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IRCT20251001067441N1 IRCT 2025-10-09 Kerman University of Medical Sciences Comparison of Thermotherapy and Cryotherapy on Pain caused with Arteriovenous Fistula Cannulation Comparison of Thermotherapy and Cryotherapy on Pain caused with Arteriovenous Fistula Cannulation in Hemodialysis Patients in Kerman 2025-10-22 anticipated 96 Complete https://irct.ir/trial/86528 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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. N/A Patients with chronic kidney disease undergoing hemodialysis. Intervention 1: 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). Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identification of individuals When: Start of the access period: 3 months after publication of results To whom: Data will be accessible to researchers employed at academic and scientific institutions and individuals in industry Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Roqayeh Mehdi Pour Raberi
Beginning of Haft Bagh Olavi Expressway, Alavi campus, Razi School of Nursing and Midwifery, Iran University of Medical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5194 r_mehdipour@kmu.ac.ir Kerman University of Medical Sciences scientific Roqayeh Mehdi Pour Raberi
Beginning of Haft Bagh Olavi Expressway, Alavi campus, Razi School of Nursing and Midwifery, Iran University of Medical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5194 r_mehdipour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 N18.5 Chronic kidney disease, stage 5 Treatment - Other Treatment - Other Treatment - Other 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). 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. 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. 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. Kerman University of Medical Sciences Approved 2025-08-12 Ethics committee of Kerman University of Medical Sciences Haft Bagh Alavi highway kerman Kerman Iran (Islamic Republic of)