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临床试验/NCT01420835
NCT01420835已完成2 期

Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
175
试验地点
2
主要终点
stress levels

研究概览

简要总结

The purpose of this study is to assess stress levels and quality of life in the nursing team of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and without closed protocol on reducing the stress levels and improvement of life quality.

详细描述

Based on the positive results achieved in a preliminary study conducted in January and February 2010, entitled "Applicability of auricular needles or seeds for the reduction of stress in nursing professionals" at the University Hospital, emerged from this research project in order to extend the first study, with a more representative sample and with a design that would allow further discussions on the effectiveness of Chinese auricular needles semi-permanent to reduce stress and thereby improving the quality of life of nursing professionals. This clinical trial aims, above all, compare the results of the technique with the use of closed protocol and a group without protocol. The latter, however, shall be based on energy evaluation according to Traditional Chinese Medicine (TCM) and the course of treatment will be performed similarly to the clinical practice commonly performed by traditional practitioners, that is, individually, not necessarily repetitive and whose continuation is achieved depending on the answers to each treatment.

Discussions are justified about protocol and no protocol research in complementary and integrative practices, since the methodologies proposed and accepted by the scientific community does not always seem to be appropriate tools for evaluating therapies like those coming from the East. The transfer of the Western conception of research according to positivist principles are not always consistent with the principles underlying the complementary and alternative therapies, and in particular the practice from China.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Score by the List of Stress Symptoms (40 to 95 points)
  • Voluntary participation in the study
  • Availability of time for submission to the sessions

排除标准

  • Medical license or vacation during the period
  • If they perform another chinese treatment like a massage, acupuncture, moxibustion etc

研究组 & 干预措施

Auriculotherapy with protocol

Active Comparator

Auriculotherapy with stress protocol points. Five points are indicated for stress (Liver yang1, Liver yang2, Shenmen, Brainstem and Kidney).

干预措施: Auriculotherapy (protocol group) (Other)

Without Protocol Group

Active Comparator

The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.

Five points will be chosen to treat stress according to the symptoms and Chinese diagnosis.

干预措施: without protocol group (Other)

Control Group

No Intervention

Control Group won't receive any treatment and will be evaluated at the same time and the same way of interventions group

结局指标

主要结局

stress levels

时间窗: 75 days

The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms

次要结局

  • quality of life domains(75 days)

研究者

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

Leonice Fumiko Sato Kurebayashi

Leonice Fumiko Sato Kurebayashi

University of Sao Paulo

研究点 (2)

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