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Clinical Trials/NCT06418009
NCT06418009
Active, Not Recruiting
N/A

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

Istanbul Demiroglu Bilim University1 site in 1 country35 target enrollmentApril 20, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemodialysis Complication
Sponsor
Istanbul Demiroglu Bilim University
Enrollment
35
Locations
1
Primary Endpoint
Invasive pain
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
May 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Istanbul Demiroglu Bilim University
Responsible Party
Principal Investigator
Principal Investigator

Nurten Ozen

Associate Professor

Istanbul Demiroglu Bilim University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Invasive pain

Time Frame: 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

Study Sites (1)

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