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临床试验/NCT03640195
NCT03640195已完成不适用

Acupoint Stimulation for Pain Reduction

Chang Gung Memorial Hospital0 个研究点目标入组 92 人开始时间: 2016年10月1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
发起方
入组人数
92
主要终点
Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

研究概览

简要总结

This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.

详细描述

Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.

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
None

入排标准

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

入选标准

  • •Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
  • •Must be able to communicate clearly
  • •Must be above age 20

排除标准

  • •Previous radiotherapy
  • •History of arrhythmia or use of a pacemaker
  • •Local swelling or infection over the acupoint area

研究组 & 干预措施

Experimental group

Experimental

Transcutaneous nerve electrical stimulation and Auricular acupressure.

干预措施: Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure (Other)

Control group

No Intervention

without intervention

结局指标

主要结局

Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

时间窗: from enrollment to end of treatment at 6 weeks

Pain intensity was assessed using visual analogue scales (VAS) , which is a 10-cm continuous line to assess the subjective perception of pain in the case, with a score of 0 on the leftmost end of the line indicating "painless" and 10 points indicating The "most severe pain" and the reliability of pain assessment , and all participants received this linear tool measurement, recording a total of five

次要结局

  • Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks(from enrollment to end of treatment at 6 weeks)
  • Difference between the two groups from Baseline in quality of life European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35)(from enrollment to end of treatment at 6 weeks)
  • Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale(from enrollment to end of treatment at 6 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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