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The effect of the cold pack on bruising and pain caused by subcutaneous injection of enoxaparin sodium on elderly patients

Protocol summary

Study aim
Determine the effect of the cold pack on bruising and pain caused by subcutaneous injection of Enoxaparin in the elderly
Design
Each patient in the interventional group constituted his or her own control group. In this study, simple randomization was used. In the case of patients whose last digit of their ID number are odd, the left side of the abdomen are the interventional group and the right side of the abdomen are control group, and if they are paired, their right side of abdomen will be the interventional group and the left side of the of the abdomen are control group.
Settings and conduct
Elderly patients with a MMSE ≥25 and receiving enoxaparin, are block randomization assigned to the right and left abdomen to the control and intervention groups. In the intervention group, for 2 minutes, the cold pack was placed before and after injection in the area, and the severity of the pain during the injection is measured by the visual analogue scale and in the case of bruising, the injection area is 24, 48 and 72 hours after injection with a ruler Millimeters are measured. In the control group, all procedures, except cold pack, will be performed in the same way as the intervention group.
Participants/Inclusion and exclusion criteria
Receiving Enoxaparin; Awareness Based on a MMSE; Being hospitalized at least 3 days; Having informed consent; Lack of injecting medication or other anticoagulants in the abdomen; Not having cold skin allergy; Normal PT, PTT, INR and platelets
Intervention groups
In the abdominal intervention area, the cold pack is placed for 2 minutes before and after the injection
Main outcome variables
The pain score during enoxaparin injection according Visual Analogue Scale, and so bruising size in 24, 48 and 72 hours after enoxaparin injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160606028289N2
Registration date: 2018-12-17, 1397/09/26
Registration timing: registered_while_recruiting

Last update: 2018-12-17, 1397/09/26
Update count: 0
Registration date
2018-12-17, 1397/09/26
Registrant information
Name
Mohammad Esmaeilpour-Bandboni
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13565071
Email address
m_esmaeilpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the cold pack on bruising and pain caused by subcutaneous injection of enoxaparin sodium on elderly patients
Public title
The effect of cold pack on the complications of enoxaparin injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving enoxaparin Being aware according MMSE Being hospitalized at least for 3 days Having informed consent Non-injecting drug or other anticoagulant in the abdomen wall Not having cold skin allergy Normal PT, PTT, INR and platelets
Exclusion criteria:
Discharge earlier than 3 days Skin allergy to the cold pack during intervention Reluctance to continue cooperation Bleeding from the injection site Decreased consciousness in the study process
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
More than 1 sample in each individual
Number of samples in each individual: 2
Subcutaneous injection of Enoxaparin with and without the use of a cold pack on the right and left abdomen of each participant.
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient in the interventional group constituted his or her own control group. In this study, simple randomization was used. In the case of patients whose last digit of their ID number are odd, the left side of the abdomen are the interventional group and the right side of the abdomen are control group, and if they are paired, their right side of abdomen will be the interventional group and the left side of the of the abdomen are control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Guilan University of Medical Sciences
Street address
Vice-Chancellor in Research Affairs of Guilan University of Medical Sciences., facing of 17 Shahrivar Hospital., Shahid Siadati St., Namjoo Street., Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.GUMS.REC.1397.258

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The complications of Enoxaparin injection
Timepoint
During, 24, 48 and 72 hours after injection
Method of measurement
The using of the Visual Analogue Scale and Transparent millimeter ruler

Secondary outcomes

1

Description
The Score of the patients' pain
Timepoint
The measurement of pain during injection
Method of measurement
According to Visual Analogue Scale

2

Description
The measurement of Bruising size
Timepoint
24, 48 and 72 hours after Enoxaparin injection
Method of measurement
Transparent millimeter ruler

Intervention groups

1

Description
Intervention group: Elderly patients with a MMSE ≥25 and receiving enoxaparin, are randomly assigned to the right and left abdomen to the control and intervention groups. In the intervention group, for 2 minutes, the cold pack was placed before and after injection in the area, and the severity of the pain during the injection is measured by the visual analogue scale and in the case of bruising, the injection area is 24, 48 and 72 hours after injection with a ruler Millimeters are measured. In the control group, all procedures, except cold pack, will be performed in the same way as the intervention group.
Category
N/A

2

Description
Control group: In the control group, all procedures, except using a cold pack, will be performed in the same way as the intervention group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Lahijan 22 Aban hospital
Full name of responsible person
Mohammad Esmaeilpour-Bandboni
Street address
Lahijan 22 Aban hospital., Lahijan, Imam Khomeini St
City
Lahijan
Province
Guilan
Postal code
1319544137
Phone
+98 13 4223 5501
Email
hospital22aban@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Vice-Chancellor in Research Affairs of Guilan University of Medical Sciences., facing of 17 shahrivar Hospital., Shahid Siadati St., Namjoo Street., Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Email
drshadmannemati_ent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Esmaeilpour-Bandboni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 11, Golestan St., Laleh 2., P 12
City
Lahijan
Province
Guilan
Postal code
4414918918
Phone
+98 13 4242 4368
Email
esmaeilmmm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Esmaeilpour-Bandboni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 11, Golestan St., Laleh 2., P 12
City
Lahijan
Province
Guilan
Postal code
4414918918
Phone
+98 13 4242 4368
Email
esmaeilmmm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Esmaeilpour-Bandboni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 11, Golestan St., Laleh 2., P 12
City
Lahijan
Province
Guilan
Postal code
4414918918
Phone
+98 13 4242 4368
Email
esmaeilmmm@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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