Determination of the effect of syzygium and cinchona ointments on the severity of Pain Caused by enoxaparin In patients with acute coronary syndrome
Design
Randomized clinical trial with four groups and paralle
Settings and conduct
The present study is a quasi-experimental study with 140 patients in Farshchian heart hospital in Hamedan. In the first group, injections of the first day (6 am) and for the second time at 6 am, 80 mg of enoxaparin are injected without any additional intervention. The day before injection of anoxoparin from the gum The tape will be used at the 1 cm stance and will be used on the area of the dressing. After the desired time, the injection is carried out by the researcher, and the pain will be measured immediately. The third day, half an hour before the injection, Clove ointment and fourth day placebo will be used then the pain will be measured. The procedure in the second, third and fourth groups is exactly the same as in the first group, with the difference in the order of use of extracts and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI Between 25-19, Patient alertness and ability to analyze pain, The absence of uncontrolled coagulation disorders
Exclusion criteria: Infection and inflammation in the skin of the target area, Having allergies to herbal medicines
Intervention groups
Intervention: In the intervention groups, before injection of enoxaparin, syzygium and cinchona ointments will be used and the severity of the pain will be evaluated at different intervals within three days.
In the control group, no additional intervention will be performed.
Main outcome variables
Severity of pain caused by injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N21
Registration date:2019-04-17, 1398/01/28
Registration timing:registered_while_recruiting
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of syzygium and cinchona ointments on enoxaparin injection pain intensity in acute coronary syndrome
Public title
Effect of syzygium and cinchona ointments on pain intensity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
BMI Between 25-19
Patient alertness and ability to analyze pain
The absence of uncontrolled coagulation disorders
Exclusion criteria:
Having allergies to herbal medicines
Infection and inflammation in the skin of the target area
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to four groups of 35 people based on quadruple random permutation blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.UMSHA.REC.1397.655
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and after intervention
Method of measurement
Visual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : In the cinchona ointment group, half an hour before the injection of enoxaparin, the cinchona ointment will be applied to the injection site
Category
N/A
2
Description
Intervention group: In the syzygium ointment group, half an hour before the injection of enoxaparin, the syzygium ointment will be applied to the injection site.
Category
N/A
3
Description
Intervention group: In the placebo group, half an hour before the injection of enoxaparin, the placebo will be applied to the injection site
Category
N/A
4
Description
Control group: No special action will be taken
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian heart center
Full name of responsible person
Gholamhossein Falahinia
Street address
Shahid Fahmideh St., Farshchian heart center, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Falahinia@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Gholamhossein Falahinia
Position
Instructore
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Falahinia@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Gholamhossein Fallahinia
Position
Instructore
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Falahinia@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ZahraTabatabaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Zahra.tabatabaei.ranjbar@gmail.com
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
No - There is not 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