Clinical trial NCT06144801: The Effect of Coolsense Method on Pain and Comfort in Hemodialysis Patients
Official title: Effect of Coolsense Method on Arteriovenous Fistula Cannulation Pain and Comfort in Hemodialysis Patients: A Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Complementary Therapy
Pain
Comfort
Keywords: CoolSense
Hemodialysis
Arteriovenous Fistula
Cannulation
Pain
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: Gümüşhane Universıty
First posted: 2023-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion criteria;

For the patient:

1. Being 18 years of age or older,
2. Receiving HD treatment through the fistula,
3. Being conscious and able to communicate with no impairment in mental or cognitive functions,
4. Taking sedatives or analgesics at least 6 hours ago,
5. Having no diabetes-related neuropathy,
6. Having no alcohol or narcotic dependence.

Exclusion criteria;

1. Refusing to participate in the study,
2. Being 18 years of age or younger,
3. Receiving dialysis treatment through a catheter,
4. Having diabetes mellitus for more than 10 years or no diabetes-related neuropathy,
5. Having a history of addiction or diagnosed psychological disorders,
6. Having an unstable hemodynamic status.

Primary outcomes:
measure: The The Verbal Category Scale
timeFrame: 1 Day
measure: The General Comfort Scale
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane University
Study officials:
affiliation: Gümüşhane Universıty
name: Hatice Demirağ, Assist Prof.
role: PRINCIPAL_INVESTIGATOR
References: