Protocol summary
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Study aim
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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
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Design
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The study was a randomised clinical trial with a sample size of 70 and two groups included intervention and control groups.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1.Not having bed sore
2.Not having allergy to pistacia atlantica oil
3.Norton score less than 16
4.Not having wavy mattress
5.Not having foley catheter
6.Not having skin problems in the study area
7.Over 18 years old 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.
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Intervention groups
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The aim of 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.
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Main outcome variables
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Bed sore
General information
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Reason for update
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Change the latin title of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200116046156N1
Registration date:
2020-05-31, 1399/03/11
Registration timing:
retrospective
Last update:
2021-11-16, 1400/08/25
Update count:
1
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Registration date
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2020-05-31, 1399/03/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-05, 1398/02/15
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Expected recruitment end date
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2019-07-06, 1398/04/15
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Actual recruitment start date
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2019-05-16, 1398/02/26
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Actual recruitment end date
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2019-07-24, 1398/05/02
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Trial completion date
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2019-07-24, 1398/05/02
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Scientific title
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: Evaluation of the local impact of Pistacia Atlantica oil on the prevention of bedsores
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Public title
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: Evaluation of the local impact of Pistacia Atlantica oil on the prevention of bedsores
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Not having bed sore
Not having allergy to pistacia atlantica oil
Norton score less than 16
Not using wavy mattress
Not having foley catheter
Not having skin problems in the study area
Over 18 years old of age
Exclusion criteria:
Having bed sore
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
61
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A group of patients randomised into experimental group and control group by using simple randomization method. These groups were followed up for the variables/outcomes of interest. Based on the study sample size and using random assignment table, 70 codes were assigned to patients (Randomized Allocation). Then the codes were randomly assigned to one of the experimental and control groups. The phrase oil was considered for the experimental group and the phrase control for the control group. After the hospital admission, the patient with inclusion criteria was assigned to the experimental or control group according to the order of the randomized codes.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-12, 1398/02/22
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Ethics committee reference number
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IR.HUMS.REC.1398.032
Health conditions studied
1
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Description of health condition studied
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Bed sore
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Decubitus ulcer incidence rate
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Timepoint
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Incidence of decubitus ulcer during the intervention
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Method of measurement
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Decubitus ulcer checklist
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: The control group received routine treatment for 10 days. Routine treatment consisted of changing patients' positions every two hours.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Hormozgan University Of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The collected data will be presented in SPSS file. Also the study checklist data will be presented. due to ethical reasons the patients names not included in the checklist. other data is recorded.
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When the data will become available and for how long
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Start of access period is 2 months after printing results
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To whom data/document is available
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The data will be available for health care researchers.
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Under which criteria data/document could be used
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It will be used for research and educational purposes.
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From where data/document is obtainable
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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:moslemsanjari65@yahoo.com
phone: 0098 9132490848
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What processes are involved for a request to access data/document
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The applicant can submit a demand by email or telephone and receive the information in less than 10 days following the due process.
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Comments
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