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Clinical Trials/NCT05115448
NCT05115448
Completed
Not Applicable

Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients

Istanbul Demiroglu Bilim University1 site in 1 country35 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Istanbul Demiroglu Bilim University
Enrollment
35
Locations
1
Primary Endpoint
Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

Detailed Description

The repeated puncture of the AVF leads to a considerable degree of pain, due to the calibre and length of the bevel of fistula needles. When the fistula needle is removed, the small punctures that occur in the entrance area are closed with a thrombus. As a result, scar tissue forms in the entrance area and the surrounding skin, which can lead to the development of stenosis and aneurysm. For this reason, the needle conical tip direction is important in terms of delaying the loss of tissue elasticity and prolonging the use of the intervention area. There are very few studies investigating the effect of the conical tip being up or down on the pain that develops during cannulation in the patient.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
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

  • 18 years of age or older
  • On maintenance hemodialysis three times per week for four hours per session
  • Receiving hemodialysis therapy for a least six moths at the time of the study
  • Pain level of one or more measured by the Visual Analogue Scale during cannulation
  • Able to communicate in Turkish
  • Willing to participate to the study

Exclusion Criteria

  • Known to be difficult to enter the fistula (with more than one cannulation)
  • History of hematoma or stenosis in fistula
  • Having an infection in the fistula area
  • Taking painkillers 3 hours before treatment

Outcomes

Primary Outcomes

Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session

Time Frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

Bleeding time was defined as the time (minutes) from the moment the pressure was applied to the moment when the bleeding stopped after the fistula needle was removed.

Change From Baseline Invasive Pain at 12 Dialysis Session

Time Frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

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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