Effect of Virtual Reality on Agitation in Acute Stroke
The Effect of Virtual Reality Application on Agitation in Individuals With Acute Stroke: A Randomized Controlled Single-Blind Study
研究概览
详细说明
Stroke is a sudden medical condition that affects the brain. During the acute phase of a stroke, many patients experience agitation, which means feeling restless, anxious, or uncooperative. Agitation can complicate medical care and negatively affect a patient's recovery and vital signs (such as heart rate and blood pressure).
The main purpose of this study is to evaluate whether using a Virtual Reality (VR) application helps reduce agitation levels and stabilize vital signs in individuals who have experienced an acute stroke.
This is a randomized controlled, single-blind clinical trial. Participants with acute stroke will be randomly assigned to one of two groups:
Intervention Group: Participants will receive a structured Virtual Reality (VR) application session in addition to their routine stroke care.
Control Group: Participants will receive standard routine clinical care and monitoring without the VR application.
Researchers will measure and compare the participants' agitation levels using a clinical evaluation scale before and after the intervention. In addition, physiological vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation) will be closely monitored to determine the effects of the VR therapy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ankara、土耳其（türkiye）
- Çankırı Karatekin University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
* Individuals who have passed 48 hours post-acute CVA (being in the acute phase of stroke treatment, stroke duration not exceeding the first 4 weeks)
- Having a score of 0 on the Wong-Baker FACES Pain Rating Scale
- Having a score of at least +2 or higher on the Richmond Agitation-Sedation Scale (RASS)
- Being 18 years of age or older
- Having a GCS score of 13 or higher
- Having no hearing or visual impairments
- Not being in contact isolation due to a contagious disease
- Being literate in Turkish
- Not being administered sedation
- Being awake and hemodynamically stable
- Being able to sit in high Fowler's position
- Individuals without mechanical ventilation support
Exclusion Criteria:
Presence of nausea and vomiting
- Mobility restriction and sensitivity to claustrophobia
- Presence of delirium
- Presence of schizophrenia and dementia
- Presence of vertigo and Meniere's disease
- Having a pain score of 1 point or higher
- Having facial damage to the extent that a virtual reality headset cannot be worn
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 |
|---|---|
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实验性的：Intervention Group
Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management.
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Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.
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有源比较器：Control Group
Participants in this arm receive standard routine clinical stroke care and monitoring alone, without any Virtual Reality intervention.
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Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.
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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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Change in Body Temperature
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of body temperature (°C) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Heart Rate
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of heart rate (beats/min) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Blood Pressure
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of blood pressure (mmHg) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Respiratory Rate
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of respiratory rate (breaths/min) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Oxygen Saturation
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of oxygen saturation (SpO2, %) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Agitation Levels
大体时间：Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Agitation levels evaluated using a validated clinical agitation rating scale across three time points (pre-intervention, immediately post-intervention, and post-intervention) to assess changes in patient agitation.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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合作者和调查者
调查人员
- 研究主任：Seher Gönen Şentürk, PhD、Çankırı Karatekin University, Faculty of Health Sciences
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ÇAKÜ-SBF-NCD-01
- SBF111224L11 (其他赠款/资助编号：Cankiri Karatekin University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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