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临床试验/NCT02141568
NCT02141568终止不适用

Effectiveness and Cost-Effectiveness Analysis of Mind-Body Interventions in a Multi-Disciplinary Clinic for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS)

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年1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
终止
入组人数
15
试验地点
1
主要终点
Health Related Quality of Life

研究概览

简要总结

The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.

详细描述

Background:

Somatic or "medically unexplained" symptoms and syndromes are common and are seen by physicians across almost every medical specialty. In many instances, these phenomena can cause a great deal of pain and frustration, restrict function and reduce patients' quality of life. Despite their frequency and severity, medical personnel often experience a great deal of difficulty in coping with such complaints and patients may be shuttled from specialist to specialist, often with little or no symptomatic relief and at a great deal of expense to the medical system. Many researchers now believe that these seemingly unrelated and "unexplained" conditions in fact share common psycho-physiological mechanisms, such as being catalyzed as a result of trauma or excessive stress, being mediated by the limbic system and affecting inhibitory sensory pathways.

Purpose of the study:

Testing the efficacy and cost-efficiency of a holistic multidisciplinary treatment methodology for medically unexplained symptoms (MUS).

Stages of the Study:

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
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
否

入选标准

  • •Men or women
  • •Age 18 or higher
  • •Treated at the Functional Neurology clinic at Soroka UMC

排除标准

  • •patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness
  • •patients who do not speak Hebrew
  • •bedridden patients
  • •Schizophrenia, dementia and other severe mental illness

研究组 & 干预措施

Intervention Group for Prospective Study

Experimental

Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.

干预措施: Medical and Psychological treatment (Other)

No Intervention

No Intervention

Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

结局指标

主要结局

Health Related Quality of Life

时间窗: 6 months

Changes in the Short Form 36 Health Survey (SF-36)

次要结局

  • Cost-effectiveness(12 months)
  • Locus of Control(6 months)
  • Anxiety(6 months)
  • Depression(6 months)
  • Catastrophization(6 months)
  • Existence of Symptoms(6 months)
  • Pain Symptoms and Functioning(6 months)
  • Patient Satisfaction with Medical Care(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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