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临床试验/NCT06418009
NCT06418009进行中(未招募)不适用

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

Istanbul Demiroglu Bilim University2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2024年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
35
试验地点
2
主要终点
Invasive pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Pain assessment will be made by a nurse independent of the study

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Invasive pain

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Istanbul Demiroglu Bilim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurten Ozen

Associate Professor

Istanbul Demiroglu Bilim University

研究点 (2)

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