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

Primary Purpose

Pain, Bleeding Time, Arteriovenous Fistula

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bevel Position
Sponsored by
Istanbul Demiroglu Bilim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Demiroglu Bilim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bevel Up

Bevel Down

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline Invasive Pain at 12 Dialysis Session
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.
Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2021
Last Updated
November 1, 2021
Sponsor
Istanbul Demiroglu Bilim University
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1. Study Identification

Unique Protocol Identification Number
NCT05115448
Brief Title
Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time
Official Title
Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Demiroglu Bilim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Bleeding Time, Arteriovenous Fistula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevel Up
Arm Type
Other
Arm Description
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.
Arm Title
Bevel Down
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bevel Position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline Invasive Pain at 12 Dialysis Session
Description
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.
Time Frame
At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)
Title
Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
Description
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.
Time Frame
At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Demiroglu Bilim University
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15835412
Citation
Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martinez Gomez A, Fuentes Galan MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. doi: 10.1111/j.1755-6686.2004.tb00369.x.
Results Reference
background
PubMed Identifier
14598956
Citation
Gaspar LJ, Moreira NM, Moutinho AA, Pinto PJ, Lima HB, Rodrigues F. Puncture of the arteriovenous fistula: bevel upward or bevel downward? EDTNA ERCA J. 2003 Apr-Jun;29(2):104. doi: 10.1111/j.1755-6686.2003.tb00284.x. No abstract available.
Results Reference
background
PubMed Identifier
26951901
Citation
Marticorena RM, Donnelly SM. Impact of needles in vascular access for hemodialysis. J Vasc Access. 2016 Mar;17 Suppl 1:S32-7. doi: 10.5301/jva.5000534. Epub 2016 Mar 6.
Results Reference
background

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

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