The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention With Local Anesthesia on Patients Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Anxiety evaluated using the State Anxiety Scale
研究概览
简要总结
This randomized controlled trial evaluates the effect of virtual reality glasses applied during emergency surgical intervention with local anesthesia on patients anxiety. This study hypothesizes that virtual reality glasses reduces anxiety.
详细描述
The sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). Virtual Reality (VR) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. Anxiety level will be assessed with the Spielberger State Anxiety Scale and measured by physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application. In the control group, no application will be made except for standard care only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The researchers will involve in the data analysis and statistics stages will blind to the group assignment. Patients in study can not be blinded. Also, the person who performed the measurements cannot be blinded due to the nature of VR application. A statistician will analyze the data, and the findings will be reported.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Emergency surgical intervention with local anesthesia,
- •Between the ages of 18-65,
- •Conscious, oriented and cooperative,
- •Able to read and understand Turkish,
- •Agree to participate in the study
- •Does not have physical problems that will prevent the application of virtual reality glasses,
- •No previous experience with virtual reality glasses,
- •Not diagnosed with anxiety,
- •Does not use drugs for anxiety,
- •Does not use alcohol and/or drugs,
- •No mental illness
- •Patients who signed the Informed Consent Form/Written Consent Form
排除标准
- •No emergency surgical intervention with local anesthesia,
- •Those under the age of 18, over the age of 65,
- •Unconscious, oriented and uncooperative,
- •Can't read and understand Turkish,
- •Those who do not agree to participate in the study,
- •Having a physical problem that will prevent the application of virtual reality glasses,
- •Diagnosed with anxiety,
- •Using drugs for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
- •Using alcohol and/or drugs,
- •Having a mental disorder,
- •Patients who did not sign the Informed Consent Form/Written Consent Form
结局指标
主要结局
Anxiety evaluated using the State Anxiety Scale
时间窗: Change from baseline and ten minutes
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high.
次要结局
- Change diastolic blood pressure(During emergency surgery with Local Anesthesia)
- Change heart rate(During emergency surgery with Local Anesthesia)
- Change systolic blood pressure(During emergency surgery with Local Anesthesia)
- Change respiratory rate(During emergency surgery with Local Anesthesia)
- Change peripheral oxygen saturation(During emergency surgery with Local Anesthesia)