Comparison of Thermotherapy and Cryotherapy on Pain Associated with Arteriovenous Fistula Cannulation in Hemodialysis Patients in Kerman in 2025
Design
An intervention study of the clinical trial type in parallel, prospective, and single-blind design with randomly permuted blocks of size six and a sample size of 96 patients will be designed. The randomization list is based on the Sealed Envelope Ltd. online system 2024. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 13 May 2025]. Created.
Settings and conduct
The study population will consist of all eligible patients with end-stage chronic kidney disease who attend dialysis centers affiliated with Kerman University of Medical Sciences in 2025
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 or older, at least two hemodialysis sessions in a week, at least three months of arteriovenous fistula patency with intact skin. Exclusion criteria: failing the fistula's first cannulation attempt and using anesthetic agents or medications in the fistula region within the previous 24 hours.
Intervention groups
Control Group: In the control group, cannulation will be performed by the usual method and patients in this group will receive standard care. One minute after cannulation is performed by a skilled nurse, pain intensity will be measured using the NRS scale.
Warm therapy intervention group: After confirming that the temperature of the warm compress reaches 40 degrees Celsius with the infrared device (Imperial Digital Thermometer CK-T 1502), the intervention will be applied precisely at the fistula site for ten minutes.
Cold therapy intervention group: A cold compress will be applied precisely at the fistula site for ten minutes.
Main outcome variables
Pain improvement due to fistula cannulation in patients on hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251001067441N1
Registration date:2025-10-09, 1404/07/17
Registration timing:prospective
Last update:2025-10-09, 1404/07/17
Update count:0
Registration date
2025-10-09, 1404/07/17
Registrant information
Name
Zahra Isari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 2209
Email address
isarizahra2588@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-22, 1404/07/30
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Thermotherapy and Cryotherapy on Pain caused with Arteriovenous Fistula Cannulation in Hemodialysis Patients in Kerman
Public title
Comparison of Thermotherapy and Cryotherapy on Pain caused with Arteriovenous Fistula Cannulation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
18 years old or older
Fully aware of location, time, and person
Having intact senses and the ability to speak
Undergoing hemodialysis program at least twice a week
Having an arteriovenous fistula for at least three months
Healthy skin around the arteriovenous fistula area
Exclusion criteria:
Unsuccessful first attempt at cannulation of the fistula
Use of anesthetic substances or medications in the fistula area in the past 24 hours
Decrease in level of consciousness or patient death
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the probability of dropout, the final sample size was determined as 32 participants per group. Participants will be allocated to groups in blocks of six in a randomised manner.
The randomisation list was generated online using Sealed Envelope Ltd. 2024. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 13 May 2025].
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding of participants is not feasible, because, in addition to the nature of the intervention, there will be a very short interval between the application of heat therapy or cryotherapy and data collection. Nevertheless, there will be no information as to which data pertain to the intervention and control groups, though it will be recorded which data belong to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Haft Bagh Alavi highway
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2025-08-12, 1404/05/21
Ethics committee reference number
IR.KMU.REC.1404.264
Health conditions studied
1
Description of health condition studied
Patients with chronic kidney disease undergoing hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Pain by Numeric Rating Scale (NRS)
Timepoint
Pain intensity before the procedure and one minute after inserting the hemodialysis needle and securing the needles
Method of measurement
Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, cannulation will be performed using the conventional method, and patients in this group will receive standard care. One minute after cannulation is performed by a skilled nurse, pain intensity will be measured using the Numeric Rating Scale (NRS).
Category
Treatment - Other
2
Description
Intervention group: Thermotherapy: A warm compress will be heated in a microwave for 2 minutes. After confirming that the temperature reaches 40°C, the intervention will be applied precisely at the fistula site for 10 minutes using infrared guidance (measured with the Imperial Digital Thermometer CK-T 1502). The application will continue up to 1 minute before cannulation. After 10 minutes, the warm compress will be removed, and the area will be disinfected with a 70% ethanol swab for 30 seconds. Cannulation will then be performed by an experienced nurse. One minute after cannulation, pain intensity will be assessed using the Numerical Rating Scale (NRS). If any adverse event occurs, the intervention will be halted and the physician will be informed.
Category
Treatment - Other
3
Description
Intervention group: Cryotherapy: A cold compress will be applied for ten minutes precisely at the fistula site. The cold compress will be placed with light pressure in an intermittent manner (fifteen seconds of application followed by a fifteen-second rest for every two minutes of cryotherapy, totaling ten minutes) and will continue up to one minute before cannulation. After ten minutes, the cold compress will be removed, and the area will be disinfected with a 70% ethanol swab for 30 seconds. Cannulation will then be performed by an experienced nurse. One minute after cannulation, pain intensity will be assessed using the Numerical Rating Scale (NRS). If any adverse event occurs, the intervention will be halted and the physician will be informed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Roya Esfandiarpour
Street address
Shafa Educational and Medical Center, Kosar Blvd
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3121 7284
Email
shafahospital@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Nahid Hajmohammadi
Street address
Afzali Pour Educational, Medical Center, next to Shahid Bahonar University, Imam Khomeini Expressway (RA)
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5419
Email
afzalih@kmu.ac.ir
3
Recruitment center
Name of recruitment center
Javadalaeme Clinic
Full name of responsible person
Mohammad Hossein Pour Ebrahimi
Street address
Delshad Street, 25th Abdozor Street, Northern Abdozor Street
City
Kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3253 1433
Email
r_ghazizadeh@kmu.ac.ir
4
Recruitment center
Name of recruitment center
Samin al-Hujjat (A) Charity Institute
Full name of responsible person
Ali Shamsinia
Street address
End of Shaheed Raeisi Street (formerly Rajai)
City
Kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3271 1779
Email
info@samen-darman.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi
Street address
Semayeh Crossroads (Tahammas Abad) at the beginning of Ibn Sina Street, Research and Technology Department
City
Kerman
Province
Kerman
Postal code
7613753767
Phone
+98 34 3226 3821
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Roqayeh Mehdi Pour Raberi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Haft Bagh Olavi Expressway, Alavi campus, Razi School of Nursing and Midwifery, Iran University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5194
Email
r_mehdipour@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roqayeh Mehdi Pour Raberi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Haft Bagh Olavi Expressway, Alavi campus, Razi School of Nursing and Midwifery, Iran University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5194
Email
r_mehdipour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roqayeh Mehdi Pour Raberi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Haft Bagh Olavi Expressway, Alavi campus, Razi School of Nursing and Midwifery, Iran University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5194
Email
r_mehdipour@kmu.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
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identification of individuals
When the data will become available and for how long
Start of the access period: 3 months after publication of results
To whom data/document is available
Data will be accessible to researchers employed at academic and scientific institutions and individuals in industry
Under which criteria data/document could be used
With authorization from the relevant bodies, non-identifiable documents will be made available to individuals. Also, the data will be usable only for scientific and research purposes or for industry.
From where data/document is obtainable
To obtain the documents, applicants can contact Zahra Isari at Kerman University of Medical Sciences, Razi School of Nursing and Midwifery, phone number 00989134400639 or email isarizahra2588@gmail.com.
What processes are involved for a request to access data/document
Applicants should submit their request by sending a letter to the specified email from the relevant organ. Researchers will respond to their email as soon as possible and no later than one week.