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临床试验/NCT06469112
NCT06469112已完成不适用

The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study

Uludag University2 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
2
主要终点
pain intensity in mm

研究概览

简要总结

Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.

Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being over the age of 18
  • having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
  • having no coagulation disorder
  • having no disorder which could affect pain perception,
  • having no incision, lipodystrophy or finding of infection at the injection site,
  • having no communication problem, and voluntarily agreeing to participate in the research

排除标准

  • being under the age of 18
  • having diabetes mellitus
  • peripheral vascular disease, etc. which could affect the perception of pain
  • not being conscious, refusing to participate in the research or opting to leave the study at any point.

结局指标

主要结局

pain intensity in mm

时间窗: 6 months

A 10-cm vertical VAS will used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible.

次要结局

  • height(6 months)
  • weight(6 months)

研究者

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

Dilek Yilmaz, PhD

Associate Professor, Bursa Uludag University, Department of Nursing

Uludag University

研究点 (2)

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