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Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: A randomized controlled trial
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注册号：

Registration number：

 ChiCTR1800018817 

最近更新日期：

Date of Last Refreshed on：

 2018-10-11 14:05:14 

注册时间：

Date of Registration：

 2018-10-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: A randomized controlled trial

Public title：

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: A randomized controlled 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 intervention on pain and anxiety among pediatric patients undergoing venipuncture: A randomized controlled trial

Scientific title：

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: 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：

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：

 +85239438166

研究负责人电话：

Study leader's
telephone：

+85239438166

申请注册联系人传真 ：

Applicant Fax：

 jojowong@cuhk.edu.hk

研究负责人传真：

Study leader's fax：

 jojowong@cuhk.edu.hk

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香港中文大學那打素護理學院利黃瑤璧樓八樓

研究负责人通讯地址：

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓八樓

Applicant address：

8/F Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China

Study leader's address：

8/F Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China

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：

香港中文大學那打素護理學院

Applicant's institution：

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

研究负责人所在单位：

香港中文大學那打素護理學院

Affiliation of the Leader：

The Nethersole School of Nursing, 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：

 2017.665

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-02-28 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香港中文大學那打素護理學院利黃瑤璧樓八樓

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：

 +852 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：

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香港中文大學那打素護理學院利黃瑤璧樓八樓

Primary sponsor's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong8/F Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

University Grants Committee

具体地址：

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓八樓

Institution
hospital：

University Grants Committee

Address：

The Nethersole School of Nursing, The Chinese University of Hong Kong8/F Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China

经费或物资来源：

Early Career Scheme

Source(s) of funding：

Early Career Scheme

研究疾病：

Patients undergoing venipuncture  

Target disease：

Patients undergoing venipuncture

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：

To compare the effects of immersive virtual reality intervention on pain, anxiety stress and length of procedure among pediatric patients, compared to standard care; To evaluate the satisfaction level of healthcare providers on the venipuncture procedure; To evaluate the cost-effectiveness of immersive virtual reality intervention.  

Objectives of Study：

To compare the effects of immersive virtual reality intervention on pain, anxiety stress and length of procedure among pediatric patients, compared to standard care; To evaluate the satisfaction level of healthcare providers on the venipuncture procedure; To evaluate the cost-effectiveness of immersive virtual reality intervention.

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：

(1) identified cognitive and learning problems in their medical record;
(2) sensory impairment to pain (such as spinal bifida);
(3) identified contact precautions; and
(4) previous history of seizures or motion sickness.

Exclusion criteria：

(1) identified cognitive and learning problems in their medical record;
(2) sensory impairment to pain (such as spinal bifida);
(3) identified contact precautions; and
(4) previous history of seizures or motion sickness.

研究实施时间：

Study execute time：

从 From 2019-01-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-01-01 00:00:00 至 To 2020-10-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 100

Group：

Intervention group

Sample size：

干预措施：

Immersive virtual reality

干预措施代码：

Intervention：

Immersive virtual reality

Intervention code：

组别：

Control group

样本量：

 100

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)：

 將軍澳醫院 

单位级别：

 三甲医院 

Institution
hospital：

Tseung Kwan O Hospital

Level of the institution：

hospital

测量指标：

Outcomes：

指标中文名：

Pain

指标类型：

主要指标

Outcome：

Pain

Type：

Primary indicator

测量时间点：

10 min before venipuncture, immediately after venipuncture, 30 min after venipuncture

测量方法：

Faces pain scale-revised

Measure time point of outcome：

10 min before venipuncture, immediately after venipuncture, 30 min after venipuncture

Measure method：

Faces pain scale-revised

指标中文名：

Anxiety

指标类型：

次要指标

Outcome：

Anxiety

Type：

Secondary indicator

测量时间点：

10 min before venipuncture, immediately after venipuncture, 30 min after venipuncture

测量方法：

visual analogue scale (VAS), short form of the Chinese version of the State Anxiety Scale for Children for anxiety

Measure time point of outcome：

10 min before venipuncture, immediately after venipuncture, 30 min after venipuncture

Measure method：

visual analogue scale (VAS), short form of the Chinese version of the State Anxiety Scale for Children for anxiety

指标中文名：

Heart rate

指标类型：

次要指标

Outcome：

Heart rate

Type：

Secondary indicator

测量时间点：

10 min before venipuncture, during venipuncture, immediately after venipuncture, 30 min after venipuncture

测量方法：

automatic heart rate monitoring machine

Measure time point of outcome：

10 min before venipuncture, during venipuncture, immediately after venipuncture, 30 min after venipuncture

Measure method：

automatic heart rate monitoring machine

指标中文名：

Salivary cortisol level

指标类型：

主要指标

Outcome：

Salivary cortisol level

Type：

Primary indicator

测量时间点：

10 min before venipucture and 30 min after venipuncture

测量方法：

Salivary cortisol assay

Measure time point of outcome：

10 min before venipucture and 30 min after venipuncture

Measure method：

Salivary cortisol assay

指标中文名：

Length of venipuncture procedure

指标类型：

次要指标

Outcome：

Length of venipuncture procedure

Type：

Secondary indicator

测量时间点：

during venipuncture

测量方法：

use of a stop watch

Measure time point of outcome：

during venipuncture

Measure method：

use of a stop watch

指标中文名：

Satisfaction level of healthcare providers to the venipuncture procedure

指标类型：

次要指标

Outcome：

Satisfaction level of healthcare providers to the venipuncture procedure

Type：

Secondary indicator

测量时间点：

immediately after venipuncture

测量方法：

staff satisfaction scale

Measure time point of outcome：

immediately after venipuncture

Measure method：

staff satisfaction scale

指标中文名：

Cost-effectiveness

指标类型：

次要指标

Outcome：

Cost-effectiveness

Type：

Secondary indicator

测量时间点：

After the intervention

测量方法：

Cost analysis

Measure time point of outcome：

After the intervention

Measure method：

Cost analysis

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Saliva

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 4 岁 years
最大 Max age 12 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）：

stratified permuted block randomization with a block size of 10. A sequence of grouping identifiers (I=intervention group or C=control group) will be prepared in advance by an independent statistician, using computer-generated random codes for each of the two strata of age group.

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

stratified permuted block randomization with a block size of 10. A sequence of grouping identifiers (I=intervention group or C=control group) will be prepared in advance by an independent statistician, using computer-generated random codes for each of the two strata of age group.

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：

未说明

Blinding：

Not stated

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

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）：

Not stated

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

NA

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：

Not stated

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-10-11 14:05:15
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