Comparison of the effect Emla Cream، local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of heart Patients Receiving Enoxaparin
Comparison of the effect Emla Cream، local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of ischemic heart disease Receiving Enoxaparin
Design
randomize clinical trial Participants were randomly random allocation method is used by random computer numbers
Settings and conduct
After approval of the research project by the Research Council of the University of Medical Sciences and obtaining permission from the Ethics committee of the University of Medical Sciences, and coordination with the officials of the Shahid Beheshti Hospital, the researcher referred to Shahid Beheshti Medical Center the week and with the help of the Center staff, after expressing the research goals and ensuring patients are kept confidential and obtain informed written consent from them random allocation patients who have been admitted to the study
Participants/Inclusion and exclusion criteria
patient with ischemic heart disease receive enexaprin with physician order
Intervention groups
Method 1: 1 gram of EMLA cream. of this cream is fixed 60 minutes before injection at the injection site using the dressing retainer and after 60 minutes, the skin will be cleaned and injected method 2: 3×2×2 size of ice will apply to the injection site for 5 minutes before the injection metd 3: 2 ml of lavender oil 10% will apply for 5 minutes before injection on the injection site and after 20 minutes, the skin will be cleaned and injected. Method 4: Enoxaparin injection without intervention (subcutaneous injection of enoxaparin sodium in 10 seconds on the right or left abdomen) And these methods are separate individually for each group
Main outcome variables
The amunt of pain in the injection site and the patient's comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100829004655N9
Registration date:2018-03-25, 1397/01/05
Registration timing:prospective
Last update:2018-03-25, 1397/01/05
Update count:0
Registration date
2018-03-25, 1397/01/05
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect Emla Cream، local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of heart Patients Receiving Enoxaparin
Public title
Comparison of the effect Emla Cream، local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of heart Patients Receiving Enoxaparin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1.age between 18-85 years old
full consciousness
ability to communicate
not a severe pain in other areas
no history of prescribed Enoxaparin
no scarring and lesions at the injection site
no history of allergy to lidocaine & Prilocain
no history of allergy to Lavender
Exclusion criteria:
loss of consciousness
prescription of narcotic and non-narcotic analgesics 2 hours before injection
injection of other drug in the abdomen during the study
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is continuous The patients were randomly assigned to three intervention groups and one control group
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and researcher measurement pain and comfort are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Kashan
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.31
Health conditions studied
1
Description of health condition studied
Injection pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Injection pain
Timepoint
Immediate,5 &10 minute after injection
Method of measurement
Using the VAS scale & record severe pain intensity
2
Description
the amount Patient comfort
Timepoint
Immediate,5 &10 minute after injection
Method of measurement
visual scale of comfor& record severe comfort intensity Using the
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group :In this method 1gr Emla cream is placed on the injection site with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed
Category
Prevention
2
Description
Second intervention group: In this method, a piece of ice the size of 3*2*2 Cm is placed inside the latex gloves and is placed on the injection site 5 minute before the injection
Category
Prevention
3
Description
Third intervention group:2 ml of lavender oil 10% will apply for 5 minutes before injection on the injection site and after 20 minutes, the skin will be cleaned and injected
Category
Prevention
4
Description
Control group:Enoxaparin injection without intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
+98 31 5546 6333
Email
Taghadosi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
badry torki
Position
Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Email
taghadosi_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Badry Torki
Position
Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
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 total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
If you observe the trust and mention the source, data is available for researchers
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion