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The effect of using sand and ice bag on bleeding, hematoma and local pain after percutaneous coronary intervention

Protocol summary

Study aim
Determining the effect of ice bag application on hemorrhagy, hematoma and local pain in Percutaneous Coronary Intervention (PCI) patients.
Design
Clinical trials with control and intervention group, with parallel and randomized groups.
Settings and conduct
This study was conducted in the Angiography section of Imam Reza Hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Age is over 18 years old, non-drug addiction according to one's own words, enough to be alert, not having vascular disease except coronary, Failure to receive the procedure, INR less than 1.8, BMI 18 and 30,
Intervention groups
In the control group (sand bag alone), the sheet arterial will be removed 4 hours after completion of the procedure and after applying the manual pressure to coagulate, the dressing is placed on the floor and patients are placed in the supine position for up to 4 hours and during this time, a sand bag with a fixed weight of 3 kg is placed on an angiographic position. After that, the sandbag is removed and the patient is trained it can rest for up to three hours without moving, then sleep to the healthy feet. In contrast, in the test group (use together of sand and ice bags), the arterial sheet will be removed 4 hours after completion of the procedure and after applying the manual pressure to coagulate, the dressing is placed on the floor And on that ice bag with a cloth (weighing less than 100 grams) then a sand bag with a weight of 3 kg is placed on it for 15 minutes after 15 minutes, the ice pack is removed slowly without removing the bag of sand from the bottom of the sand bag for 45 minutes, the sandbag is in place alone. This cycle is repeated four times (a total of 4 hours), then a sandbag is removed.
Main outcome variables
Determine the effect of ice bag on bleeding, hematoma and local pain after PCI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180315039107N1
Registration date: 2018-04-21, 1397/02/01
Registration timing: retrospective

Last update: 2018-04-21, 1397/02/01
Update count: 0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Maryam Valikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4223 2352
Email address
valikhanim931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
The effect of using sand and ice bag on bleeding, hematoma and local pain after percutaneous coronary intervention
Public title
The effect of ice bag on the hematoma, bleeding and pain of patients pci
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-drug addiction according to one's own words Age over 18 years no pancture More than once to enter the catheter Enough to be alert Not having vascular disease expect coronary Failure to receive Integrilin during the procedure INR less than 1.8 BMI between 18 and 30 Not addictive to sedative medicines
Exclusion criteria:
Very old age (up to 85y)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental numbers
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Crossroad of the Doctora., mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.MUMS.REC.1396.312

Health conditions studied

1

Description of health condition studied
percutaneous coronary intervention through the femoral artery
ICD-10 code
123
ICD-10 code description
انفارکتوس میوکارد

Primary outcomes

1

Description
The amount of bleeding
Timepoint
After completed the procedure , after the removal of the sheet every half hour to three hours, then every hour to three hours and then 12 hours after the removal of the sheet.
Method of measurement
In grams: Measure the weight of bloody gauze using a digital balance and a fraction of the weight of the dry gas.In Cc: To measure the amount of area of bloody gauze with the help of a chessboard.

2

Description
Hematoma
Timepoint
After the completion of the procedure, after removal of the sheet, at 5, 6 and 12 hour after the removal of the sheet.
Method of measurement
Touching the bump caused by hematoma and estimating the hematoma area by measuring the small diameter and large diameter and inserting numbers in the formula:1/2ab3.14

3

Description
local pain
Timepoint
After completed the procedure , after the removal of the sheet every half hour to three hours, then every hour to three hours and then 12 hours after the removal of the sheet.
Method of measurement
Pain Numerical rating scale(PNRS)

Secondary outcomes

empty

Intervention groups

1

Description
Using a bag of ice weighing less than 100 grams plus sand bag after removing the sheet in 4 cycles per hour (15 minutes of ice and sand and 45 minutes sand bag) totaling 4 hours. Ice bag in the form of a plastic bag containing freezing materials (made by Kavian Pars Company size 10 * 20 cm)
Category
Treatment - Devices

2

Description
Control group: Use a bag of sand to weigh 3 kilograms after the removing the sheet for up to 4 hours in succession
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز آموزشی، پژوهشی و درمانی امام رضا(ع)
Full name of responsible person
سید موسی مهدی زاده
Street address
میدان امام رضا(ع)، مرکز آموزشی، پژوهشی و درمانی امام رضا(ع)
City
مشهد
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دكتر محسن تفقدی
Street address
University of Mashhad- next to Hivizadeh Cinema - Mashhad University of Medical Sciences- Deputy of Research & Technology University
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
+98 51 1882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
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
Mashhad University of Medical Sciences
Full name of responsible person
MahdizadehM@mums.ac.ir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Mashhad Crossroad of the Doctora., mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed mousa mahdizadeh
Position
Faculty of Nursing and Midwifery, Mashhad
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Crossroad of the Doctora., mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Valikhani
Position
دانشجوی کارشناسی ارشد پرستاری
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Crossroad of the Doctora., mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 4223 2352
Email
Valikhanim931@mums.ac.ir

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
Only the original outcome information
When the data will become available and for how long
Starting the access period from 1397
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analysis of delivered data is allowed
From where data/document is obtainable
Valikhanim931@mums.ac.ir Maryam Valikhani
What processes are involved for a request to access data/document
In less than one month, information is provided to the applicant by email.
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