1. Home
  2. Approved trials
  3. » فارسی

Assessing the effect of applying local cold and hot pack on the bruising extent of Enoxaparin sodium injection site in patients admitted

Protocol summary

Study aim
determine the effect of topical cold and heat on bruises induced by subcutaneous injection of enoxaparin sodium in patients admitted to the orthopedic ward of Poursina Hospital in Rasht.
Design
This study is a single randomized controlled clinical trial by parallel group.The samples size is 74. At first, the samples are selected by convenience sampling method. Then, allocated in the intervention group 1 and intervention group 2 .
Settings and conduct
the study is conducted in patients admitted to the orthopedic ward of Poursina Hospital in Rasht.In intervention group 1 (local cold) after administration of enoxaparin sodium, a cold pack is applied at a place of injection for 20 minutes. In the intervention group 2 (local cold-heat), in addition to the cold pack for 20 minutes, 24 hours later, the warm pack for 20 minutes is applied.The bruising extent is measured by a researcher fellow with ruler for up to 3 days at 24, 48, 72 hours after injection in both groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria:attendance in the first 24 h of admission ; requiring hospital admission for at least 72 h after receiving the second injection in the left abdomen; enoxaparin sodium ordering (6000 u ) normal coagulation,renal function,Hct & Plt tests ; No lesions on the abdomen. exclusion criteria :any change in the clinical condition is required changing in the amount or discontinuation of the drug, injection in right side by personel & unwillingness to continue cooperation.
Intervention groups
In intervention group 1 (local cold) after administration of enoxaparin sodium, a cold pack is applied at a place of injection for 20 minutes . In the intervention group 2 (local cold-heat), in addition to the cold pack for 20 minutes, 24 hours later, the warm pack for 20 minutes is applied.
Main outcome variables
The extent of bruising in area of Enoxaparin sodium in Milimeter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180623040206N1
Registration date: 2018-07-17, 1397/04/26
Registration timing: registered_while_recruiting

Last update: 2018-07-17, 1397/04/26
Update count: 0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
ataollah asadi louyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
aa.louyeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-10, 1397/04/19
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of applying local cold and hot pack on the bruising extent of Enoxaparin sodium injection site in patients admitted
Public title
"Assessing the effect of applying local cold and hot pack on the bruising extent of Enoxaparin sodium injection site in patients admitted "
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
requiring hospital admission for at least 72 hours after receiving the second injection in the left abdomen treatment with Enoxaparin sodium with a dose of 6000 units having the results of the latest coagulation tests include INR, PTT, PT in the range of therapy (up to 1.5-2.5 as normal), normal amounts of platelets and hematocrit adequate renal function (creatinine 1.5-0.5 mg / dL) lack of extensive skin lesions on the abdomen such as extensive scarring due to surgery or burn lack of conditions preventing the correct implementation of the Enoxaparin injection method such as sever Ascites abdominal bruises from the previous injection satisfaction to participate in the research by signing a written consent
Exclusion criteria:
event of any change in the clinical condition is required changing in the amount or discontinuation of the drug performing subcutaneous injections Enoxaparin sodium on the right side of the abdomen by personnel unwillingness to continue cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
The samples size is 74. At first, the samples are selected by convenience sampling method and based on the inclusion criteria. Then, 37 subjects are allocated in the intervention group 1 (Local cold on the right side of the abdomen) and 37 in the intervention group 2 (Local cold- heat on the right side of the abdomen) based on the randomized blocking on a computer and obtaining a precise list in four block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by afellow trained researcher who does not know any information about injection methods
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Eastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
93345-41938
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.GUMS.REC.1397.094

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 extent of bruising in area of Enoxaparin sodium in Milimeter
Timepoint
24,48 and 72 hours after intervention
Method of measurement
Recording the bruising extent based on multiplication of the largest diameter in the smallest diameter (by flexible ruler in millimeter) in prepared form.

2

Description
The incidence of bruising in site of Enoxaparin sodium injection:discoloration in skin to violet color at least 2 mm
Timepoint
24,48 and 72 hours after intervention
Method of measurement
Recording the observed bruising in prepared form by flexible ruler in millimeter)to measure skin discoloration

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying a cold pack at a place of injection for 20 minutes with a temperature of 15 to 18 ° C. . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet.
Category
Prevention

2

Description
Intervention group2: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying the cold pack for 20 minutes, 24 hours later, the warm pack with a temperature 40-43 ° C for 20 minutes is applied . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina educational therapeutic center
Full name of responsible person
Ataollah asadi louyeh
Street address
Poursina Crossing - Poursina Hospital
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 3970
Fax
+98 13 3333 9842
Email
aa.louyeh@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Deputy of Guilan University of Medical Sciences.
Full name of responsible person
Shadman Nemati
Street address
Namjou St., shahid siadati .,Research and Technology Deputy of Guilan University of Medical Sciences.
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research/303/%d8%b5%d9%81%d8%ad%d9%87-%d8%a7%d8%b5%d9%84%db%8c.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy of Guilan University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan university of medical sciences,Beheshti nursing and midwifery college
Full name of responsible person
Ataollah asadi louyeh
Position
instructor
Latest degree
Master
Other areas of specialty/work
Health policy
Street address
Daneshjoo street, Western Beheshti Boulvard, Beheshti nursing and midwifery college
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
aa.louyeh@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan university of medical sciences,Beheshti nursing and midwifery college
Full name of responsible person
Ataollah asadi louyeh
Position
instructor
Latest degree
Master
Other areas of specialty/work
Health policy
Street address
Beheshti nursing and midwifery college, Daneshjoo street, Western Beheshti Boulvard
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
aa.louyeh@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

Person responsible for updating data

Contact
Name of organization / entity
Guilan university of medical sciences ,Beheshti nursing and midwifery college
Full name of responsible person
Ataollah asadi louyeh
Position
instructor
Latest degree
Master
Other areas of specialty/work
Health policy
Street address
Beheshti nursing and midwifery college, Daneshjoo street, Western Beheshti Boulvard
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
aa.louyeh@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total of data is Shareable after unidentifiable the people.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Meta analysis
From where data/document is obtainable
Ataollah Asadi Louyeh Guilan University of Medical Sciences. Shahid Beheshti Nursing and Midwifery School of Rasht
What processes are involved for a request to access data/document
contact by email
Comments
Loading...