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

NCT06144801 | Completed

• 1 other identifier: RCS10042017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemolysis; Complementary Therapy; Pain; Comfort

Keywords

CoolSense; Hemodialysis; Arteriovenous Fistula; Cannulation; Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

CoolSense Group

EXPERIMENTAL

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.

Device: CoolSense Group

Control Group

NO INTERVENTION

Patients in the control group underwent routine HD arteriovenous fistula cannulation and received HD treatment following the hospital's established protocol. Data collection tools were only administered to the participants before and after the study.

Interventions

CoolSense Group DEVICE

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.

CoolSense Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Gümüşhane Universıty: collaborator

Study Sites (1)

Gümüşhane University

Gümüşhane, 29600, Turkey (Türkiye)

Location

Related Publications (1)

• Demirag H, Kulakac N. The effect of using a local skin cooling device on arteriovenous fistula cannulation pain and comfort level of patients on hemodialysis: A single-blind randomized controlled study. Hemodial Int. 2025 Jan;29(1):47-55. doi: 10.1111/hdi.13190. Epub 2024 Oct 28.

  PMID: 39467833 DERIVED

MeSH Terms

Conditions

Hemolysis; Pain; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Hatice Demirağ, Assist Prof.

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study was designed as a single-blind, randomized, controlled clinical trial, with measures taken to minimize bias. Different individuals collected the data using the data collection form and tools, ensuring that the patients in the CoolSense and control groups remained confidential from the co-investigator and nurse responsible for administering the data collection tools, thereby implementing blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: February 20, 2023
• Primary Completion: July 31, 2023
• Study Completion: August 20, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)