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临床试验/NCT02376959
NCT02376959Unknown不适用

Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers

Associação Médico Espírita de Botucatu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Change in Anxiety questionnaire from baselaine at 8 weeks

研究概览

简要总结

Background: The use of alternative therapies in medicine has been increasing worldwide. Among these therapies are energy therapies such as Reiki , Johrei, and Spiritist "passe." Experimental studies have confirmed the action of the energy therapies in animal models or in cell cultures. These therapies appear to have positive effects, particularly in the reduction of anxiety and pain. Objective: To evaluate the effectiveness of the "passe" energy therapy in reducing anxiety in subjects presenting anxiety symptoms after 8 weeks of study. Methods: The recruited volunteers will be randomized into two groups: the Control Group (application of 8 "passe" simulation sessions by people without spiritualist training at the same time and in the same environment as the treatment group) and the Treatment Group (application of 8 sessions of "passe" by spiritists with over 2 years of experience in controlled environments for the same period as the control group). The sample will consist of 60 patients selected by interviews with the expectation of a 20% reduction of anxiety in the control group and 60% in the treatment group with alpha of 0.05 and beta of 0.8. Results: Using the STAI scale for evaluation, the reduction in anxiety is expected to be significantly higher in the treatment group than in the control group. The investigators expect approximately 20-30% reduction of the anxiety in the control group by the placebo effect. Other objectives to be assessed are quality of life, spirituality, and depression by specific standardized scales (WHOQOL-BREF, DUREL, and BECK).

详细描述

The use of complementary medicine has increased significantly worldwide and up to 40% of American patients use some form of complementary therapy[1,2 ]. Among these are the energy therapies such as Reiki[3], Johrei, and Spiritist "passe"[4]. These therapies are based on the modification of the energy fields that surround and penetrate the human body, and are supposedly involved in the health and disease process. Application of these therapies involves touch or laying hands on these energy fields, the existence of which has not yet been proven. Experimental studies have shown the action of energy therapies in animal models or in cell cultures[5,6,4]. Johrei proved to be effective in improving sleep in mice subjected to sleep interruption[5] and in reducing tumor cell growth in vitro[6]. An experimental study was recently published showing the effect of Spiritist "passe" on the growth of bacterial colonies of Escherichia coli. When "passe" was applied with the intention of reducing the growth of colonies there was a statistically significant reduction compared to the control group, subjected to laying of the hands without application of "passe" [4]. This study is recognized as the first experimental evidence of "passe" which is widespread in spiritism. Spiritism is a very common religion and philosophy in Brazil and the use of Spiritist "passe" is a form of treatment under this religion that is highly established in the treatment of psychiatric disorders[7,8]. Therapies used in spiritualism include Spiritist "passe," spiritist education, disobsession, and fluidic water. Studies investigating the scientific basis of these therapies are beginning to feature in the literature[8,9,10]. For energy therapies with clinical purposes, a few meta-analysis studies have evaluated distance healing and some touch therapies without reaching conclusive results, indicating a high heterogeneity between studies and presenting the need for more primary studies in the field[11,12]. Among the energy therapies, Reiki is the most widely studied; however, in recent meta-analysis, due to the large variability of the studies, different endpoints (anxiety, pain, depression) and methodological flaws, its efficacy has not yet been confirmed[13]. However, a more recent systematic review shows the efficacy of Reiki in reducing anxiety and pain[14].

Thus, despite the heterogeneity of the studies, energy therapies appear to have positive effects, particularly on the reduction of anxiety and pain. Spiritist "passe" is an important therapy in Brazil that is similar to other energy therapies such as Reiki and Johrei, and its efficacy has been experimentally confirmed[4]. Therefore, studies on clinical outcomes of this important form of complementary therapy are necessary. Unlike Reiki[14] and Johrei[15], there are no clinical studies on Spiritist "passe" despite its similar basis as an energy therapy.

  1. STUDY HYPOTHESIS

The hypothesis of the study is that the Spiritist "passe" energy therapy will result in the reduction of anxiety, depressive symptoms, and improved quality of life in subjects with anxiety. The primary objective is to evaluate the Spiritist "passe" therapy in reducing anxiety in subjects with symptoms of anxiety after 8 weeks of study.

II. OBJECTIVES

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
是

入选标准

  • •Age greater ≥18 years
  • •Score of STAI-Trait questionnaire >41 (corresponding to the 51% for the Brazilian population)

排除标准

  • •Patients with cognitive impairment who are unable to understand the questionnaires
  • •Patients undergoing treatment for anxiety or depression
  • •Patients undergoing psychological counseling
  • •Patients receiving psychiatric care

研究组 & 干预措施

Control Group

Placebo Comparator

Application of 8 spiritist "passe" simulation sessions by people without spiritist training at the same time and in the same environment as the treatment group.

Treatment Group (Spiritist "passe")

Active Comparator

Application of 8 sessions of spiritist "passe" by spiritists with more than 2 years of experience in controlled environments for the same period as the control group.

干预措施: Spiritist "passe" (Behavioral)

结局指标

主要结局

Change in Anxiety questionnaire from baselaine at 8 weeks

时间窗: Baselaine; 4 weeks and 8 weeks

次要结局

  • Change in Beck Depression Inventory from baselaine at 8 weeks(Baselaine; 4 weeks and 8 weeks)
  • Change in WHOQOL-BREF quality of life questionnaire from baselaine at 8 weeks(Baselaine; 4 weeks and 8 weeks)
  • Change in DUREL questionnaire for assessment of spirituality from baselaine at 8 weeks(Baselaine; 4 weeks and 8 weeks)

研究者

发起方
Associação Médico Espírita de Botucatu
申办方类型
Other
责任方
Sponsor

研究点 (1)

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