Protocol summary

Study aim
Investigating the effect of cold compress on pain caused by vascular access through the radial artery
Design
In this study, we will use the block randomization method, without blinding, with 2 control and intervention groups, which is performed on a total of 60 patients, cards were used to randomize the patients in the groups.
Settings and conduct
The target population of the current study is patients with acute coronary syndrome, who are admitted to the post-angiography department of Amir al-Momenin and Quds Arak hospitals after radial angiography. Then, after allocating the patients to the test and control groups by the method of 4 blocks, the patients of the test group, for the patients of the test group, liquid injection inside the bracelet with a temperature of 1-2 degrees Celsius and placing a cold water compress with a volume of 100 mg with a temperature of 1-2 degrees Celsius will be done for 60 minutes. Also, the usual hospital care will be done for the control group. The amount of pain in the previous intervals, 20, 40, 60, will be measured with a VAS tool.
Participants/Inclusion and exclusion criteria
Ability to give informed consent, age 18-80, candidate for radial angiography and having a transparent cuffed bracelet, absence of sensory disorders and diseases affecting the transmission of nerve pain messages, insensitivity to cold, Exclusion criteria: cardiac rhythm disorder, patient hemodynamic disorder, Drug addiction
Intervention groups
Intervention group: due to the pain in the puncture area after the completion of angiography, we decided to measure the effect of cold compress on recovery and relief of puncture pain.. The control group includes monitoring the patient and examining the puncture area in terms of bleeding and emptying the liquid inside the cuff on a regular basis
Main outcome variables
Frequency and intensity of hand pain by visual analog scale tool

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240305061173N1
Registration date: 2024-08-01, 1403/05/11
Registration timing: retrospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Mohammad abed Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3369 0389
Email address
mohammadam.mohammadir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2024-07-08, 1403/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of cold compress on pain subsequent to vascular access through the radial artery
Public title
Investigation of cold compress on pain caused by radial angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Age 18-80 years Candidate for radial angiography Having a transparent cuffed bracelet Absence of sensory disorders and diseases affecting the transmission of nerve pain messages, including diabetes, types of neuropathy, Raynaud's syndrome, sickle cell anemia, etc. Insensitivity to cold
Exclusion criteria:
Heart rhythm disorder Disturbance in the patient's hemodynamics Drug addiction
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization will be used in this study. In this study, the randomization units are individual and the patients who meet the entry criteria are randomly assigned to two groups A and B based on the desire of the people. In this study, six modes (AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be created by the method of quadruple blocks. The different states of the blocks will be written on cardboard cards with the same color and size. Considering the sample size (60 people) and the six states of the block, the cards will be randomly selected 10 times with replacement. The pattern of each block will determine the order of patients in the intervention (A) and control (B) groups.
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2024-02-03, 1402/11/14
Ethics committee reference number
IR.ARAKMU.REC.1402.226

Health conditions studied

1

Description of health condition studied
Unstable angina
ICD-10 code
I20.0
ICD-10 code description
Unstable angina

Primary outcomes

1

Description
Puncture pain score
Timepoint
20, 40, 60 minutes before intervention
Method of measurement
Using a visual analog scale (VAS) tool

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group includes: injection of liquid with a temperature of 1 to 2 degrees inside the bracelet and using a cold compress of 10 x 5 cm with a volume of 100 mg with a temperature of 1 to 2 degrees Celsius, which will be measured with a kt908 digital thermometer and covered with sterile gas, which After entering the department, a cold pack will be placed on the puncture area for 20 minutes within an hour, and the pain level before the cold pack (zero minute), immediately after the cold pack (20 minutes) and 40, 60 minutes with the VAS ruler tool will be measured.
Category
Treatment - Other

2

Description
Control group:Control group: includes the usual routine of the hospital (monitoring the patient and examining the puncture area in terms of bleeding and emptying the liquid inside the cuff on a regular basis)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirul Mominin Hospital, Quds Hospital, Sina Hospital
Full name of responsible person
mohammad abed mohammadi
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
arak
Province
Markazi
Postal code
3818759335
Phone
+98 936 580 4750
Email
mohammadam.mohammadir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Dawood Hekmat Po
Street address
Research Assist،Arak University of Medical Sciences،Basij square،Sardasht،Arak
City
arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3638 3417
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Abed -Mohammadi
Position
medical_ surgery MSCs ، student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3369 0389
Email
mohammadam.mohammadir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ahmad Raza abedi
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
third floor،Bluebal،University of the payambarazam،Basij square،sardasht،Arak
City
arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3524 3417
Email
dr.abediar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Abed Mohammadi
Position
Senior student of medical_ surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
next to hedayat6،moalem street
City
arak
Province
Markazi
Postal code
3818759335
Phone
+98 86 3369 0389
Email
mohammadammohammadir@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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