The Use of a Virtual Reality Device (HypnoVR®) to Improve Chemotherapy-induced Nausea and Vomiting, Sleep Quality and Pain Among Children With Cancer in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up
研究概览
简要总结
Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.
详细描述
This study is a randomized controlled trial. We recruit 180 children with cancer who are aged 9 to 18 and Chinese speaking and allocate them into experimental and control group. The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The control group will receive no intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 9 to 18
- •Can read Chinese and speak Cantonese
- •diagnosed with cancer
排除标准
- •with mental disabilities or cognitive dysfunction as identified in the medical record
结局指标
主要结局
The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up
时间窗: at the 6-month follow-up
Children will be required o fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 6-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea.
Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up
时间窗: at the 6-month follow-up
Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.
Visual Analogue Pain Scale (VAS) at the 6-month follow-up
时间窗: at the 6-month follow-up
Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 6-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain.
次要结局
- The Pediatric Nausea Assessment Tool (PeNAT) at baseline(at baseline)
- The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up(at 1-month follow-up)
- The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up(at 3-month follow-up)
- Pittsburgh Sleep Quality Index (PSQI) at baseline(at baseline)
- Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up(at 1-month follow-up)
- Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up(at 3-month follow-up)
- Visual Analogue Pain Scale (VAS) at baseline(at baseline)
- Visual Analogue Pain Scale (VAS) at 1-month follow-up(at 1-month follow-up)
- Visual Analogue Pain Scale (VAS) at 3-month follow-up(at 3-month follow-up)
研究者
Dr Eva Ho
Assistant Professor
The Hong Kong Polytechnic University