e-Nature VR: Evaluation of the Impact of Virtual Reality on the Perception of Pain, Discomfort, Stress and Well-being During Breast Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Evaluation of Discomfort and well-being
研究概览
简要总结
Randomized clinical trial about the evaluation of the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy use of nature virtual reality video.
详细描述
Breast biopsy is one of the main tests for the diagnosis of cancer, which generates emotional distress and can be a painful procedure. Distraction has considerable efficacy among mild psychological methods for reducing pain perception. Virtual Reality is the most advanced technology of distraction, with the highest level of immersion in virtual worlds and effective results as a non-pharmacological measure in pain perception. However, audiovisual resources related to nature have not yet been investigated in this clinical setting.
This clinical trial aims to verify the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy; its influence on the time of the examination; the degree of recommendation of the intervention; and if the connection with nature interferes in the results obtained on the studied variables. The Immersive Reality intervention will be provided during the breast biopsy and the variables will be evaluated using Likert-type scales and pain using the Analog Virtual Scale. Our study hypothesis is that this intervention reduce the perception of pain / discomfort during the biopsy by connecting with nature, reducing anxiety, exam time, and increasing the sense of well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This study has no masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation;
- •Signed in the Informed Consent Form;
- •Patients with clinical conditions and preserved communication function, in other words, lucid patients;
- •Patients in breast biopsy procedure.
排除标准
- •Blind patients;
- •Patients without the capacity for judgment, in other words, with dementia;
- •Patients who have their clinical condition changed during the breast biopsy. Patients with history of nauseas vertigo and labyrinthitis
结局指标
主要结局
Evaluation of Discomfort and well-being
时间窗: Immediately after the end of the biopsy procedure
The questionnaire contains 6 questions that must be answered using the Likert Scale (from 1 to 5). 1. question: your perception of physical discomfort during the exam. 1 means lot of physical discomfort and 5 a lot of physical comfort. 2. question: what was your perception of psychological discomfort during the exam. 1 means lot of psychological discomfort and 5 a lot of psychological comfort. 3. question: how would you rate your sense of well-being during the examination.1 means total absence of well-being and 5 best well-being welfare. 4. question: how much anxiety you were in relation to the exam. 1 means extremely anxious and 5 nothing anxious. 5. question: how much anxiety you are in relation to the test result. 1 means extremely anxious and 5 nothing anxious. 6. question: Would you recommend this virtual reality intervention during exams that could generate some kind of discomfort? 1 means would definitely recommend and 5 would definitely not recommend
Visual Analogic Scale for Pain
时间窗: Immediately after the end of the biopsy procedure
The numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life
The Connectedness to Nature Scale
时间窗: Immediately after the end of the biopsy procedure
The Nature Connection Scale is used to verify the affective aspect of the person-environment relationship. It is composed of 14 items, which are answered in a scale of 5 points, ranging from 1 (I totally disagree) to 5 (I totally agree). The higher the score, the greater the individual's connection with nature.
次要结局
未报告次要终点