Determination of the Effect of Cold Needle on Invasive Pain Cannulation

Not Applicable

Active, not recruiting

• Conditions: Pain; Hemodialysis Complication
• Interventions: Procedure: Cold needle application

• Registration Number: NCT06418009
• Lead Sponsor: Istanbul Demiroglu Bilim University

Brief Summary

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.

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 Timeline

• Study Start: 2024-04-20
• Status Verified: 2024-05
• Primary Completion: 2024-05-05
• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Study Completion: 2024-05-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cold needle application	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.

Primary Outcome Measures

Name	Time	Method
Invasive pain	Up to two weeks	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

Trial Locations

Locations (1)

Demiroglu Bilim University; 🇹🇷 Istanbul, Turkey