Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in symptom cluster
研究概览
简要总结
This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.
详细描述
While the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. The virtual reality distraction method will not be applied to the control group. After the child and his family are informed about the study, their written informed consent will be obtained.
When the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied.
Control Group: The researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
VR group; A distraction intervention will be applied for 10-15 minutes once a day with VR glasses. The symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
- •4 weeks after diagnosis (not in the induction phase)
- •No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
- •Consent to voluntarily participate in the study and written consent from the child and parent
排除标准
- •The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
- •Having a symptom of nausea and vomiting
- •Being in a terminal period
- •Undergoing a surgical operation
- •Unwillingness to participate in the study
- •Having a history of vertigo (having a history of train, motion sickness)
- •The child and family do not know Turkish
研究组 & 干预措施
virtual reality distraction
watching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment
干预措施: virtual reality (Device)
control
no virtual reality distraction
结局指标
主要结局
Change in symptom cluster
时间窗: during the 1st, 2nd and 3rd days of chemotherapy treatment
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
Change in anxiety
时间窗: (during the 1st, 2nd and 3rd days of chemotherapy treatment)
anxiety by State-Trait Anxiety Inventory for Children
次要结局
未报告次要终点
研究者
Gülçin Özalp Gerçeker
pHD, Assoc. Prof.
Dokuz Eylul University