【ChiCTR1900021694】Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory trial

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基本信息

登记号

ChiCTR1900021694

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-03-05

临床申请受理号

靶点

适应症

Patients receiving first chemotherapy

试验通俗题目

Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory trial

试验专业题目

Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory trial

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临床试验信息

试验目的

The objectives of this trial are: 1. To assess the parameters and feasibility for the design of a definitive trial,- Screening, eligibility, consent and withdrawal rates; 2. 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; 3. To assess the satisfaction of the chemotherapy procedure to parents and nurses; 4. To explore ways of improvement for the implementation of intervention and the acceptability of the intervention to patients, parents and nurses.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

A computer-based stratified randomization is used to randomly assign patients into one group or the other. Strata are constructed on the basis of cancer types. Randomization will be conducted by an independent statistician.

盲法

The nature of an IVR intervention may be impractical for the blinding of participants and outcome assessors.

试验项目经费来源

Nil

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-07-01

试验终止时间

2020-06-30

是否属于一致性

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.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學那打素護理學院

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