Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors: A Mixed Methods Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- subjective sleep quality
研究概览
简要总结
The study aims to examine the effectiveness of virtual reality (VR) hypnosis for improving sleep in among Chinese childhood cancer survivors. Investigators will conduct a three-arm mixed-methods randomized controlled trial (RCT) among 186 Chinese Childhood Cancer Survivors (CCCs). The three groups are VR hypnosis, cognitive behavioral therapy for insomnia (CBT-I), and VR relaxation. The VR hypnosis intervention contains six 30-minute sessions conducted by a clinical psychologist on 6 consecutive Saturdays in Hong Kong Children's Hospital (HKCH) or participants' home depend on participants' preference. Instead of treatment-as-usual and sleep hygiene groups, investigators will use the CBT-I as the active control because it is recommended as a first-line treatment for poor sleep. CBT-I group will have six 30-minute sessions in HKCH or home depend on participants' preference on six consecutive Saturdays. The VR relaxation group will allow us to distinguish the effects of VR from those of VR hypnosis, which has the same length and delivery mode as VR hypnosis, but without a hypnosis component. The study will be conducted at HKCH, which is the only hospital in HK that provides medical follow-ups for children with cancer. Data collection will be done at baseline, as well as immediately and 1, 3, and 6 months after completion of the intervention. Multiple assessment timepoints will capture changes over time.
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
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •completed active cancer treatment for ≥1 month
- •able to speak Cantonese and read Chinese
- •aged 12-18 years
- •poor sleeper as indicated by a PSQI score ≥ 5
排除标准
- •Survivors with learning and/or behavioral problems in medical records and those who are using sleep medication and/or previously experienced any adverse events (e.g., headache and motion sickness) when using VR
结局指标
主要结局
subjective sleep quality
时间窗: Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention
The 19-item Pittsburgh Sleep Quality Index (PSQI) will be used to assess participants' subjective sleep quality in the past month. Total scores range from 0 to 57. Poor sleepers have scores ≥ 5. The PSQI is reliable and valid to assess subjective sleep quality.
次要结局
- depressive symptoms(Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- total sleep time(Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- sleep-onset latency(Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- sleep efficiency(Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- awakening frequency after sleep onset(Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- sleep fragmentation index(Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- brain electrophysiological activities(Two consecutive nights at baseline, during the intervention period (5 minutes before, during, and 5 minutes after hypnosis), one night immediately after completing the intervention, and one night at 6-month follow-up)
- usefulness(6 months after completion of the intervention)
- incremental cost-effectiveness ratio (ICER)(Immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- cancer-related fatigue(Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- pain level(Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- quality of life (QoL)(Baseline, on completion of the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention)
- ease of use(6 months after completion of the intervention)
研究者
Dr Eva Ho
associate professor
The Hong Kong Polytechnic University