Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Nurten Ozen
Associate Professor
Istanbul Demiroglu Bilim University