Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
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
阶段
- 不适用
联系人和位置
学习地点
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Mexico City、墨西哥
- Regional Hospital No. 25 of the IMSS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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实验性的:1
Virtual reality exposure to a relaxing virtual environment.
The virtual experience will be provided using immersive equipment.
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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. |
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实验性的:2
Exposure to relaxing music.
The music will be selected between classical music tunes.
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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.
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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 |
|---|---|---|
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Psychological measure of anxiety (VAS-A)
大体时间:One day before operation; one hour after operation; one week after operation
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Change from baseline in the level of anxiety
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One day before operation; one hour after operation; one week after operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Physiological parameter (heart rate)
大体时间:One day before operation; one hour after operation; one week after operation
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Change from baseline in the heart rate
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One day before operation; one hour after operation; one week after operation
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合作者和调查者
调查人员
- 研究主任:Giuseppe Riva, PHD、Istituto Auxologico Italiano
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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