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

Not Applicable

Completed

• Conditions: Comfort; Hemolysis; Complementary Therapy; Pain
• Interventions: Device: CoolSense Group

• Registration Number: NCT06144801
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-20
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoolSense Group	CoolSense Group	The responsible researcher carried out the application of the CoolSense device and filled out the patient information form before the arteriovenous fistula cannulation. Meanwhile, the application of the VCS and GCS was conducted both before and after the CoolSense device's application, with the latter occurring after the arteriovenous fistula cannulation. The nephrology charge nurse was responsible for these measurements, using a single device located at the patient's bedside.

Primary Outcome Measures

Name	Time	Method
The The Verbal Category Scale	1 Day	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.
The General Comfort Scale	1 Day	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.

Trial Locations

Locations (1)

Gümüşhane University; 🇹🇷 Gümüşhane, Turkey