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临床试验/NCT01100541
NCT01100541已完成不适用

Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Acceptance of the polymeric plate

研究概览

简要总结

The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.

The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.

详细描述

In this study, the polymeric plate is prepared using the following procedure:

    • the water is heated to the boiling temperature
    • the heater is shut down
    • the polymeric plate is immersed in water
    • it rests in the water for 15 minutes
    • it is inserted in a wrap

In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.

After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.

Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good communication and comprehension
  • Skin integrity

排除标准

  • Reduced skin sensitivity
  • Disturbance in the central nervous system

结局指标

主要结局

Acceptance of the polymeric plate

时间窗: 2 weeks

Acceptance of the polymeric plate by the volunteers.

次要结局

  • Polymeric plate comfort(2 weeks)
  • Polymeric plate temperature(2 weeks)
  • Polymeric plate time of heat retention(2 weeks)
  • Sensation on the superficial touch of the polymeric plate(2 weeks)
  • Appearance of the polymeric plate(2 weeks)
  • Polymeric plate weight(2 weeks)
  • Polymeric plate practicality(2 weeks)
  • General observations about the polymeric plate(2 weeks)

研究者

申办方类型
Other

研究点 (2)

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