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临床试验/NCT07662564
NCT07662564已完成不适用

Optimal Time of Thermotherapy for Reducing Arteriovenous Fistula Cannulation Related Pain: A Three-Arm, Placebo-Controlled, Randomized Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change From Baseline Fistula Cannulation Related Pain

研究概览

简要总结

Arteriovenous fistula (AVF) cannulation is a routine procedure for people receiving haemodialysis and is frequently associated with pain. Thermotherapy has been reported as an effective non-pharmacological intervention for reducing AVF cannulation-related pain; however, the optimal application duration remains unclear.

详细描述

Thermotherapy is the therapeutic application of any substance to the body that adds heat to the body resulting in increased tissue temperature. Thermotherapy increases tissue tem-perature, blood flow, metabolism, and connective tissue extensibility. Some of the benefits provided by topical heat therapy may be mediated di¬rectly in the brain. Functional brain imag¬ing research has revealed central ef¬fects of non-noxious skin warming with increased activation of the thalamus and posterior insula of the brain. In addition, innocuous tactile stimulation of the skin activates the thalamus and S2 region of the cerebral cortex. These direct effects on the brain may mitigate the sensation of pain in the brain, thereby providing pain relief. Two studies were found in the literature evaluating the effect of thermotherapy on fistula-related cannulation pain. In both studies, thermotherapy treatment was found to be effective in reducing pain. Although it is stated in the literature that thermotherapy can be applied for 5-30 minutes , research shows that it is applied for 15 minutes, 10 minutes and 20 minutes. Thermotherapy was administered in three sessions, and in one session. This randomized controlled trial was conducted to evaluate the effectiveness of different application durations (5 and 10 minutes) of thermotherapy on reducing pain during AVF cannulation for long period (12 dialysis sessions). Investigators hypothesized that the 5 minutes thermotherapy is the optimal time to alleviate the patients' fistula cannulation related pain.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 years and older
  • •Patients who received hemodialysis (HD) treatment with an arteriovenous fistula (AVF) for at least 3 months
  • •Patients receiving HD treatment 3 days a week for 4 hours each session
  • •Patients with a pain score of ⩾1 during AVF cannulation, measured by a visual analog scale (VAS)
  • •Patients able to communicate in Turkish
  • •Patients without psychiatric disorders that impair communication
  • •Patients who agreed to participate in the study

排除标准

  • •Patients who were known to present difficulties with fistula cannulation (requiring multiple cannulations)
  • •Patients with a history of hematoma or stenosis in the arteriovenous fistula (AVF)
  • •Patients with an infection at the fistula site
  • •Patients who took painkillers within 3 hours prior to treatment
  • •Hypersensitivity reactions and circulatory disorders due to thermotherapy
  • •Sensory or cognitive impairment preventing a proper assessment of pain
  • •Patients who did not wish to participate in the study

研究组 & 干预措施

Placebo Group

No Intervention

Not heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.

Heated hot pack 5 minutes

Experimental

Heated hot pack was hold for 5 minutes on the AVF cannulation area. After 5 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.

干预措施: Thermotherapy application (Other)

Heated hot pack 10 minutes

Experimental

Heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.

干预措施: Thermotherapy application (Other)

结局指标

主要结局

Change From Baseline Fistula Cannulation Related Pain

时间窗: Up to 2 weeks (3 hemodialysis sessions in a week)

It will be assessed six times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no pain) to 10 (worst pain). Pain increases the score increases. The high point describes bad outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurten Ozen

Professor

Istanbul University

研究点 (1)

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