled in the placebo group. In all three groups of patients, routine care, such as a change in position every three hours will be performed. Intervention group In addition to regular care, 2 cc of fish oil will be gently rubbed by the researcher daily in the sacrum area. In the placebo group, soybean oil will be used at the place of interest.. This study will be performed on each patient for five days, and the assessment will be evaluated on a daily basis by the National Pressure Ulcer Advisory Panel (NPUAP).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stable hemodynamic status, Having a healthy skin
Exclusion criteria: Dissatisfaction with the patient and their family to participate in the study, diabetes, drug addiction
Intervention groups
In this study 102 patients were randomly assigned into three groups of placebo, intervention and control. In all three groups of patients, routine care, such as a change in position every three hours and the use of mats, will be performed. Intervention group In addition to regular care, 2 cc of fish oil will be gently rubbed by the researcher daily in the sacrum area. In the placebo group, soybean oil(no therapeutic effect) will be used. In the control group, no special action will be taken.
Main outcome variables
Pressure ulcers grade 1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N23
Registration date:2019-04-29, 1398/02/09
Registration timing:registered_while_recruiting
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of fish oil in prevention of pressure ulcer of hospitalized patients admitted to intensive care unit.
Public title
effect of fish oil in preventing pressure ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Stable hemodynamic status
Healthy skin
Not sensitivity to seafood
Exclusion criteria:
Dissatisfaction with the patient and their family to participate in the study
Diabetes
Drug addiction
Age
From 18 years old to 85 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using 6-point permutational block method and randomization was done by computer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.UMSHA.REC.1397.776
Health conditions studied
1
Description of health condition studied
Skin integrity disorder
ICD-10 code
L98.9
ICD-10 code description
Disorder of the skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
pressure ulcer
Timepoint
Before and five days after intervention
Method of measurement
National pressure ulcer advisory panel cheklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group In addition to regular care, 2 cc of fish oil will be gently rubbed by the researcher daily in the sacrum area
Category
Prevention
2
Description
Placebo group: In the placebo group,soybean oil( without having any therapeutic effect) will be used at the skin of target area
Category
Placebo
3
Description
Control group: In the control group other than routine care, no special action will be taken.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Reza Borzou
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Hamadan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samira Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
S.Samira.Sadeghi65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instructore
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.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