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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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注册号：

Registration number：

 ChiCTR1900021694 

最近更新日期：

Date of Last Refreshed on：

 2019-03-05 16:34:51 

注册时间：

Date of Registration：

 2019-03-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Cho Lee Wong 

研究负责人：

Cho Lee Wong 

Applicant：

Cho Lee Wong 

Study leader：

Cho Lee Wong 

申请注册联系人电话：

Applicant telephone：

 +852 39438166

研究负责人电话：

Study leader's
telephone：

+852 39438166

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 jojowong@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 jojowong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中國香港特別行政區新界沙田香港中文大學那打素護理學院利黃瑤璧樓824室

研究负责人通讯地址：

中國香港特別行政區新界沙田香港中文大學那打素護理學院利黃瑤璧樓824室

Applicant address：

Room 824, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong

Study leader's address：

Room 824, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2017.662

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-01-03 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓8樓

Contact Address of the ethic committee：

8/F Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學那打素護理學院

Primary sponsor：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田香港中文大學那打素護理學院利黃瑤璧樓824室

Primary sponsor's address：

Room 824, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

Patients receiving first chemotherapy  

Target disease：

Patients receiving first chemotherapy

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2019-07-01 00:00:00至 To 2020-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-07-01 00:00:00 至 To 2020-06-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 10

Group：

Experimental group

Sample size：

干预措施：

Immersive virtual reality intervention

干预措施代码：

Intervention：

Immersive virtual reality intervention

Intervention code：

组别：

对照组

样本量：

 10

Group：

Control group

Sample size：

干预措施：

Standard care

干预措施代码：

Intervention：

Standard care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong

单位(医院)：

 香港兒童醫院 

单位级别：

 香港兒童醫院 

Institution
hospital：

Hong Kong Children's Hospital

Level of the institution：

Hong Kong Children's Hospital

测量指标：

Outcomes：

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course

测量方法：

short form of the Chinese version of the State Anxiety Scale for Children

Measure time point of outcome：

Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course

Measure method：

short form of the Chinese version of the State Anxiety Scale for Children

指标中文名：

Heart rate and mean arterial blood pressure

指标类型：

主要指标

Outcome：

Heart rate and mean arterial blood pressure

Type：

Primary indicator

测量时间点：

Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course

测量方法：

standard automatic blood pressure monitoring machine

Measure time point of outcome：

Four hours prior to chemotherapy; immediately before first chemotherapy course; immediately after the first chemotherapy course; at the beginning of second chemotherapy course; Immediately after second chemotherapy course

Measure method：

standard automatic blood pressure monitoring machine

指标中文名：

Anticipatory nausea and vomiting

指标类型：

主要指标

Outcome：

Anticipatory nausea and vomiting

Type：

Primary indicator

测量时间点：

Four hours prior to chemotherapy; immediately before first chemotherapy course; at the beginning of second chemotherapy course

测量方法：

visual analogue scale

Measure time point of outcome：

Four hours prior to chemotherapy; immediately before first chemotherapy course; at the beginning of second chemotherapy course

Measure method：

visual analogue scale

指标中文名：

Acute nausea and vomiting

指标类型：

主要指标

Outcome：

Acute nausea and vomiting

Type：

Primary indicator

测量时间点：

Immediately after first chemotherapy course; Immediately after second chemotherapy course

测量方法：

MASCC Antiemesis Tool

Measure time point of outcome：

Immediately after first chemotherapy course; Immediately after second chemotherapy course

Measure method：

MASCC Antiemesis Tool

指标中文名：

parent and nurse satisfaction levels toward the chemotherapy procedure

指标类型：

次要指标

Outcome：

parent and nurse satisfaction levels toward the chemotherapy procedure

Type：

Secondary indicator

测量时间点：

Immediately after second chemotherapy course

测量方法：

questionnaire

Measure time point of outcome：

Immediately after second chemotherapy course

Measure method：

questionnaire

指标中文名：

Satisfaction to the immersive virtual reality intervention

指标类型：

次要指标

Outcome：

Satisfaction to the immersive virtual reality intervention

Type：

Secondary indicator

测量时间点：

Immediately after second chemotherapy course

测量方法：

Individual face-to-face semi-structured interviews

Measure time point of outcome：

Immediately after second chemotherapy course

Measure method：

Individual face-to-face semi-structured interviews

指标中文名：

Feasibility of intervention

指标类型：

次要指标

Outcome：

Feasibility of intervention

Type：

Secondary indicator

测量时间点：

Prior to and during the intervention

测量方法：

screening rate, eligibility rate, consent rate, withdrawal rate

Measure time point of outcome：

Prior to and during the intervention

Measure method：

screening rate, eligibility rate, consent rate, withdrawal rate

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

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

Blinding：

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

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

N/A

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-03-05 16:34:51
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