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临床试验/NCT05716217
NCT05716217终止不适用

Can Training of the Armsy Reduce Pain When Inserting a Peripheral Venous Catheter, and How is it Experienced That There Can be Challenges With Vein Status for Patients in Cytostatic Treatment?

Vejle Hospital2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)

研究概览

简要总结

Female patients undergoing chemotherapy for breast cancer often experience pain and discomfort when a peripheral venous catheter is inserted.

This randomized, controlled trial investigates whether there is a difference in the degree of pain during PVC insertion in patients who exercise their arms, and whether exercise improves vein status.

Participation involves:

  • Everyone must have had their peripheral venous catheter (PVC) inserted at least five times in the DROP-IN, which is an outpatient clinic staffed by anesthesia nurses who are specialists in applying PVCs.
  • Everyone will three times be asked to answer some questions in the DROP-IN, have their grip strength measured in both hands, and have the course of the veins in their arms clarified.
  • The training group must do arm training exercises daily for at least eight weeks (training equipment is provided)
  • Ten participants will at the end of the project period be invited to participate in a telephone interview about experiences of vein status during a cancer treatment course.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

The anaesthesia nurses inserting PVCs and registering data are blinded to the participants' study allocation.

入排标准

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

入选标准

  • Planned neoadjuvant or adjuvant chemotherapy via intravenous peripheral venous cannula placed under ultrasound guidance
  • PVC insertion is performed in the DROP-IN outpatient clinic, Department of Anesthesiology, Vejle Hospital, at least four times
  • The patient has provided written and orally informed consent
  • The patient must be cognitively well preserved and able to understand information

排除标准

  • Patients who cannot read and understand Danish
  • Patients <18 years

结局指标

主要结局

Level of pain as measure by the Numeric Rating Scale (score 1-10 where a low value defines low level of pain)

时间窗: Measured after eight weeks of training/control

Pain level after insertion of periphral venous catheter and at general activity measured with Numeric Rating Scale

次要结局

  • Vein status(Measured after eight weeks of training/control)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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