Objectives are: to determine the effect of topical Olive oil on prevention of bed sore; to determine the frequency distribution of
bedsore; to determine the mean duration of not developing bedsores; to determine demographic characteristics associated with bedsore. Design: this research is an experimental study of the randomized clinical trial with control group. Setting and conduct: The control group is received skin care
includes changing positions every 2 hours and floating mattress (the standard treatment that in all centers are only included this) and the intervention group in addition to standard therapy, receive topical Olive oil. Participants: 60 eligible patients were randomly selected and with main inclusion criteria: having 18 years of age and older; lack of bedsores and the main exclusion criteria: the incidence of any sensitivity due to using of Olive oil be in two groups. Intervention: Famila labeled virgin Olive oil with Standard sign has been prepared, which once a day and each time 15 cc of it is gently and without massage applied on under pressure areas of the body. Selected patients receive topical Olive oil for three weeks and every 24 hours the skin care area is evaluated by the investigator and occurrence or non-occurrence of bedsores grade 1-4 in these areas is recorded in questionnaire. It also is stipulated that the two groups do not use any creams or other oil on the area. Main outcome variables: bedsore; applying topical Olive oil; duration of lack of developing bedsores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111014634N2
Registration date:2014-02-20, 1392/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Zahra Abbas Ali Madadi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1367 6284
Email address
zabbasalimadadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical Olive oil on prevention of bedsore in ICU patients at educational -medical hospitals of Qazvin .
Public title
Effect of topical Olive oil on prevention of bedsore in intensive care unit patients
Purpose
Prevention
Inclusion/Exclusion criteria
Major inclusion criteria: having 18-90 years old; lack of skin problems;
lack of bedsores; no history of diabetes; no history of sensitivity to the Olive and Olive products; having a Foley catheter.
Major exclusion criteria: the incidence of any sensitivity due to using of Olive oil; lack of consent of guardians and sample to continue to participate in the study; transferring the patient to another center outside the city of Qazvin; the patient dies; observing any Sign of skin problems (rash, hives, redness, swelling, ulcers).
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2012-12-05, 1391/09/15
Ethics committee reference number
6643/20/د
Health conditions studied
1
Description of health condition studied
Bedsore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Bedsore
Timepoint
Once every 24 hours
Method of measurement
Skin areas is observed and evaluated by the investigator and the occurrence or non-occurrence of bedsores grade 1-4 in these areas is recorded in questionnaire.
2
Description
Applying topical Olive oil
Timepoint
Once every 24 hours
Method of measurement
Based on yes or no is recorded in the questionnaire
3
Description
Duration of lack of developing bedsore
Timepoint
Once every 24 hours
Method of measurement
Based on day is recorded in the questionnaire
4
Description
Age
Timepoint
First meeting of evaluation
Method of measurement
Based on year is recorded in the questionnaire
5
Description
Sex
Timepoint
First meeting of evaluation
Method of measurement
Based on sex is recorded in the questionnaire
6
Description
Weight
Timepoint
First meeting of evaluation
Method of measurement
Based on Kilogram is recorded in the questionnaire
7
Description
Amount of mobility
Timepoint
Once every 24 hours
Method of measurement
Based on Braden scale is recorded in the questionnaire
8
Description
Defecation control
Timepoint
Once every 24 hours
Method of measurement
Based on yes or no is recorded in the questionnaire
9
Description
Position of head of bed
Timepoint
Once every 24 hours
Method of measurement
Based on degree is recorded in the questionnaire
10
Description
Height
Timepoint
Once every 24 hours
Method of measurement
Based on Meter and Centimeter is recorded in the questionnaire
11
Description
Taking Carbamazepine, Co-trimoxazole and Largactil
Timepoint
Once every 24 hours
Method of measurement
Based on yes or no is recorded in the questionnaire
Secondary outcomes
1
Description
Duration of ICU hospitalization
Timepoint
Once at the end of ICU hospitalization
Method of measurement
Based on day is recorded in the questionnaire
Intervention groups
1
Description
The control group is received skin care
includes changing position every 2 hours and floating mattress (the standard treatment that in all centers are only included this).
Category
Prevention
2
Description
The intervention group in addition to changing positions every 2 hours and floating mattress (standard therapy), receive topical Olive oil. Famila labeled virgin Olive oil with Standard sign has been prepared, which once a day and each time 15 cc of it is gently and without massage applied on Pinna, Shoulders, Spine, Waist, Buttocks, Iliacs and Sacrum, Elbows, Heels and Ankles areas. Selected patients receive topical Olive oil for three weeks and every 24 hours the skin care area is observed and evaluated by the investigator and occurrence or non-occurrence of bedsores grade 1-4 in these areas is recorded in questionnaire.It also is stipulated that the two groups do not use any creams or other oil on the area. Meanwhile, the two groups is matched by age and sex.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU sections of educational - medical hospitals of Qazvin
Full name of responsible person
Zahra Abbas Ali Madadi master student of intensive care nursing
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Zeinab Jourabchi
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
28/6/7309
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Abbas Ali Madadi
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 1367 6284
Fax
+98 28 1223 7268
Email
madadi_z20@yahoo.com
Web page address
www.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Reza Zeighami
Position
PHD
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 1333 8127
Fax
+98 28 1223 7268
Email
behsare@yahoo.com
Web page address
www.qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Abbas Ali Madadi
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 1367 6284
Fax
+98 28 1223 7268
Email
madadi_z20@yahoo.com
Web page address
www.qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)