父母焦虑的治疗虚拟现实(VR)
用虚拟现实 (VR) 治疗父母的焦虑:一项前瞻性随机研究
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
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Stanford、California、美国、94304
- Lucile Parkard Children's Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 18-99 岁(患者的父母将参加)
- 能够同意
排除标准:
- 不同意的人
- 严重的认知障碍
- 严重晕动病史
- 当前恶心
- 癫痫发作
- 视觉问题 孩子临床不稳定或需要紧急/紧急干预的患者
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:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:虚拟现实
参与者将沉浸在虚拟环境中。
平静的风景将通过耳机显示 20-30 分钟
|
参与者将沉浸在虚拟环境中。
平静的风景将通过耳机显示 20-30 分钟
|
|
无干预:控制
没有干预(即
虚拟现实耳机)将应用于参与者。
|
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 |
|---|---|---|
|
Anxiety levels (General inpatient area, Emergency Department)
大体时间:Baseline, immediately after the intervention
|
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting. |
Baseline, immediately after the intervention
|
|
State-Trait Anxiety Inventory [Heart Center]
大体时间:baseline, immediately after the intervention
|
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled specifically in the Heart Center. |
baseline, immediately after the intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety levels (Heart Center)
大体时间:Baseline, immediately after the intervention
|
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels. Assessed in participants enrolled specifically in the Heart Center setting. |
Baseline, immediately after the intervention
|
|
State-Trait Anxiety Inventory (General inpatient area, Emergency Department)
大体时间:baseline, immediately after the intervention
|
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting. |
baseline, immediately after the intervention
|
|
Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire)
大体时间:immediately after intervention
|
To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey containing 5 items. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot. Assessed in participants enrolled in general hospital setting and specifically in the Emergency Department setting and Heart Center setting. |
immediately after intervention
|
|
Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire)
大体时间:immediately after virtual reality intervention
|
Caregiver response to the virtual reality intervention was assessed with an investigator-developed questionnaire administered in English or Spanish after the VR session. Four items assessed relaxation, distraction, willingness to use VR again for a future procedure or hospitalization, and interest in VR; each is scored on a 5-point Likert scale from 1 ("Do not agree at all"/"No interest at all") to 5 ("Completely agree"/"Completely interested"), with higher scores indicating greater acceptability. A final checklist item asked caregivers to indicate whether they experienced any of the following during the virtual reality experience, selecting all that applied: nausea, dizziness, headache, disorientation, eye strain, none of the above, or other. Assessed in participants enrolled in general hospital setting and Heart Center setting. |
immediately after virtual reality intervention
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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