Comparative investigating of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized in units of Aliebn-abitaleb Hospital, Rafsanjan 2019
determination of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized
Design
controlled clinical trial with a parallel group design of 120 patients.triple blinded, randomized.
Settings and conduct
In this study 120 patients admitted to Ali Ibn Abi Talib Hospital wards of Rafsanjan will be selected based on inclusion criteria and will be divided into four groups (Aloe Vera-placebo, Olive-placebo, Olive-Aloe Vera and control group).. The selected patients will receive Aloe Vera gum, topical olive oil and two placebo for one week, and each 24 hours of skin care will be checked by the evaluator and the presence or absence of grade 1 to 4 ulcers in these areas will be recorded on the checklist. .
Participants/Inclusion and exclusion criteria
The inclusion criteria :
1- Inclination to participate in research
2. Age over 18 years
3. Braden score less than 14
4. Lack of diabetes
5. Lack of skin diseases
6. Lack of pressure ulcer beforehand
7. Having a systolic blood pressure of 10 mm Hg and above
8. Not having fever (Body temperature higher than 38/8)
9. Hemoglobin higher than 12 mg / dl
10. No history of allergy to olive oil and aloe vera gel and their products
Exit criteria:
1- Not willing to continue participating in the study
2. Reduced hemoglobin levels
3. Reduced blood pressure to less than 100 mmHg
4. Hyperthermia during the study
5- Sensitization to olive oil, Aloe vera gel, placebo and any other medicine.
6. Transferring the patient to another center
7- Increase Braden Score to over 14
8. death
Intervention groups
Based on the inclusion criteria, 120 people are selected and divided into four groups. Of these, three groups A, B.C are recipients of substances, placebo and routine care, and D group as a control group only receives routine care.
Main outcome variables
Incidence of pressure ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N20
Registration date:2019-10-11, 1398/07/19
Registration timing:registered_while_recruiting
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigating of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized in units of Aliebn-abitaleb Hospital, Rafsanjan 2019
Public title
Comparative investigating of the Effect of Aloe Vera gel and Olive Oil on Incidence of pressure ulcer in patients Hospitalized
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in research
Age over 18 years
Braden score less than 14
Lack of diabetes
Lack of skin diseases (such as psoriasis, fungal disease)
Lack of pressure ulcer beforehand
Having a systolic blood pressure of 10 mm Hg and above
Not having fever (Body temperature higher than 38/8)
Hemoglobin higher than 12 mg / dl
No history of allergy to olive oil and aloe vera gel and their products
Exclusion criteria:
Not willing to continue participating in the study
Reduced hemoglobin levels during the study to less than 12 mg / dL in men and less than 10 in women
Reduced blood pressure to less than 100 mmHg
Hyperthermia (temperature higher than 38.8) during the study
Sensitization to olive oil, Aloe vera gel, placebo and any other medicine.
Transferring the patient to another care center
Increase Braden Score to over 14
Patient's death
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the Braden criterion, people with a moderate and severe risk of pressure ulcer are identified.then, 120 people are selected for entry criteria. Subsequently, according to the random block method, people are divided into four groups of 30 with titles A, B, C, D. A {Aloe vera-Placebo group}
B {olive oil - placebo group }
C {Olive Oil - Aloe Vera group }
D {control group}
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the outcome assessor and the Data analyer are not aware of the type of substance used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blv, Central Organization of the Central Organization of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2019-03-15, 1397/12/24
Ethics committee reference number
IR.RUMS.REC.1397.261
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Incidence or absence of pressure ulcers
Timepoint
Evaluate skin samples after using the ingredients every 24 hours for seven days
Method of measurement
check list of pressure ulcer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Each person in this group receives an Aloe vera gel on one side of his sacrum and iliac, and on the other side he receives a placebo (a lubricant gel) at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.
Category
Prevention
2
Description
Intervention group: intervention group B: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives a placebo (glycerin oil) at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.
Category
Prevention
3
Description
Intervention group C: Each person in this group receives olive oil on one side of his sacrum and his iliac, and on the other side he receives Aloe Vera gel at 5 cc twice a day for seven days.in addition to he receives Routine care, involves changing the patient's position every 2 hours and using wavy mattresses.
Category
Prevention
4
Description
Control group: Group D: No intervention other than routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliebnabitaleb hospital of Rafsanjan
Full name of responsible person
Najmeh Ghasemirad
Street address
Jomhory street, Parastar blv
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
ghasemirad610@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayyebeh Mirzaei
Street address
Emam ali bulvarde
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3452 5900
Email
t.mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Email
t.mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
+98 34 3428 0071
Email
t.mirzaei@rums.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