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临床试验/NCT01456273
NCT01456273Unknown不适用

Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia

Faculdade de Medicina do ABC2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.

研究概览

简要总结

This study aims to evaluate, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).

详细描述

INTRODUCTION Addressing the high costs involved in new medical technology (biotechnology) is a problem that has led individuals and public health services to feel increasingly powerless.

Many authors say that not even an efficient use of resources can ensure better care and health care, a true bottomless pit.

The problem is the conceptual and ideological bases of thinking and acting of the professionals involved. The first misunderstanding is the "narrow approach" and the second is the "process of medicalization."

The curative model and the restricted approach The curative model gets this name because it is not concerned with the causes of the disease process (prevention), only with the effects (the disease). As the effects can be mitigated or even extinct, it is only temporary, because sooner or later they will return with the same format or not, in the same individual or another. It is extremely costly for individuals and for society, because the solutions are palliative. The approach is limited and so are results too.

The process of medicalization Medicalization is the ultimate expression of the distortions of thinking and consequences of the model of health care regulations. It can be understood as the increasingly high dependence on individuals and society overestimating the role that biotechnology could play, and creating a dependency in which one believes that for any problem, regardless of its severity or causal links, there will be a life-saving 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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of functional dyspepsia (according to the Rome II criteria)
  • They must be literate so they can read and fill out the questionnaire and a diary of symptoms without the aid of others

排除标准

  • Patients who for any reason: not accepting to participate in research, not having signed an informed consent or not answering the questionnaire, the collection period, for whatever reasons
  • Abuse or dependence on alcohol, tobacco, medications or other drugs (licit or illicit)
  • Diabetes (any type
  • pregnancy or breastfeeding (in any stage of the study)
  • organic diseases or severe metabolic or evolving (heart disease, severe hypertension, infectious diseases)

结局指标

主要结局

Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.

时间窗: between four to six months of treatment

次要结局

未报告次要终点

研究者

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

Fernando Soares Guedes

Professor

Faculdade de Medicina do ABC

研究点 (2)

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