Determination of local effect of pistacia atlantica oil on prevention of bed sore in hospitalized patients in Shahid Mohammadi hospital of Bandar Abbas in 2019
Design
The study was a randomised clinical trial with a sample size of 70 and two groups included intervention and control groups.
Settings and conduct
This study was performed in internal wards of Shahid Mohammadi hospital in Bandar Abbas. Patients were randomly divided into two groups. In the control group, only routine treatment, (changing the patients' position every two hours) was used. In the intervention group, in addition to changing position, 5 cc of this oil was applied locally in the sacrum area for 10 days and 3 minutes daily.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- no bed sore
2- no allergy to pistacia atlantica oil
3- Norton score less than 16
4 - no wavy mats
5- no foley catheter
6- no skin problems in the study area
7- over 18 years of age
Exclusion criteria:
1- Allergy to pistacia atlantica oil.
2- Patient's or guardian's dissatisfaction with continuing cooperation.
3. Change Norton's score to more than 16 in the first week of the intervention.
4. The patient dies or is transferred to another health center within the first week of intervention.
5. Discharge in the first week of intervention.
6. The occurrence of any unforeseen factor during the intervention that impedes the continuation of the intervention.
Intervention groups
The aim of this study was evaluating the effect of local pistacia atlantica oil on prevention of bed sores. In the control group routine treatment, (changing the patients' position every two hours) was used. In the intervention group the oil was applied.
Main outcome variables
Bed sore
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200116046156N1
Registration date:2020-05-31, 1399/03/11
Registration timing:retrospective
Last update:2020-05-31, 1399/03/11
Update count:1
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Moslem Sanjari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 6088
Email address
arshadmsssanjari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
2019-05-16, 1398/02/26
Actual recruitment end date
2019-07-24, 1398/05/02
Trial completion date
2019-07-24, 1398/05/02
Scientific title
Evaluating the effect of local pistacia atlantica oil on prevention of decubitus ulcer
Public title
Evaluating the effect of local pistacia atlantica oil on prevention of decubitus ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No bed sore
Not allergy to pistacia atlantica oil
Norton score less than 16
No wavy mattress
No foley catheter
No skin problems in the study area
Age over 18 years
Exclusion criteria:
having bed sore
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple and individual randomization method was used. Based on the study sample size and using random number assignment table, 70 codes from number one to seventy were assigned to patients (Randomized Allocation). Patients were then randomly assigned to one of the intervention or control groups. The phrase oil was considered for the intervention group and the term control for the control group. Finally, after the researcher went to the hospital, the patients who had the conditions to enter the study were assigned to the intervention or control group based on the order of the random codes.using Randomized Allocation software. In the case that after the hospital admission, the patient with inclusion criteria was assigned to the intervention or control group according to the order of the randomized codes.
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 hormozgan University of Medical Sciences
Street address
Jomhori eslami Blvd, Payambare azam medical training and research complex
City
bandar abbas
Province
Hormozgan
Postal code
7916839319
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.HUMS.REC.1398.032
Health conditions studied
1
Description of health condition studied
bed sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of decubitus ulcer
Timepoint
Incidence of decubitus ulcer during the intervention
Method of measurement
decubitus ulcer checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received local pistacia atlantica oil (5 cc) in the sacrum area for 3 minutes and the patients were examined daily for ulcer. This oil was used once daily for 10 days for each patient. The oil was produced by Dr. Yousefi's Herbal Products Company and commissioned by researcher in 50cc vials.
Category
Prevention
2
Description
Control group: The control group received routine treatment for 10 days. Routine treatment consisted of changing patients' positions every two hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid mohahadi hospital
Full name of responsible person
Dr. aref faghih
Street address
Jomhori eslami Blvd, Payambare azam medical training and research complex, shahid mohamadi hospital
City
Bandar abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3334 7000
Fax
+98 76 3334 7000
Email
shmh@hums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. aref faghih
Street address
Shahid chamran Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
mail@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Moslem sanjari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
MSc Student of medical Surgical Nursing
Street address
No. 7 Ave., Esteghlal Blvd
City
Jiroft
Province
Kerman
Postal code
7871644497
Phone
+98 913 249 0848
Email
Arshadmsssanjari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. aref faghih
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Emam hosein Blvd., Hormozgan University of Medical Sciences., Faculty of nursing and medwifery.
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
0098 76 3317723
Email
aref.faghih@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Moslem sanjari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
MSc Student of medical Surgical Nursing
Street address
No. 7 Ave., Esteghlal Blvd
City
Jiroft
Province
Kerman
Postal code
7871644497
Phone
+98 913 249 0848
Email
Arshadmsssanjari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The collected data will be presented in the form of a spss file or data in the study checklist. due to ethical reasons the patients names not included in the checklist. other data is recorded.
When the data will become available and for how long
Start of access period 2 months after printing results
To whom data/document is available
The data will be available to all health care researchers.
Under which criteria data/document could be used
It will be used for research and educational purposes.
From where data/document is obtainable
Mr. Aref Faghih Assistant Professor of Nursing and Midwifery Faculty of Hormozgan University of Medical Sciences by:
Email:aref.faghih@hums.ac.ir
phone: 0098 9173641032
Mr. Moslem Sanjari Senior Student of Internal Surgery Nursing at Hormozgan University of Medical Sciences by: Email:Arshadmsssanjari@yahoo.com
phone: 0098 9132490848
What processes are involved for a request to access data/document
The applicant can submit an application by email or telephone and receive the information in less than 10 days following the due process.