Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
The objectives of this trial are:
- To assess the parameters and feasibility for the design of a definitive trial,- Screening, eligibility, consent and withdrawal rates;
- To assess the data collection procedure and collection of preliminary data, - Anxiety (self-reported and physiological responses including heart rate and mean arterial blood pressure), anticipatory and acute CINV between the intervention and control groups;
- To assess the satisfaction of the chemotherapy procedure to parents and nurses;
- To explore ways of improvement for the implementation of intervention and the acceptability of the intervention to patients, parents and nurses.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The nature of an IVR intervention may be impractical for the blinding of participants and outcome assessors.
入排标准
- 性别
- Male
入选标准
- •Patients who are
- •(1) aged between 6 and 12 years;
- •(2) chemotherapy naive;
- •(3) scheduled to receive their first intravenous chemotherapy;
- •(4) can understand Chinese.
排除标准
- •Patients who have
- •(1) identified cognitive and learning problems in their medical record;
- •(2) brain tumours or metastasis;
- •(3) identified contact precautions;
- •(4) previous history of seizures or motion sickness.
研究组 & 干预措施
试验组
Immersive virtual reality intervention
对照组
Standard care
结局指标
主要结局
Anxiety
时间窗: Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course
Heart rate and mean arterial blood pressure
时间窗: Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course
Anticipatory nausea and vomiting
时间窗: Four hours prior to chemotherapy; immediately before first chemotherapy course; at the beginning of second chemotherapy course
Acute nausea and vomiting
时间窗: Immediately after first chemotherapy course; Immediately after second chemotherapy course
次要结局
- parent and nurse satisfaction levels toward the chemotherapy procedure(Immediately after second chemotherapy course)
- Satisfaction to the immersive virtual reality intervention(Immediately after second chemotherapy course)
- Feasibility of intervention(Prior to and during the intervention)