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Effects of immersive virtual reality intervention on pain and anxiety among paediatric cancer patients undergoing peripheral intravenous cannulation: A randomized controlled trial
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注册号：

Registration number：

 ChiCTR1800015126 

最近更新日期：

Date of Last Refreshed on：

 2018-03-09 17:40:26 

注册时间：

Date of Registration：

 2018-03-09 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effects of immersive virtual reality intervention on pain and anxiety among paediatric cancer patients undergoing peripheral intravenous cannulation: A randomized controlled trial

Public title：

Effects of immersive virtual reality intervention on pain and anxiety among paediatric cancer patients undergoing peripheral intravenous cannulation: A randomized controlled trial

注册题目简写：

English Acronym：

Immersive virtual reality in reducing pain

研究课题的正式科学名称：

Effects of immersive virtual reality intervention on pain and anxiety among paediatric cancer patients undergoing peripheral intravenous cannulation: A randomized controlled trial

Scientific title：

Effects of immersive virtual reality intervention on pain and anxiety among paediatric cancer patients undergoing peripheral intravenous cannulation: A randomized controlled 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：

Wong Cho Lee 

研究负责人：

Yeung Man Ting 

Applicant：

Wong Cho Lee 

Study leader：

Yeung Man Ting 

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 60395118

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：

 kittyeung1218@hotmail.com

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利黃瑤璧樓8/F

研究负责人通讯地址：

中國香港特別行政區新界沙田博康邨博泰地産323室

Applicant address：

8/F, Esther Lee Building, The Chinese University of Hong Kong Shatin, N.T. Hong Kong, China

Study leader's address：

Rm 323, Pok Tai House, Pok Hong Estate, Shatin, N.T., Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 999077

研究负责人邮政编码：

Study leader's postcode：

 999077

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：

 2017.309-T

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：

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

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：

 2017-09-12 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士親王呂志和臨床科學大樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 35053935

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：

NA

Primary sponsor：

NA

研究实施负责（组长）单位地址：

NA

Primary sponsor's address：

NA

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

癌症  

Target disease：

Cancer

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to assess the effects of immersive virtual reality as a distraction intervention to reduce pain and anxiety among paediatric cancer patients undergoing peripheral intravenous catheter insertion.  

Objectives of Study：

This study aims to assess the effects of immersive virtual reality as a distraction intervention to reduce pain and anxiety among paediatric cancer patients undergoing peripheral intravenous catheter insertion.

药物成份或治疗方案详述：

Sixty children aged 7 to 18 undergoing peripheral intravenous catheter insertion will be invited to participate. Eligible children will be randomly allocated to either the intervention or control group on a 1:1 basis using the computer-generated list of random number. The intervention group will receive immersive virtual reality intervention 5 minutes before and during the procedures, whereas the control group will receive standard care only. Participants will be assessed before, during, and after completion of the procedures. 

Description for medicine or protocol of treatment in detail：

Sixty children aged 7 to 18 undergoing peripheral intravenous catheter insertion will be invited to participate. Eligible children will be randomly allocated to either the intervention or control group on a 1:1 basis using the computer-generated list of random number. The intervention group will receive immersive virtual reality intervention 5 minutes before and during the procedures, whereas the control group will receive standard care only. Participants will be assessed before, during, and after completion of the procedures. 

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria: Patients who have (1) identified cognitive and learning problems in their medical record; (2) have brain tumors or metastasis; (3) contact precaution; (4) have history of seizures and motion sickness.

Exclusion criteria：

Exclusion criteria: Patients who have (1) identified cognitive and learning problems in their medical record; (2) have brain tumors or metastasis; (3) contact precaution; (4) have history of seizures and motion sickness.

研究实施时间：

Study execute time：

从 From 2017-09-13 00:00:00至 To 2018-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-09-13 00:00:00 至 To 2018-05-31 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

Immersive Virtual reality (IVR) intervention

干预措施代码：

Intervention：

Immersive Virtual reality (IVR) intervention

Intervention code：

组别：

Control group

样本量：

 30

Group：

Control group

Sample size：

干预措施：

standard care only

干预措施代码：

Intervention：

standard care only

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：

单位(医院)：

 威爾士親王醫院 

单位级别：

 威爾士親王醫院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Children's pain level

指标类型：

主要指标

Outcome：

Children's pain level

Type：

Primary indicator

测量时间点：

Before and after the intervention

测量方法：

Visual Analogue Scale (Chinese version)

Measure time point of outcome：

Before and after the intervention

Measure method：

Visual Analogue Scale (Chinese version)

指标中文名：

Anxiety level

指标类型：

主要指标

Outcome：

Anxiety level

Type：

Primary indicator

测量时间点：

Before and after the intervention

测量方法：

The Short Form of the State Anxiety Scale for Children

Measure time point of outcome：

Before and after the intervention

Measure method：

The Short Form of the State Anxiety Scale for Children

指标中文名：

Pulse rate and mean arterial blood pressure

指标类型：

主要指标

Outcome：

Pulse rate and mean arterial blood pressure

Type：

Primary indicator

测量时间点：

Before, during, and after the intervention

测量方法：

standard automatic blood pressure monitoring machine

Measure time point of outcome：

Before, during, and after the intervention

Measure method：

standard automatic blood pressure monitoring machine

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 7 岁 years
最大 Max age 18 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Paediatric cancer patients will be randomly assigned to one group or the other. Serially numbered opaque sealed envelopes containing the grouping identifier (control or intervention) will be prepared in advance by an independent statistician using computer-generated random number sequences.

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

Paediatric cancer patients will be randomly assigned to one group or the other. Serially numbered opaque sealed envelopes containing the grouping identifier (control or intervention) will be prepared in advance by an independent statistician using computer-generated random number sequences.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

Because of the nature of an IVR intervention, blinding of participants and outcome assessors will be difficult.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

Protocol

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

Protocol

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：

The RA in the Children’s Cancer Centre will screen for eligibility for all patients who are admitted. If the patient met the inclusion criteria, an information sheet will be given to the accompany parent and the patient with the explanation of the purpose of the study. If they agree to participate, written informed consent from the accompany parents and ascent from the child will be obtained. Patients will also be invited to put their names on the consent form to show their willingness to participate. The researcher will then acquire socio-demographics information from the parents. Clinical characteristics of the patients will also be obtained from medical record. About 5 minutes before the PIC (T0), a set of baseline data – pain, anxiety, and heart rate- will be collected from the patients in order to measure any predispose internal factors such as chronic pain. According to the subject allocation, children in the control group will receive standard care, while the intervention group will additionally receive the IVR intervention with the developed VR module. When the catheter begin to insert to the patients’ skin (T1), the researcher will take record of the child’s heart rate. If the first attempt is unsuccessful, measurement of subsequent attempt will be measured. Immediate after PIC (T2), the IVR equipment will be removed, and the measurement of pain, anxiety, and heart rate will be collected from the patients again.

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

The RA in the Children’s Cancer Centre will screen for eligibility for all patients who are admitted. If the patient met the inclusion criteria, an information sheet will be given to the accompany parent and the patient with the explanation of the purpose of the study. If they agree to participate, written informed consent from the accompany parents and ascent from the child will be obtained. Patients will also be invited to put their names on the consent form to show their willingness to participate. The researcher will then acquire socio-demographics information from the parents. Clinical characteristics of the patients will also be obtained from medical record. About 5 minutes before the PIC (T0), a set of baseline data – pain, anxiety, and heart rate- will be collected from the patients in order to measure any predispose internal factors such as chronic pain. According to the subject allocation, children in the control group will receive standard care, while the intervention group will additionally receive the IVR intervention with the developed VR module. When the catheter begin to insert to the patients’ skin (T1), the researcher will take record of the child’s heart rate. If the first attempt is unsuccessful, measurement of subsequent attempt will be measured. Immediate after PIC (T2), the IVR equipment will be removed, and the measurement of pain, anxiety, and heart rate will be collected from the patients again.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2018-03-09 17:40:26
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