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临床试验/NCT00425399
NCT00425399已完成不适用

Shiatsu Adjuvant Therapy for Hospitalized Psychiatric Patients: an Open Pilot Study

Herzog Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Brief Psychiatric Rating Scale (BPRS)

研究概览

简要总结

In the current study we will study the effect of adding shiatsu treatment to conventional therapy in work with hospitalized schizophrenic patients.

The hypotheses of this study are several:

  1. Shiatsu can improve the patients' symptoms
  2. Shiatsu can ameliorate neuromuscular side effects produced by standard anti-psychotic treatment
  3. Shiatsu can provide patients with tools to deal with the stresses of their illness

2. Methodology We propose an open pilot study in which a total of 20 patients of both sexes will be enrolled. These patients will be drawn from the inpatient psychiatric wards at Herzog Hospital.

Upon inclusion into the trial, all participants will receive shiatsu treatment, consisting of two individual weekly 40-minute shiatsu treatment sessions for four weeks. Provider and patient will be of the same gender. Standard pharmacotherapy will be provided as needed during the treatment period. Medication and dosage will not be changed. If necessary, benzodiazepines will be administered as required.

Outcome measures:

The following assessments will be included:

  1. Medication: Use of SOS benzodiazepines
  2. Clinical rating scales: PANSS, CGI, NOSIE, Hamilton Scales for depression and anxiety

1. Side effect scales: Simpson Angus Scale, AIMS scale, UKU scale 2. Neurophysiological testing: Prepulse inhibition (PPI). 3. Neurocognitive testing: This will be performed using the NIMH's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery for Clinical Trials.

详细描述

SHIATSU ADJUVANT THERAPY FOR SCHIZOPHRENIA Protocol for an Open Pilot Study

1. Background Schizophrenia is a severe, chronic mental illness that affects approximately 1% of the population worldwide. While the pharmacological treatments available have advanced considerably in the last fifty years, there are limits to what they offer some patients, especially in terms of improving dysphoria, sleep, mood, avolition, social functioning, and anhedonia, which contribute greatly to the everyday misery of these patients.

Furthermore, some of the antipsychotic drugs induce side effects of parkinsonism, akathisias, orofacial dyskinesias, dystonias, and their associated muscle pain, and stiffness. The treatments used for those side effects are anticholinergic drugs (e.g. trihexyphenidyl), benzodiazepines, and beta blockers. The number and variety of such drugs suggests what clinicians know to be unfortunately true: there are no magic bullets for these symptoms. These drugs are also not innocent, causing side effects of their own, contributing to polypharmacy, and carrying a financial cost.

Schizophrenia, then, remains a debilitating illness whose treatment results are often partial and may produce unpleasant side-effects. New approaches to supplement standard modalities ought to be considered.

Shiatsu, or acupressure, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. Shiatsu involves applying pressure to "meridians" of the body, much like acupuncture but without the needles. The shiatsu therapist views the whole body as interconnected - stiffness in one part may reflect a problem in another, or emotional disharmony. In accordance with the WHO definition of health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity," shiatsu massage aims to improve the overall well-being of its recipients by manipulating the body.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • DSM-IV-R diagnosis of schizophrenia or schizoaffective disorder
  • Ages 18 and over
  • Clinical status stable, as reflected by at least one month of drug treatment without change of anti-psychotic drug or dosage.
  • Ability to cooperate with 40-minute sessions

排除标准

  • Active fracture or other orthopedic problem
  • Skin condition that renders treatment unsafe or painful
  • Active infection in skin or soft tissues, such as cellulitis
  • Any acute illness or other medical condition (e.g. solid tissue malignancy) for which shiatsu may be contraindicated

结局指标

主要结局

Brief Psychiatric Rating Scale (BPRS)

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
Herzog Hospital
申办方类型
Other

研究点 (2)

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