The Effect of Coolsense Method on Pain and Comfort in Hemodialysis Patients
Condition: Hemolysis; Complementary Therapy; Pain; Comfort
MeSH terms: Arteriovenous Fistula; Hemolysis
Study type: Interventional

Summary: 
      This study aimed to investigate the impact of the CoolSense method on arteriovenous fistula
      cannulation pain and the comfort levels of hemodialysis patients.
    

Detailed description: 
      Pain is a sensation of unease that arises in response to intense stimulation of nerve endings
      throughout the body. It impacts individuals on various dimensions (emotional, social,
      physical, etc.), often leading to feelings of anxiety and fear. Pain is recognized as a
      subjective experience, influenced by factors such as age and previous pain encounters,
      shaping an individual's perception of pain. During their hospitalization, patients may
      undergo painful procedures repeatedly over an extended period, which can lead to increased
      complications, prolonged hospital stays, and even a decline in overall health. Furthermore,
      pain symptoms can reduce compliance with hemodialysis (HD) treatment, impacting the quality
      of life and comfort of HD patients.

      Effective nursing care interventions must prioritize the needs of patients and ensure their
      comfort and well-being. Comfort is regarded as the foundation of high-quality nursing care.
      Literature suggests that identifying and managing symptoms resulting from illness or
      treatment can enhance patients' comfort levels. Moreover, nurses, in their independent role,
      can effectively minimize pain and prevent potential complications by employing
      non-pharmacological treatment methods, especially in managing pain symptoms.
      Non-pharmacological methods are advantageous due to their affordability, applicability across
      all age groups, ease of use, and cleanliness. In this context, cold application stands out as
      one of the most effective non-pharmacological treatments for alleviating pain symptoms.

      Cold application mitigates pain through two primary mechanisms. Firstly, it indirectly
      induces an analgesic effect by reducing swelling, edema, and muscle spasms caused by trauma
      or inflammation. Secondly, it directly contributes to analgesia by altering the conduction of
      peripheral nerves. Additionally, cold application leads to a decrease in the conduction
      velocity of unmyelinated nerve fibers responsible for transmitting painful stimuli, thereby
      diminishing pain perception. In the relevant literature concerning the application of cold
      therapy, there is a noticeable scarcity of international studies focusing on the CoolSense
      device, which has demonstrated local anesthetic effects preceding medical procedures in
      recent years. Furthermore, there is currently no international or national study available
      that assesses the impact of the CoolSense device on the pain experienced during arteriovenous
      fistula cannulation in hemodialysis (HD) patients. In light of this gap in research, this
      study aimed to investigate the influence of the CoolSense Method on arteriovenous fistula
      cannulation pain and the comfort levels of HD patients.
    

Intervention name(s): CoolSense Group
Intervention type(s): Device
Intervention description(s): Patients in the CoolSense group received a CoolSense device that had been pre-chilled in the freezer for a minimum of one hour. The cover of the CoolSense device was removed, and the arteriovenous fistula, whose metal tip had been cleaned with batikon, was brought into contact with the area where the arteriovenous fistula cannulation would occur. This contact was maintained for 5 seconds, involving circular movements, and the fistula cannulation took place promptly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To determine the sample, power analysis was utilized. With an effect size of 0.80 and a targeted test power of 0.80 (80%), the sample size was computed as 42 patients in total (21 for each group) for both the CoolSense group and the control group. This calculation was performed using the G*Power 3.1.9.6 software, with a significance level of α=0.05, considering the absence of prior experimental studies investigating pain scores in this context. Accounting for potential issues such as participant withdrawal or study-related mortality, each group was increased by 20%, resulting in a total of 50 patients, with 25 patients in each group.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: CoolSense; Hemodialysis; Arteriovenous Fistula; Cannulation; Pain