Determination of the Effect of Cold Needle on Invasive Pain Cannulation

Determination of the Effect of Cold Needle Application on Invasive Pain Associated With Fistula Cannulation

In studies evaluating the methods used to reduce invasive pain associated with cannulation, it is seen that pharmacological and non-pharmacological methods are used. Pharmacological treatment is considered risky as it may cause drug addiction in the patient and may cause side effects and complications. On the other hand, the use of non-pharmacological methods is preferred because they are cheaper and cause fewer side effects and complications.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Hemodialysis Complication
• Intervention / Treatment: Procedure: Cold needle application

Detailed Description

Cold application, one of the non-pharmacological methods used, is effective in relieving pain by slowing down or blocking the conduction of peripheral nerves. Apart from this effect, it stimulates touch receptors by activating the Door-Control mechanism; It increases the release of endogenous opioids and stops pain by ensuring the nerve impulses caused by cold are transmitted to Delta fibers. Although studies conducted on hemodialysis patients have shown that cold application is effective in reducing pain; Due to the small number of sample groups and deficiencies in the methodology, it was suggested that further studies be conducted. In these studies, cold application; It was applied to the area one cm above the fistula or between the thumb and index finger of the opposite arm, using an ice pack and an ice-filled glove for 2-10 minutes.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Demiroglu Bilim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients aged 18 years and older
• had been treated with HD for at least 3 months, thrice a week, and for 4 hours per session
• did not have a psychiatric disorder that would prevent communication
• volunteered to participate in the study

Exclusion Criteria:

• Patients who were known to present difficulties when entering the fistula (requiring multiple cannulations)
• had a history of hematoma or stenosis in the AVF
• had an infection at the fistula site
• took painkillers within 3 hours of treatment
• did not want to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Not cold needle application; Fistül girişimi için kullanılan iğne kendi torbasında durdurulur ve hastalığın takılacağı zaman Resmi tarafından deponun içinden çıkarılarak kullanılacaktır
Experimental: Cold needle application; Before use, the needle will be removed from the refrigerator and kept on the nurse's table. When the temperature of the needle reaches 0-2 °C, the patient will be cannulated.	Procedure: Cold needle application; Before use, the needle will be removed from the refrigerator and kept on the nurse's table. When the temperature of the needle reaches 0-2 °C, the patient will be cannulated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive pain	It will be assessed three times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome	Up to two weeks

Collaborators and Investigators

• Sponsor: Istanbul Demiroglu Bilim University
• Investigators: Principal Investigator: Nurten Ozen, Assoc. Prof., Istanbul Demiroglu Bilim University

Publications and helpful links

General Publications

• Ozen N, Tosun B, Sayilan AA, Eyileten T, Ozen V, Ecder T, Tosun N. Effect of the arterial needle bevel position on puncture pain and postremoval bleeding time in hemodialysis patients: A self-controlled, single-blind study. Hemodial Int. 2022 Oct;26(4):503-508. doi: 10.1111/hdi.13044. Epub 2022 Sep 6.
• Sadeghpour Marvi H, Baloochi Beydokhti T, Sajjadi M, Khaleghimanesh B. Comparing Effects of Rhythmic Breathing and Lidocaine Spray on Pain Intensity During Needle Insertion Into Arteriovenous Fistula in Hemodialysis Patients: A Randomized Controlled Trial. Anesth Pain Med. 2023 Apr 17;13(2):e126384. doi: 10.5812/aapm-126384. eCollection 2023 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Actual): May 5, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024/50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No