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    【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

    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

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    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
    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

    10

    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
    试验机构

    香港中文大學那打素護理學院

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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