The Effect of Coolsense Method on Pain and Comfort in Hemodialysis Patients

Pain Clinical Trial

Official title:

Effect of Coolsense Method on Arteriovenous Fistula Cannulation Pain and Comfort in Hemodialysis Patients: A Single Blind Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06144801
• Other study ID #: RCS10042017
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: November 2023
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 20, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Comfort
• Hemolysis
• Pain

Intervention

Device:
• CoolSense Group
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.

Locations

Country	Name	City	State
Turkey	Gümüshane University	Gümüshane

Sponsors (2)

Lead Sponsor	Collaborator
Karadeniz Technical University	Gümüshane University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The The Verbal Category Scale	The Scale is a pain assessment tool based on the patient's selection of the most appropriate word to describe their pain state. Patients rate their pain on a 0-4 point scale, where 0 point indicates "no pain," 1 point indicates "mild pain," 2 points indicate "severe pain," 3 points indicate "very severe pain," and 4 points indicate "unbearable pain".; It was determined that the pain decreased after CoolsenSe application.	1 Day
Primary	The General Comfort Scale	It employs a four-point Likert-type scale, encompassing three sub-dimensions (relief, relaxation, and superiority-coping with problems) and 48 items. In this study, a score of 1 indicates a low comfort level, while a score of 4 represents a high comfort level.; It was determined that comfort increased after CoolsenSe application.	1 Day