跳至主要内容
临床试验/NCT01570725
NCT01570725撤回不适用

A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Psychological measure of anxiety (VAS-A)

研究概览

简要总结

Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.

Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients who undergo ambulatory surgical operations and sign informed consent

排除标准

  • death or blind patients

结局指标

主要结局

Psychological measure of anxiety (VAS-A)

时间窗: One day before operation; one hour after operation; one week after operation

Change from baseline in the level of anxiety

次要结局

  • Physiological parameter (heart rate)(One day before operation; one hour after operation; one week after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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