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Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)

2012年4月2日 更新者:Istituto Auxologico Italiano

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

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.

研究概览

研究类型

介入性

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Mexico City、墨西哥
        • Regional Hospital No. 25 of the IMSS

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • death or blind patients

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Virtual reality exposure to a relaxing virtual environment. The virtual experience will be provided using immersive equipment.

The Green Valley, a non interactive, relaxing environment showing a mountain landscape around a calm lake is presented to the patient together with the relaxing music and soft sounds (birds' songs, the water flowing, etc). Having the impression of walking around the lake, patients can observe the nature and virtually seat on a comfortable deck chair, in order to become easily relaxed.

Patients were exposed to the virtual environment for the entire length of the operation.

实验性的:2
Exposure to relaxing music. The music will be selected between classical music tunes.
A relaxing music and nature sounds have been used to provide a calm atmosphere and reduce stress. In the Music group it was provided to the patients through earphones with no visual stimulation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Psychological measure of anxiety (VAS-A)
大体时间:One day before operation; one hour after operation; one week after operation
Change from baseline in the level of anxiety
One day before operation; one hour after operation; one week after operation

次要结果测量

结果测量
措施说明
大体时间
Physiological parameter (heart rate)
大体时间:One day before operation; one hour after operation; one week after operation
Change from baseline in the heart rate
One day before operation; one hour after operation; one week after operation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Giuseppe Riva, PHD、Istituto Auxologico Italiano

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年10月1日

初级完成 (实际的)

2011年2月1日

研究完成 (实际的)

2011年2月1日

研究注册日期

首次提交

2009年2月22日

首先提交符合 QC 标准的

2012年4月2日

首次发布 (估计)

2012年4月4日

研究记录更新

最后更新发布 (估计)

2012年4月4日

上次提交的符合 QC 标准的更新

2012年4月2日

最后验证

2012年4月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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