Abstract：
BACKGROUND: Anxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting in this vulnerable group. This trial aims to evaluate the effects of IVR intervention on anxiety, chemotherapy-induced nausea and vomiting and anticipatory nausea and vomiting in patients with paediatric cancer receiving first chemotherapy.
METHODS: An assessor-blinded, randomised controlled trial with a mixed methods evaluation approach. On the basis of our pilot results, 128 chemotherapy-naive patients with paediatric cancer scheduled to receive their first intravenous chemotherapy will be recruited from a public hospital and randomly allocated to intervention (n=64) or control groups (n=64). The intervention group will receive the IVR intervention for three sessions: 2 hours before the first chemotherapy, 5 min before and during their first chemotherapy and 5 min before and during their second chemotherapy, respectively. The control group will receive standard care only. A subsample of 30 participants in the intervention group will be invited for a qualitative interview. Study instruments are: (1) short form of the Chinese version of the State Anxiety Scale for Children, (2) visual analogue scale for anticipatory nausea and vomiting, (3) Chinese version of the Multinational Association of Supportive Care in Cancer Antiemesis Tool and (4) individual face-to-face semistructured interviews to explore intervention participants\' perceptions of the IVR intervention.
BACKGROUND: This study has been approved by the Hong Kong Children\'s Hospital Research Ethics Committee (HKCH-REC-2021-009). The findings will be disseminated in peer-reviewed journals and through local or interventional conference presentations.
BACKGROUND: ChiCTR2100048732.
METHODS: An assessor-blinded, randomised controlled trial with a mixed methods evaluation approach. On the basis of our pilot results, 128 chemotherapy-naive patients with paediatric cancer scheduled to receive their first intravenous chemotherapy will be recruited from a public hospital and randomly allocated to intervention (n=64) or control groups (n=64). The intervention group will receive the IVR intervention for three sessions: 2 hours before the first chemotherapy, 5 min before and during their first chemotherapy and 5 min before and during their second chemotherapy, respectively. The control group will receive standard care only. A subsample of 30 participants in the intervention group will be invited for a qualitative interview. Study instruments are: (1) short form of the Chinese version of the State Anxiety Scale for Children, (2) visual analogue scale for anticipatory nausea and vomiting, (3) Chinese version of the Multinational Association of Supportive Care in Cancer Antiemesis Tool and (4) individual face-to-face semistructured interviews to explore intervention participants\' perceptions of the IVR intervention.
BACKGROUND: This study has been approved by the Hong Kong Children\'s Hospital Research Ethics Committee (HKCH-REC-2021-009). The findings will be disseminated in peer-reviewed journals and through local or interventional conference presentations.
BACKGROUND: ChiCTR2100048732.
摘要：
背景：焦虑，恶心和呕吐是接受化疗的儿科患者常见的副作用。新的证据支持沉浸式虚拟现实（IVR）在改善这一弱势群体的焦虑和痛苦症状，包括恶心和呕吐方面的功效。该试验旨在评估IVR干预对焦虑的影响，在接受首次化疗的儿科癌症患者中，化疗引起的恶心和呕吐以及预期的恶心和呕吐。
方法：评估者盲化，采用混合方法评价方法的随机对照试验。根据我们的试点结果，将从公立医院招募128名计划接受首次静脉化疗的未接受化疗的儿科癌症患者，并随机分配到干预组（n=64）或对照组（n=64）。干预组将接受三个疗程的IVR干预：第一次化疗前2小时，第一次化疗前和期间的5分钟，第二次化疗前和期间的5分钟，分别。对照组将仅接受标准护理。将邀请干预组中30名参与者的子样本进行定性访谈。研究工具有：（1）中文版儿童状态焦虑量表的简写形式，（2）预期性恶心和呕吐的视觉模拟评分，（3）中文版支持治疗癌症止吐工具的跨国协会和（4）个人面对面半结构化访谈，以探索干预参与者对IVR干预的看法。
背景：本研究已获香港儿童医院研究伦理委员会（HKCH-REC-2021-009）批准。研究结果将在同行评审的期刊上以及通过本地或干预性会议演讲进行传播。
背景：ChiCTR2100048732。
方法：评估者盲化，采用混合方法评价方法的随机对照试验。根据我们的试点结果，将从公立医院招募128名计划接受首次静脉化疗的未接受化疗的儿科癌症患者，并随机分配到干预组（n=64）或对照组（n=64）。干预组将接受三个疗程的IVR干预：第一次化疗前2小时，第一次化疗前和期间的5分钟，第二次化疗前和期间的5分钟，分别。对照组将仅接受标准护理。将邀请干预组中30名参与者的子样本进行定性访谈。研究工具有：（1）中文版儿童状态焦虑量表的简写形式，（2）预期性恶心和呕吐的视觉模拟评分，（3）中文版支持治疗癌症止吐工具的跨国协会和（4）个人面对面半结构化访谈，以探索干预参与者对IVR干预的看法。
背景：本研究已获香港儿童医院研究伦理委员会（HKCH-REC-2021-009）批准。研究结果将在同行评审的期刊上以及通过本地或干预性会议演讲进行传播。
背景：ChiCTR2100048732。
