Protocol summary

Summary
The purpose of this study is to determine the effectiveness of the duration of the Heparin injection on the site pain intensity and bruising extent associated with subcutaneous heparin injection in patients of the PanjAzar hospital, Gorgan. This quasi-experimental study is design on 119 patients hospitalized in Panje Azar, hospital. For each patient two subcutaneous injection, 10 seconds and 30 seconds will be performed. The interval between two injections is 12 hours. Data collection will perform by using a check-list consisting of two sections, demographic characteristics and a section to record the extent of bruising. Extent of bruising are measured using transparent mill metric measuring ruler within 48-60 hours and pain intensity using by Visual AnalogScale (VAS) immediately after heparin injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105105866N3
Registration date: 2011-06-12, 1390/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University Of Medical Sciences
Expected recruitment start date
2009-06-15, 1388/03/25
Expected recruitment end date
2010-06-15, 1389/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on the effect of the duration of subcutaneous heparin injection on bruising and pain in patients hospitalized in the Panj Azar teaching hospital of Gorgan
Public title
Effects of injection duration on pain intensity and bruising اhospitalized patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being a patient for heparin subcutaneous injection; conscious enough to participate and not manipulate injection area by rubbing, scratching and touching the injection site. Exclusion criteria: Discontinuation of subcutaneous injection of heparin or discharge patients within 48 hours, unilateral sensory and neurological defect, any type of skin lesion barrier to assessing bruising, allergic disease, pregnant patients, hematological diseases and the patients who had been given any other injections at the arm site apart from heparin during the days of the research
Age
From 14 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 119
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences Ethics Committee
Street address
Golestan University Of Medical Sciences, Gorgan, Iran
City
Gorgan
Postal code
00981714430360
Approval date
2009-06-14, 1388/03/24
Ethics committee reference number
35.129896

Health conditions studied

empty

Primary outcomes

1

Description
Pain intensity
Timepoint
48 to 60 hours after injection
Method of measurement
Visualَ Analog Scale

2

Description
Extent of bruising
Timepoint
48 to 60 hours after injection
Method of measurement
Using flexible transparent Ruler

Secondary outcomes

empty

Intervention groups

1

Description
For each patient 10 second subcutaneous injection, will be performed and 12 hours later, 30 second injection perform for the same patient.
Category
Treatment - Other

2

Description
For each patient 30 second subcutaneous injection, will be performed and 12 hours later, 10 second injection perform for the same patient.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Panj-Azar Hospital
Full name of responsible person
Street address
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
Vice chancellor for research, Golestan University Of Medical Sciences
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
Akram Sanagoo PHD
Position
Nursing Education, Assistant Professor
Other areas of specialty/work
Street address
Golestan University of medical Sciences, Bouyeh School of Nursing & midwifery, Shastkola Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
Email
a_sanagu@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
Ahmad Shir Afkan MD
Position
Cardiologist
Other areas of specialty/work
Street address
Panj-Azar Teaching Hospital
City
Gorgan
Postal code
Phone
+98 17 1222 0561
Fax
Email
a_sanagu@yahoo.com sanagoo@goums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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