The effect of local cold application and injection duration, on the occurrence of bruising and pain at the injection site in subcutaneous enoxaparin sodium injections
The purpose of this study is to determine and compare the effect of local cold application and injection duration on occurrence of pain and bruising injection site in patients whom receive subcutaneous enoxaparine sodium injections . Subcutaneous administration of enoxaparine is a common nursing intervention. Heparin preparations are widely used for post-surgical prophylaxis, deep vein thrombosis and pulmonary emboli. This subcutaneous injection often causes problem such as bruise and pain at site of injection. This problem may lead to anxiety and disruption of body image and refuse of treatment in patients. 72 patients who receive enoxaparine will be divided into four groups. Each group consist of 18 patients. First group receive 10 second injection duration (routine method of injections); second group: cold apply to injection site for 5 minute before10 second injection duration; third group: 10 second injection duration and waiting 10 second before exit needle; fourth group: cold apply for 5 minute before10 second injection duration and waiting10 seconds before exit needle. Following each injection, the patient pain intensity will be measured immediately by visual analogue scale. The site of bruising will be measured at 24, 48, and 72 hours after each injection by a plastic ruler.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201158731N1
Registration date:2012-08-14, 1391/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Hossein Rahmani_anaraki
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
rahmani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of medical sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-08-08, 1391/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local cold application and injection duration, on the occurrence of bruising and pain at the injection site in subcutaneous enoxaparin sodium injections
Public title
The effect of local cold application and injection duration on the occurrence of bruising and pain at the injection site in subcutaneous enoxaparin sodium injections
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patient who receives subcutaneous injection of 60mg anoxaparine twice a day as treatment program; not to have coagulation disorders; not to have other injection in abdomen site; enable to express pain of injection; not to use analgesic medication four hours before injection; upper 18 and lower 65 years old; to have written approval. Exclusion criteria: patients who have abnormal coagulation; any change anoxaparine doses; have any other injections at the abdominal site except anoxaparine during the days of the research.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan university of medical sciences
Street address
kilometer 2 of Gorgan-Sari road
City
Gorgan
Postal code
49341-74515
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
533/35/گ پ
Health conditions studied
1
Description of health condition studied
skin and subcutaneous injury
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
pain
Timepoint
immediately
Method of measurement
visual analog scale
2
Description
skin bruise
Timepoint
24, 48, and 72 hours later
Method of measurement
millimeter
Secondary outcomes
empty
Intervention groups
1
Description
first group: routine method of injection, subcutaneous anoxaparine (10 second duration injection technique)
Category
Prevention
2
Description
second group: cold apply to injection site for 5 minute before, 10 second injection duration
Category
Prevention
3
Description
third group: 10 second injection duration and waiting 10 second before exit needle
Category
Prevention
4
Description
fourth group: cold apply for 5 minute before 10 second injection duration and waiting 10 seconds before exit needle.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar Educational and Medical Center
Full name of responsible person
Street address
5Azar street, Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Dr. Mohsen Aarabi
Street address
kilometer 2 Gorgan-Sari road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan university of medical sciences
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
Golestan university of medical sciences
Full name of responsible person
Hossein Rahmani anaraki
Position
academic instructor
Other areas of specialty/work
Street address
Golestan university of medical sciences
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
rahmani@goums.ac.ir ; rahmani_anaraki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Hossein Rahmani anaraki
Position
academic instructor
Other areas of specialty/work
Street address
Golestan university of medical sciences
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
rahmani@goums.ac.ir ; rahmani_anaraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Hossein Rahmani anaraki
Position
academic instructor
Other areas of specialty/work
Street address
Golestan university of medical sciences
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)