Protocol summary

Study aim
Determination of the effect of olive oil and sweet almond oil on the prevention of bed sore
Design
A randomized clinical trial study was conducted in three groups (control and two test groups), with parallel, double blind, randomized groups
Settings and conduct
The sample size will be 90 patients whom randomly assigned to three groups ( two intervention groups and one control group). Given that sweet almond oil and olive oil are odorless, but they are somewhat different in terms of concentration and color Therefore, researcher blindness and researcher assistance will not be possible However, in the case of research samples and the person analyzing the data, blinding information will be applied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients without bed ulcer; exclusion criteria: Patient dissatisfaction with collaboration in the research.
Intervention groups
The method of intervention will be: every day, 1-3 ml of olive oil (first intervention group) or sweet almonds (second intervention group) we used in order for gently massage in the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. The control group too, received the nursing care like change position every 2 hours, and using wavy mattress (routine nursing care in the ward). the incidence of bed sore and its grades will be investigated within one week after using these two oils.
Main outcome variables
The primary outcome is the percentage of people with bed sores.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170124032147N4
Registration date: 2018-05-14, 1397/02/24
Registration timing: retrospective

Last update: 2018-05-14, 1397/02/24
Update count: 0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Bahareh Ghafourzadeh Toomatari
Name of organization / entity
Tehran university of medical scienc, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
b-ghafourzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Massage of Olive Oil and Sweet Almond on prevention of Bed Sore in Hospitalized Patients
Public title
The Effect of Olive Oil and Sweet Almonds on the prevention of Bed Sore
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients without Bed Sore Inability to movement or to move only with an instrument
Exclusion criteria:
The possibility of any susceptibility to the use of Olive Oil or SweetAlmond oil Patient dissatisfaction with collaboration in the research
Age
From 42 years old to 93 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples were randomly assigned to the six-block questionnaire, which were performed by the software. Sixth permutations were determined using the three letters A for the control group, the letter B for the intervention group with olive oil and the letter C for the intervention group with sweet almond oil, and using the randomized method, six permutations in the triple groups were chosen.
Blinding (investigator's opinion)
Double blinded
Blinding description
It should be noted that sweet almonds and olive oil were odorless, but they have differences in their concentration and color, so blindness of researcher impossible.but these oils were placed in the dark bottle, so the patients were blindness. In this study double blindness (patients and analyzer the data ) were take place.
Placebo
Not used
Assignment
Parallel
Other design features
To Randomize the method of enclosed envelopes used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
(Nusrat East) Dr Mirkhani Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2687

Health conditions studied

1

Description of health condition studied
Bed sore
ICD-10 code
L89.9
ICD-10 code description
Pressure ulcer of unspecified site

Primary outcomes

1

Description
The percentage of people with bed sore in Braden questionnaire
Timepoint
Before the intervention begins, every 24 hours for one week, immediately after the intervention
Method of measurement
Braden International Standard (Standard Instrument)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: The method of intervention were done as: every day, 1-3 ml of olive oil ( was made by Exir company) we used in order for gently massage in the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change position every 2 hours, and using wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil.
Category
Prevention

2

Description
Second intervention group: The method of intervention were done as: every day, 1-3 ml of sweet almond oil (was made by Barij essence) we used in order for gently massage in the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change position every 2 hours, and using wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil.
Category
Prevention

3

Description
control group: The control group, just giving the routine treatment such as, change position every 2 hours, and using wavy mattress. Then, the incidence of bed sore and its grades will be investigated within one week.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Jafar Sadeq hospital (AS)
Full name of responsible person
Zainab Islami Hassan Abadi
Street address
Imam Jafar Sadeq hospital (AS), Square Veteran, Basij Boulevard
City
Maybe
Province
Yazd
Postal code
8961977138
Phone
+98 35 3235 1200
Email
ali.rahimy67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Massoud Younesian
Street address
Beginning of Ghods Ave., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 35 3232 9608
Email
ali.rahimy67@gmail.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Faculty of Nursing and Midwifery Medical Sciences of Tehran
Full name of responsible person
Zainab Islami Hassan Abadi
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
(Nusrat East) Dr. Mirmohani Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 35 3232 9608
Fax
Email
b-ghafourzadeh@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Tehran University of Medical Sciences
Full name of responsible person
Zainab Islami Hassan Abadi
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
(Nusrat East) Dr. Mirmohani Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 35 3232 9608
Fax
Email
b-ghafourzadeh@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zainab Islami Hassan Abadi
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
(Nusrat East) Dr. Mirmohani Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 35 3232 9608
Fax
Email
b-ghafourzadeh@razi.tums.ac.ir
Web page address

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
No more information.
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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