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临床试验/NCT02525445
NCT02525445已完成4 期

Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation

Karolinska Institutet0 个研究点目标入组 243 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
243
主要终点
Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)

研究概览

简要总结

The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.

详细描述

Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.

Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.

Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.

Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.

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

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

入选标准

  • Over 18 years of age
  • Able to understand and read/write Swedish

排除标准

  • No acupuncture training

结局指标

主要结局

Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)

时间窗: approximately 5 minutes before treatment and approximately 5 minutes after treatment

Subjective perception of relaxation measured with a 0-100 mm Visual analogue scale

次要结局

  • Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)(approximately 5 minutes before treatment and approximately 5 minutes after treatment)

研究者

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

Mats Lekander

Professor

Karolinska Institutet

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