This single blind clinical trial will be done with the aim to comparison of the effects of Arnica ointment and Cold Compress on Pain and bruising caused by enoxaparin injection. A total of 90 patients admitted in the 22-Bahman Hospital in Gonabad will be enrolled. Patients will be selected in available method and randomly divided into three groups (Arnica, cold compress and control) will be allocated. in Arnica group, 1 gram of Arnica Ointment will apply to the injection site and then 30-second duration injection will be performed. In Cold Compress group, 4×2×2 size of ice will apply to the injection site for 5 minutes before the injection and then 30-second duration injection will be performed and there is not any intervention in the control group. Pain intensity is measured through VAS after injection. After that a circle with the radius of 5 cm is drawn around it by a waterproof marker. in the Arnica and cold compress groups, intervention for the patient will be conducted three times a day for three days. Injection-site bruising will measured at 24, 48 and 72 hours after 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 less 5 millimeter, will not be called as bruising and The bruising with size more 5 millimeter will be called bruising. Then sizes of bruising will be compared during 3 days for all participant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020832465N1
Registration date:2017-03-17, 1395/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-17, 1395/12/27
Registrant information
Name
Eshrat Jameiati
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 1606
Email address
e.jameiati@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Arnica ointment and cold compress on pain and bruising caused by enoxaparin injection
Public title
Effects of Arnica ointment and cold on pain and bruising caused by enoxaparin injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Physician's order to receive subcutaneous enoxaparin, Agreed to participate in the study and complete and sign the consent form, orientation to person/place/time/situation, no prescription of narcotic analgesics 4 hours before injection, Exclusion criteria: patient Not wanting to continue studying, allergy to Arnica ointment, loss of consciousness or died patient during the study, coagulation disorders, Presence of scar tissue, any skin lesion or unilateral senso neural obvious defects, receiving other anticoagulants such as warfarin and heparin
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:
90
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
University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Khorasan Razavi Province, Iran, Islamic Republic Of
City
Gonabad
Postal code
9691793718
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.GMU.REC.1395.71
Health conditions studied
1
Description of health condition studied
Injection pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
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
Measuring pain severity
Timepoint
Immediately after injection
Method of measurement
using visual analog scale
Secondary outcomes
1
Description
Measuring of bruise
Timepoint
24 - 48 and 72 hours after injection
Method of measurement
using ruler
Intervention groups
1
Description
In this method 1 gr Arnica ointment is placed on the injection site with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed،Then Arnica ointment at the injection site is used 3 times a day for 3 days
Category
Prevention
2
Description
In this method, a piece of ice the size of 4*2*2 Cm is placed inside the latex gloves and two layers of gas is placed on the injection site 5 minute before the injection, Then piece of ice is used at the injection site for 5 minutes 3 times a day for 3 days.
Category
Prevention
3
Description
Injection Enoxaparin without interference
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Eshrat jameiati
Street address
Gonabad- Naser Khosrow Street
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
The Vice-chancellery for Research and Technology
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Khorasan Razavi Province, Iran, Islamic Republic Of
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Eshrat Jameiati
Position
Nursing graduate student
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Khorasan Razavi Province, Iran, Islamic Republic Of
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 9015
Fax
Email
E.jameiati@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
MR Nematolahei
Position
cardiologist
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Khorasan Razavi Province, Iran, Islamic Republic Of
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 7019
Fax
Email
nematollahi.mr@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Eshrat Jameiati
Position
Nursing graduate student
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences,Next to the Asian Road, Khorasan Razavi Province,Iran, Islamic Republic Of
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
E.jameiati@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)