The participants Were randomly assigned to either the intervention group (N=30)or the control group (N=30)using the permuted block technique with block sizes of 6 was determined by the random selection of blocks، with the letters B and A representing the control and intervention groups، respectively.
Settings and conduct
In group A in the 1 & 2 sessions, cannulation would insert with a No.15 needle at room temperature and in 3&4 session, cannulation with needle cooled (-8 c) and the intensity of the patient's pain will be measured. In group B, in contrast to group A. Hemodialysis department Mantasarieh Hospital, Mashhad - 17Shahrivar Hospital, Mashhad
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Presence of both arterial and venous fistula
At least one month elapsed since the creation of the fistula
Full consciousness and ability to articulate pain symptoms
Undergoing hemodialysis three times a week
Absence of dementia or Alzheimer s disease
No active cancer
diagnosis Proficiency in the Persian language
Not currently using anesthesia
Having good vision
Willingness to participate in the study
Ability to communicate pain experiences
Stable hemodynamic status
Absence of muscle and joint injuries
Age 18 and above
exclusion criteria:
Blood pressure below 80/40 mm Hg during fistula cannulation
Failure to insert the needle into the fistula on the first occasion
Presence of phlebitis at the cannulation site.
Intervention groups
In the group A, in session 1, 2, after entering the needle number 15, which is at room temperature, into the artery and vein, the intensity of pain is measured separately using a 10-degree ruler. The researcher uses a cold needle for sessions 4 and 3.In group B, in contrast to group A.
Main outcome variables
The severity of pain after entering the needle for hemodialysis
General information
Reason for update
Acronym
تاثیر بکار بردن سوزن سرد بر شدت درد ناشی از کانولاسیون فیستول شریانی –وریدی بیماران تحت همودیالیز
IRCT registration information
IRCT registration number:IRCT20230902059328N1
Registration date:2023-12-10, 1402/09/19
Registration timing:registered_while_recruiting
Last update:2023-12-10, 1402/09/19
Update count:0
Registration date
2023-12-10, 1402/09/19
Registrant information
Name
Farzaneh Gerivani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 208 6649
Email address
gerivanif4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-30, 1402/05/08
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of insert a cooled needle on arteriovenous fistula puncture-related pain intensity in hemodialysis patients
Public title
pain relief during venipuncture in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of both arterial and venous fistula
At least one month elapsed since the creation of the fistula
Full consciousness and ability to articulate pain symptoms
Undergoing hemodialysis three time a week
Absence of dementia or Alzheimer s disease
No active cancer diagnosis
Proficiency in the persian language
Not currently using anesthesia
Having good vision
Willingness to participate in the study
Ability to communicate pain experiences
Stable hemodynamic status
Absence of muscle and joint injuries
Age 18and above
Exclusion criteria:
Blood pressure below 80/40 mm Hg during fistula cannulation
Failure to insert the needle into the fistula on the first occasion
Presence of phlebitis at the cannulation site.
Age
From 18 days old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants Were randomly assigned to either the intervention group (N=30)or the control group (N=30)using the permuted block technique with block sizes of 6 (AABABB-AAABBB-BABABA-ABABAB-BABABA-AAABBB-ABAABB-BBAABA-BBAABA)the assignment was determined by the random selection of blocks، with the letters A and B representing the control and intervention groups، respectively
Blinding (investigator's opinion)
Single blinded
Blinding description
The groups in the raw data are coded
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Dr Kharazmi Complex, Ferdosi University, Park Squre, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179133859
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.063
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
T85.8
ICD-10 code description
Other specified complications of internal prosthetic devices, implants and grafts, not elsewhere classified
Primary outcomes
1
Description
Pain intensity after needle insertion with normal and cold temperature using 10 degree pain ruler
Timepoint
Session1، 2، 3، 4
Method of measurement
10-point scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
in group A (30), in the first and second sessions, cannulation will be performed with a No. 15 needles at room temperature, and in the third and fourth sessions, cannulation will be performed with a No. 15 needles cooled in the refrigerator (temperature -8 degrees). At the end, the intensity of the patient's pain After piercing the artery and vein, the pain will be measured and recorded separately with a ruler.
Category
Other
2
Description
Intervention gIn group B (30 people), in contrast to group A, in the first and second sessions, cannulation will be performed with a #15 needle cooled in the refrigerator (temperature -8 degrees) and in the third and fourth session, cannulation will be performed with a #15 needle at room temperature, and the pain intensity will be The patient will be measured and recorded separately after the puncture of the artery and vein.roup: