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

Sponsor
Istanbul Demiroglu Bilim University (Other)
Overall Status
Completed
CT.gov ID
NCT05115448
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bevel Position
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Bevel Up

In the patients who participated in the study, cannulation was applied to the fistula with the needle direction antegrade and the needle pointing upwards for the first 6 sessions, and the needle direction antegrade and the needle tip facing down for the next 6 sessions. The cannulation procedure was performed by the same nurse for each patient who participated in the study.

Other: Bevel Position
During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.
Other: Bevel Down

In the patients who participated in the study, cannulation was applied to the fistula with the needle direction antegrade and the needle pointing downwards for the next 6 sessions. The cannulation procedure was performed by the same nurse for each patient who participated in the study.

Other: Bevel Position
During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline Invasive Pain at 12 Dialysis Session [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.

  2. Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Demiroglu Bilim University Istanbul Turkey 34384

Sponsors and Collaborators

  • Istanbul Demiroglu Bilim University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nurten Ozen, Associate Professor, Istanbul Demiroglu Bilim University
ClinicalTrials.gov Identifier:
NCT05115448
Other Study ID Numbers:
  • 07/16/2019
First Posted:
Nov 10, 2021
Last Update Posted:
Nov 10, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arteriovenous Fistula
Hemorrhage
Fistula

Study Results

No Results Posted as of Nov 10, 2021