Comparing the effectiveness of the duration and site of subcutaneous injection of enoxaparin on pain intensity and bruising size in patients hospitalized to the Department of Cardiac Care
Comparing the effectiveness of the duration and site of subcutaneous injection of Enoxaparin on pain intensity and bruising size in patients hospitalized to the Department of Cardiac Care
Design
Clinical trial with two intervention and parallel groups, single blind and randomized with a sample size of 60 people
Settings and conduct
This single blind clinical trial will be conducted on patients admitted to the Cardiac Care departments of Zahedan Hospitals in 2019.After applying the inclusion criteria and purposive Sampling, Patients will be divided into two intervention groups by simple random sampling.The first group received subcutaneous injection of Enoxaparin in the abdomen and arm area with 30 second method and the second group received subcutaneous injection of Enoxaparin with 5 + 15 seconds method.The intensity of pain will be measured immediately after each injection with the visual-analogue scale of pain.The size of the bruise will be measured 24 and 48 hours after each injection.
Determining the intensity of pain and size of bruising will be done by the uninformed researcher of the groups and the injection technique.
Participants/Inclusion and exclusion criteria
All patients admitted to the cardiac care unit with:
Inclusion criteria:
Age range 20 to 75 years
Being able to understand and express pain
Non-inclusion criteria:
Analgesic use, four hours before the intervention
Swelling, ulcer, scratches and erythema in the injection site
Intervention groups
First group: Subcutaneous injection of Enoxaparin in the abdomen and arm area with a 30 second method.
Second group: Subcutaneous injection of Enoxaparin in the abdomen and arm area with a 15 + 5 second method.
Main outcome variables
The intensity of pain caused by subcutaneous injection of Enoxaparin in the abdomen and arm area,
The size of the bruising caused by subcutaneous injection of Enoxaparin in the abdomen and arm area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150106020581N2
Registration date:2019-03-13, 1397/12/22
Registration timing:registered_while_recruiting
Last update:2019-03-13, 1397/12/22
Update count:0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
abbasi.ali@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of the duration and site of subcutaneous injection of enoxaparin on pain intensity and bruising size in patients hospitalized to the Department of Cardiac Care
Public title
Effect of time and place of subcutaneous injection of Enoxaparin on the severity of pain and size of bruising
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 75 years
Physiological stable condition
Being able to understand and express pain
Platelet count in normal range
Body mass index (BMI) ranging from 18.5 to 30
Exclusion criteria:
Analgesic use, four hours before the intervention
Swelling, ulcer, scratches and erythema in the injection site
Muscular and dermal disease and Known coagulopathy
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be randomly assigned to one of two study groups using table of random numbers and will receive the intervention of the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The size of the bruise and the severity of pain will be measured by another person.(Blind researcher)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan university of medical sciences
Street address
Administrative complex of University of Medical Sciences, Khalij Fars blvd, Dr Hesabi square, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.ZAUMS.REC.1397.415
Health conditions studied
1
Description of health condition studied
Pain and bruise
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
Immediately after subcutaneous injection of Enoxaparin
Method of measurement
Visual-Analogue Scale of pain(VAS)
2
Description
Bruising size
Timepoint
24 and 48 hours after each subcutaneous injection of Enoxaparin
Method of measurement
Transparent millimeter ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Enoxaparin medicine according to physician's orders (40 or 60 mg) will be injected subcutaneously into the abdomen and arm area with 30 seconds method.In this method, After the needle is inserted into the subcutaneous space,Enoxaparin will be injected for 30 seconds.
Category
Treatment - Other
2
Description
Intervention group: Enoxaparin medicine according to physician's orders (40 or 60 mg) will be injected subcutaneously into the abdomen and arm area with 5+15 seconds method.In this method, After the needle is inserted into the subcutaneous space,Enoxaparin will be injected for 15 seconds.After the injection is completed, the needle for 5 seconds remaining in the subcutaneous space and will be removed later.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abitaleb hospital
Full name of responsible person
Ali Abbasi Mendi
Street address
Ali ebn abitaleb hospital, Slamat Blvd, Persian Gulf Highway, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
abbasi.ali@gmu.ac.ir
Web page address
http://en.alihos.zaums.ac.ir/#English
2
Recruitment center
Name of recruitment center
Khatam(s) hospital
Full name of responsible person
Ali Abbasi Mendi
Street address
Jamejam Blvd, Khatam(s) hospital, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
abbasi.ali@gmu.ac.ir
Web page address
http://khatam.zaums.ac.ir/#FA
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr noormuhammad bakhshani
Street address
Zahedan University of Medical Sciences, Khalije Fars Blvd, Dr Hesabi Square, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abbasi Mendi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd, Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
abbasi.ali@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abbasi Mendi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd, Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
abbasi.ali@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abbasi Mendi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd,Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
abbasi.ali@gmu.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