This study is for comparing the effect of local cold and warmth upon the size of bruising at the injection site of subcutaneous Enoxaparin. It will be conducted in general cardiology department of Emam-Ali hospital in Kermanshah. One-hundred and eighty patients who are above 18years old, who do not be pregnant, has not any coagulation disorders and receive Enoxaparin 60mg two times in a day, will randomly assign to 3 groups through choosing a pocket involved the name of control group or the name of experimental groups. In the experimental group-1: cold compress will be used for patients immediately after administration of Enoxaparin for 20 minutes on injection site. In the experimental group-2: cold compress will be used for them immediately after administration of Enoxaparin for 20 minutes on injection site, then 12hours after that warm compress will be put on the injection site too, and the third group is control group. Injection-site bruising will measured at 24, 48 and 72 hours after each injection by cooperator who don’t know the patient’s group through a millimeter ruler. If there is not any bruising, it is recorded and if there is, the biggest diameter of it measured and recorded. The bruising with size more 5 millimeter will be called as large bruising and with size between 2-5 millimeter will be called as small one. The bruising with size less 2 millimeter, will not be called as bruising. Then sizes of bruising will be compared during 3 days for all participant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040917197N1
Registration date:2014-05-23, 1393/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Sara Amanian
Name of organization / entity
Nursing and Midwifery School of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 9584
Email address
s-amaniyan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local cold and warmth upon the size of bruising at the injection site of subcutaneous Enoxaparin.
Public title
Comparison of the effect of local cold and warmth upon the size of bruising at the injection site of subcutaneous Enoxaparin.
Purpose
Prevention
Inclusion/Exclusion criteria
The patient do not be pregnant; has not any coagulation disorders; the patient has the written order for injection Enoxaparin 60mg by doctor per 12 hours; and there is not record of previous injections during last 24hours in his/her abdominal area.
Exclusion criteria: The drug of Enoxaparin stopped by doctor or changed; there is bleeding in injection area.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of Medical Sciences
Street address
The Central Building of Tehran university of Medical Scienc, keshavarz Street, Qods Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
2597/130/د/92
Health conditions studied
1
Description of health condition studied
Diseases of skin and subcutaneouse tissue
ICD-10 code
XII
ICD-10 code description
L00-L99
Primary outcomes
1
Description
The size of bruising at the injection site of subcutaneous Enoxaparin.
Timepoint
Until 3 days after the injection
Method of measurement
Using a plastic ruler
Secondary outcomes
empty
Intervention groups
1
Description
In the group 1: cold compress are exerted on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes, using a towel, just after every injection in abdomen.
Category
Prevention
2
Description
In the group 2: in addition to exertion of cold compress on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes just after every injection in abdomen, over 12 hours of injection time, warm compress bag will be placed as well on the same point of injection, using a towel, for 20 minutes.
Category
Prevention
3
Description
Third group is called control group and dose not take any special action to these patients except routine injection of subcutaneous Enoxaparin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
General Cardiology Ddepartments of Emem-Ali hospital in Kermanshah
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Universiy of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
The central building of Tehran university of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Universiy 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
The faculty of Nursing and Midwifery of Tehran University of Medical Scienses
Full name of responsible person
Shokooh Varaie
Position
PHD
Other areas of specialty/work
Street address
The faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Tohid Squre, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4327
Fax
Email
shvaraei@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Faculty of Nursing and Midwifery of Tehran University of Medical Scienses
Full name of responsible person
Sara Amanian
Position
Master Sciences Student of Nursing
Other areas of specialty/work
Street address
The Faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Tohid Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 83 1724 9191
Fax
+98 83 1724 8439
Email
amanian51@yahoo.com; daneshfar1987@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)