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Efficacy of using a cartoon booklet to reduce perioperative anxiety in paediatric patients and their parents
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注册号：

Registration number：

 ChiCTR1900028512 

最近更新日期：

Date of Last Refreshed on：

 2019-12-24 23:35:28 

注册时间：

Date of Registration：

 2019-12-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Efficacy of using a cartoon booklet to reduce perioperative anxiety in paediatric patients and their parents

Public title：

Efficacy of using a cartoon booklet to reduce perioperative anxiety in paediatric patients and their parents

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Efficacy of using a cartoon booklet to reduce perioperative anxiety in paediatric patients and their parents

Scientific title：

Efficacy of using a cartoon booklet to reduce perioperative anxiety in paediatric patients and their parents

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：

Grace Sze Man Tang 

研究负责人：

Grace Sze Man Tang 

Applicant：

Grace Sze Man Tang 

Study leader：

Grace Sze Man Tang 

申请注册联系人电话：

Applicant telephone：

 +852 55699485

研究负责人电话：

Study leader's
telephone：

+852 55699485

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：

 tsm102@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 tsm102@ha.org.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威爾士親王醫院麻醉與重症監護部

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院麻醉與重症監護部

Applicant address：

4/F New block, Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong, China

Study leader's address：

4/F New block, Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, 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

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

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：

 2018.226-T

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：

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：

 1990-01-01 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醫院呂志和臨床科學大樓8/F

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

Primary sponsor：

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威爾士親王醫院麻醉與重症監護部

Primary sponsor's address：

4/F New block, Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong, China

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：

anxiety  

Target disease：

anxiety

研究疾病代码：

Target disease code：

研究类型：

预防性研究

Study type：

Prevention

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：

Child anxiety may vary according to ethnicity and language5. We have developed a cartoon booklet which tells the story of a little bear going through an operation. The scene is particularly designed by local graphic designers to portray the operation theatre setting at our hospital. To our knowledge it is the first printed cartoon material for this purpose in the region catered for Chinese paediatric patients. We postulate that by implementing the distribution of the cartoon booklet, we would reduce perioperative anxiety in paediatric patients  

Objectives of Study：

Child anxiety may vary according to ethnicity and language5. We have developed a cartoon booklet which tells the story of a little bear going through an operation. The scene is particularly designed by local graphic designers to portray the operation theatre setting at our hospital. To our knowledge it is the first printed cartoon material for this purpose in the region catered for Chinese paediatric patients. We postulate that by implementing the distribution of the cartoon booklet, we would reduce perioperative anxiety in paediatric patients

药物成份或治疗方案详述：

This is a single-blinded, randomized- controlled trial. Patients are randomized prospectively to either receive the cartoon booklet or to standard clinical practice (control group). Patients will be randomized using computer programs by a third party (other than the study investigators). Fifty patients (25 in each group) will be recruited. In the control group, the standard general anaesthesia information sheet will be given to the parents. In the study group, the cartoon booklet will be given together with the general anaesthesia information sheet. The anaesthesiologists and research staff who are responsible for assessment in operating theatre area are blinded to the group patient is assigned to. 

Description for medicine or protocol of treatment in detail：

This is a single-blinded, randomized- controlled trial. Patients are randomized prospectively to either receive the cartoon booklet or to standard clinical practice (control group). Patients will be randomized using computer programs by a third party (other than the study investigators). Fifty patients (25 in each group) will be recruited. In the control group, the standard general anaesthesia information sheet will be given to the parents. In the study group, the cartoon booklet will be given together with the general anaesthesia information sheet. The anaesthesiologists and research staff who are responsible for assessment in operating theatre area are blinded to the group patient is assigned to. 

纳入标准：

Inclusion criteria

排除标准：

1. Patient with developmental delay or central nervous system dysfunction;
2. Patients who cannot read or write or understand Chinese;
3. Patients who were given sedations preoperatively.

Exclusion criteria：

1. Patient with developmental delay or central nervous system dysfunction;
2. Patients who cannot read or write or understand Chinese;
3. Patients who were given sedations preoperatively.

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：

2 groups

样本量：

 50

Group：

2 Groups

Sample size：

干预措施：

cartoon booklet

干预措施代码：

Intervention：

cartoon booklet

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：

  

Institution
hospital：

Prince of wales hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

anxiety score

指标类型：

主要指标

Outcome：

anxiety score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

anxiety

指标类型：

主要指标

Outcome：

anxiety

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

anxiety

指标类型：

主要指标

Outcome：

anxiety

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Nil

组织：

Sample Name：

nil

Tissue：

nil

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

nil

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 3 岁 years
最大 Max age 10 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）：

Patients will be randomized using computer programs by a third party (other than the study investigators)

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

Patients will be randomized using computer programs by a third party (other than the study investigators)

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：

Open label

Blinding：

Open label

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）：

ResMan, http://www.medresman.org

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

ResMan, http://www.medresman.org

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：

NA

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：

  2019-12-24 23:35:28
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