Effect of implementing local cooling in different times versus no implementation on pain severity and extend of bruise due to subcutaneous enoxaparin injection in cardiovascular patients: a randomized clinical trial
Objectives: To assess the effect of implementing local cooling in different times versus no implementation on pain severity and extend of bruise due to subcutaneous enoxaparin injection in cardiovascular patients
Design: a randomized clinical trial.
Setting and conduct: The eligible cardiovascular patients who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 30 to 70 years; (b) indication of subcutaneous enoxaparin injection for the first time; (c) conscious and ability to percept and state the pain.
Exclusion criteria: (a) receiving analgesic within past 4 hours; (b) death or discharge during 72 hours; (c) coagulopathy; (d) using anticoagulant agents.
Intervention group: (a) local cooling using ice bag for 180 seconds 5 minutes before subcutaneous enoxaparin injection; (b) local cooling using ice bag for 180 seconds immediately after subcutaneous enoxaparin injection.
Control group: Subcutaneous enoxaparin injection without any intervention.
Primary outcome: Measuring pain severity using visual analog scale immediately after injection.
Secondary outcome: Measuring extend of bruise using ruler 12, 24, and 48 hours after injection.
Randomization: The patients will be randomly assigned to intervention and control groups using random number table.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602029014N92
Registration date:2016-02-11, 1394/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementing local cooling in different times versus no implementation on pain severity and extend of bruise due to subcutaneous enoxaparin injection in cardiovascular patients: a randomized clinical trial
Public title
Effect of implementing local cooling in different times versus no implementation on pain severity and extend of bruise due to subcutaneous enoxaparin injection in cardiovascular patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 30 to 70 years; (b) indication of subcutaneous enoxaparin injection for the first time; (c) conscious and ability to percept and state the pain.
Exclusion criteria: (a) receiving analgesic within past 4 hours; (b) death or discharge during 72 hours; (c) coagulopathy; (d) using anticoagulant agents.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using random number table.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.UMSHA.REC.1394.441
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Measuring pain severity
Timepoint
immediately after injection
Method of measurement
using visual analog scale
Secondary outcomes
1
Description
Measuring extend of bruise
Timepoint
12, 24, and 48 hours after injection
Method of measurement
using ruler
Intervention groups
1
Description
ocal cooling using ice bag for 180 seconds 5 minutes before subcutaneous enoxaparin injection
Category
Prevention
2
Description
local cooling using ice bag for 180 seconds immediately after subcutaneous enoxaparin injection
Category
Prevention
3
Description
Subcutaneous enoxaparin injection without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mostafa Najafi
Street address
Farshchian Hospital, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Mostafa Najafi
Position
Nursing Student
Other areas of specialty/work
Street address
Farshchian Hospital, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
mostafanajafi115@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Mohsen Salavati
Position
Nursing Trainer
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0160
Fax
Email
salavatimohsen42@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)