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Comparing the Effect of Cryotherapy on Hugo point and the Pain of Vascular Needles Insertion in Hemodialysis Patient

Protocol summary

Study aim
The unpleasant and stressful experiences of patients should be minimized.
Design
Clinical trial with two intervention groups, with parallel groups, without strain, simple randomization, table of random numbers, on 56 patients.
Settings and conduct
This study is carried out in Hami Arak Dialysis Center.Group A patients are placed in the venipuncture site under the intervention of using an ice pack. The ice bag is placed for 10 minutes on the place where the vascular needles are inserted and is moved clockwise with moderate pressure. After ten minutes, the ice pack is remove, after which cannulation is performed, and then pain intensity is measured with the VAS instrument within 1 minute at most after cannulation. Group B patients are placed at Hugo's point under the intervention of using an ice bag. In this method, the ice bag is moved clockwise for 10 minutes on the Hugo point, between the thumb and forefinger, on the back of the hand opposite to the cannulation, with moderate pressure. After ten minutes, the cannulation is done and then within 1 minute after the cannulation, the pain level is measured with the VAS tool.
Participants/Inclusion and exclusion criteria
Patient age, between 18-70 years. Having a fistula, at least 3 months. The patient should undergo hemodialysis 3 times a week. Regular hemodialysis
Intervention groups
Using an ice pack at the two places where the needle is inserted and Hugo's point, in order to compare the reduction of pain in these two points
Main outcome variables
The treatment team can reduce the pain and suffering of patients by using a local and easy method and increase the quality of nursing services; Raising the awareness of nurses about the benefits of using local pain relief methods and paying more attention to this issue.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220612055152N1
Registration date: 2022-09-10, 1401/06/19
Registration timing: retrospective

Last update: 2022-09-10, 1401/06/19
Update count: 0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Atefeh Sasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 9403
Email address
atefeh.sasani82@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2022-08-18, 1401/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Cryotherapy on Hugo point and the Pain of Vascular Needles Insertion in Hemodialysis Patient
Public title
"effect of cold therapy on pain"؛ "effect of Hugo point cold therapy on pain"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the patient to participate in the study and have informed consent The patient's age should be between 18-70 years. The patient should have consciousness, verbal ability and normal sensation. Cannulation is not an emergency. The patient should not have any other pain in the hands except the pain caused by the cannulation. Lack of anesthesia and neuropathy disorders and peripheral vascular diseases at the cannulation site Do not have a history of mental illness. The patient has not used painkillers, anesthetics or drugs in the last 8 hours. Do not have skin problems such as eczema, burns, wounds or skin cuts at the cannulation site. Having a fistula, at least 3 months. The patient should undergo hemodialysis 3 times a week. Regular hemodialysis
Exclusion criteria:
The patient's unwillingness to cooperate with the study Allergy to cold Improper cannulation angle or more than one cannulation attempt
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The randomization unit is individual. The randomization tool is the table of random numbers. We number the statistical community from 1 to the last... and record each of the numbers on similar and identical small cards. Then we put all the cards in a box and every time after shaking the box, we randomly take out one card from the box and record its number. We continue this process until the desired number of sample units is obtained.
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
Arak University of Medical Sciences
Street address
22 Bahman St., Postal code 3813747773
City
Arak
Province
Markazi
Postal code
3813747773
Approval date
2022-03-07, 1400/12/16
Ethics committee reference number
IR.ARAKMU.REC.1400.329

Health conditions studied

1

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

Primary outcomes

1

Description
Pain score in Visual Analogue Scale tool
Timepoint
Within 1 minute after cannulation, the pain level is measured with the Visual Analogue Scale tool.
Method of measurement
Visual Analogue Scale tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are divided into two intervention groups, first and second. The cooler used in this research is made by YAKHPACK company of Iran. Its dimensions are 10 x 10 cm and its weight is approximately 100 grams, which is made of gelatinous and non-toxic materials. The alcohol pad used is from Saba Tab Company. The patients of the first intervention group are placed in the venipuncture site under the intervention of using an ice pack. In this method, the needle entry point is marked before placing the ice pack. Then The ice pack is placed for 10 minutes on the place where the vascular needles are inserted and moved clockwise with medium pressure. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the ice pack is removed and the area is sterilized with an alcohol pad, after which cannulation is performed, and then pain intensity is measured with a Visual Analogue Scale tool within 1 minute after cannulation.
Category
Prevention

2

Description
Intervention group: The patients of the second intervention group are placed in Hugo's point under the intervention of using an ice pack. In this method, the ice pack is moved for 10 minutes on the Hugo point, between the thumb and forefinger, on the back of the hand opposite to the cannulation, with moderate pressure, in a clockwise direction. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the cannulation is done and then within 1 minute after the cannulation, the pain level is measured with the Visual Analogue Scale tool.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hami Arak Dialysis Center
Full name of responsible person
Ali Nowrozi
Street address
Shahrak Gerdo, Saadi St., Razi St
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3477 9080
Email
arak@hamidc.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Sardasht, Basij Square, University Complex of the Prophet (PBUH)
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Fax
+98 86 3417 3524
Email
nursing.school@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
Atefeh Sasani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
22 Bahman St., Postal code 3813747773
City
Arak
Province
Markazi
Postal code
3813747773
Phone
+98 86 3222 9403
Email
atefeh.sasani82@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Atefeh Sasani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
22 Bahman St., Postal code 3813747773
City
Arak
Province
Markazi
Postal code
3813747773
Phone
+98 86 3222 9403
Email
atefeh.sasani82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Atefeh Sasani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
22 Bahman St., Postal code 3813747773
City
Arak
Province
Markazi
Postal code
3813747773
Phone
+98 86 3222 9403
Email
atefeh.sasani82@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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