Effect of Injection Duration on Site-Pain Intensity and Bruising Associated with Subcutaneous Enoxaparin sodium in Acute Coronary Syndrome Patients Hospitalized at CCU in Afshar Hospital, Yazd
Aim: Effect of subcutaneous injection duration of enoxaparin (30 seconds and 10 seconds) on pain intensity and bruising at the injection site
Method: from among the 30-75 years old acute coronary syndrome patients hospitalized in CCU who are conscious and were prescribed enoxaparin each 12 hours 70 of them were randomly selected. Then, the injection of subcutaneous enoxaparin was done randomly in each subject through one of the two techniques of 10-30 seconds in the right left side of abdomen and 12 hours later next injection will be done. After that a circle with the radius of 2.5 cm is drawn around it by a waterproof marker (blue marker for 30secends & red marker for 10secends). Pain intensity is measured through VAS before and after each injection. Then, the bruising area is drowning on a millimeter transparent paper 24 and 48 hours later and it will be calculated per square millimeter. In order to reduce bias all injection will be done by the researcher.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110267909N1
Registration date:2011-12-05, 1390/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-05, 1390/09/14
Registrant information
Name
Zahra Najari Varzaneh
Name of organization / entity
Medical University of shahid Sadoughi Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
z.najari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant of Medical University of Shahid Sadoughi Yazd
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Injection Duration on Site-Pain Intensity and Bruising Associated with Subcutaneous Enoxaparin sodium in Acute Coronary Syndrome Patients Hospitalized at CCU in Afshar Hospital, Yazd
Public title
Effect of Injection Duration on Pain and Bruising Associated with Subcutaneous Enoxaparin
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 30 – 75 years old Patients with Acute coronary syndrome; Conscious; without scar and lesion on the site of injection; Non pregnant patients; No coagulating disease
Exclusions criteria: Patient younger than 30 years old and older than 75 years old; Pregnant patients; Scar and lesion on the site of injection; Unconscious; Coagulating disease
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical University of Shahid Sadoughi Yazd
Street address
School of Nursing and Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
62259
Health conditions studied
1
Description of health condition studied
Bruising assossiated with injection
ICD-10 code
T14.0
ICD-10 code description
Superficial injury of unspecified body region
Primary outcomes
1
Description
Injection site pain
Timepoint
Before injection and immediately after injection
Method of measurement
Visual Analogue Scale
2
Description
Bruising at injection site
Timepoint
24 and 48 hours after injection
Method of measurement
per square millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Subcutaneous injection of Enoxaparin-Na for 30 seconds in the right or left side of abdomen
Category
Other
2
Description
Subcutaneous injection of Enoxaparin-Na for 10 seconds in the right or left side of abdomen
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital, Yazd
Full name of responsible person
Zahra najari varzaneh
Street address
Afshar hospial, Jomhoori Boulevard
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical University of Shahid Sadoughi Yazd
Full name of responsible person
Khadijeh Dehghani
Street address
Afshar hospial, Jomhoori Boulevard
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical University of Shahid Sadoughi Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical University of Shahid Sadoughi Yazd, School of Nursing and Midwifery
Full name of responsible person
Zahra Najari Varzaneh
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
z.najari@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Shahid Sadoughi Yazd, School of Nursing and Midwifery
Full name of responsible person
Zahra Najari Narzaneh
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
z.najari@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical university of Shahid Sadoughi Yazd, School of Nursing and Midwifery
Full name of responsible person
Zahra Najari Varzaneh
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Phone
Fax
Email
z.najari@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)