ChiCTR2500113448 版本V1.0 版本创建时间2025/11/28 10:54:02 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500113448 

最近更新日期：

Date of Last Refreshed on：

 2025-11-28 10:53:55 

注册时间：

Date of Registration：

 2025-11-28 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

The effects of art therapy-based intervention on anxiety children with haematological cancers: a randomised controlled trial

Public title：

The effects of art therapy-based intervention on anxiety children with haematological cancers: a randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of art therapy-based intervention on anxiety children with haematological cancers: a randomised controlled trial

Scientific title：

The effects of art therapy-based intervention on anxiety children with haematological cancers: a randomised 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：

Zhou ShiShuang 

研究负责人：

Zhou ShiShuang 

Applicant：

Zhou ShiShuang 

Study leader：

Zhou ShiShuang 

申请注册联系人电话：

Applicant telephone：

 +86 191 1929 6471

研究负责人电话：

Study leader's
telephone：

+86 191 1929 6471

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：

 1155206740@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1155206740@link.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：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

研究负责人通讯地址：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

Applicant address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

Study leader's address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

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：

 2024.690-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：

The Joint CUHK-NTEC CREC

Name of the ethic committee：

The Joint CUHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-18 00:00:00

伦理委员会联系人：

Not stated

Contact Name of the ethic committee：

Not stated

伦理委员会联系地址：

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

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

Primary sponsor's address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

haemetoligical cancer  

Target disease：

haemetoligical 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To determine the effectiveness of the art therapy-based intervention on anxiety, depression, coping and HRQoL  

Objectives of Study：

To determine the effectiveness of the art therapy-based intervention on anxiety, depression, coping and HRQoL

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(1) Aged 7 to 14 years. (2) Clinically diagnosed with any type of haematological cancer. (3) Currently undergoing a chemotherapy course. (4) Able to provide written informed consent by a legal/parent guardian and assent from children (5) Able to speak and understand Chinese. (6) Presence of anxiety symptoms. The 100 mm visual analogue scale (VAS) for anxiety with faces (a single-item instrument) ranging from 0 to 10 will be administered to detect anxiety with a threshold of 3

Inclusion criteria

(1) Aged 7 to 14 years. (2) Clinically diagnosed with any type of haematological cancer. (3) Currently undergoing a chemotherapy course. (4) Able to provide written informed consent by a legal/parent guardian and assent from children (5) Able to speak and understand Chinese. (6) Presence of anxiety symptoms. The 100 mm visual analogue scale (VAS) for anxiety with faces (a single-item instrument) ranging from 0 to 10 will be administered to detect anxiety with a threshold of 3

排除标准：

(1) Presence of developmental, physical, psychological, and/or psychiatric illness or problems as indicated in?the medical records. (2) Participating in other ongoing research studies.

Exclusion criteria：

(1) Presence of developmental, physical, psychological, and/or psychiatric illness or problems as indicated in?the medical records. (2) Participating in other ongoing research studies.

研究实施时间：

Study execute time：

从 From 2025-04-25 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-25 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

Control

样本量：

 90

Group：

Control

Sample size：

干预措施：

The control group participants will receive usual care, which includes routine medical care to monitor disease status, administer chemotherapy, provide disease-related information, and refer to psychological support as needed.

干预措施代码：

Intervention：

The control group participants will receive usual care, which includes routine medical care to monitor disease status, administer chemotherapy, provide disease-related information, and refer to psychological support as needed.

Intervention code：

组别：

Intervention

样本量：

 90

Group：

Intervention

Sample size：

干预措施：

In addition to the usual care received by the control group, the intervention group will receive the standardised art therapy-based intervention. The details as follows: A group format with four weekly sessions lasting 40-60 minutes is designed. Each session will involve some nursing components: knowledge about disease and chemotherapy and the role of health professionals. Week 1: Free painting to explore the cancer journey. Week 2:Tree painting and collaging to explore coping resources. Week 3:Clay modelling and painting focused on wishful thinking. Week 4:Handmaking to reinforce previous learning.

干预措施代码：

Intervention：

In addition to the usual care received by the control group, the intervention group will receive the standardised art therapy-based intervention. The details as follows: A group format with four weekly sessions lasting 40-60 minutes is designed. Each session will involve some nursing components: knowledge about disease and chemotherapy and the role of health professionals. Week 1: Free painting to explore the cancer journey. Week 2:Tree painting and collaging to explore coping resources. Week 3:Clay modelling and painting focused on wishful thinking. Week 4:Handmaking to reinforce previous learning.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 GuiZhou 

市(区县)：

  

Country：

China

Province：

GuiZhou

City：

单位(医院)：

 Guiyang Maternal And Child Health Care Hospital Guiyang Children's Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Guiyang Maternal And Child Health Care Hospital Guiyang Children's Hospital

Level of the institution：

Tertiary

国家：

 China

省(直辖市)：

 Guangdong 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 Guangzhou woman and children's medical centre 

单位级别：

 tertiary 

Institution
hospital：

Guangzhou woman and children's medical centre

Level of the institution：

tertiary

国家：

 China

省(直辖市)：

 HuNan 

市(区县)：

  

Country：

China

Province：

HuNan

City：

单位(医院)：

 HuNan Children's hopital 

单位级别：

 tertiary 

Institution
hospital：

HuNan Children's hopital

Level of the institution：

tertiary

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：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

depression

指标类型：

次要指标

Outcome：

depression

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

coping

指标类型：

次要指标

Outcome：

coping

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

quality of life

指标类型：

主要指标

Outcome：

quality of life

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：

none

组织：

Sample Name：

none

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 7 岁 years
最大 Max age 14 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）：

Eligible participants will be assigned in a 1:1 ratio to the intervention and control groups using computer-generated random numbers through blocked randomisation with a block size of four (Lim & In, 2019). Opaque, sequentially numbered, sealed envelopes will be provided to participants based on their enrolment sequence after completing baseline assessments. A research assistant (RA1), blinded to the study’s aims and objectives, will generate the random numbers, prepare envelopes, and record assignments but will not be involved in further study procedures. The outcome assessor (RA2) will be blinded to the group assignments. Owing to the nature of the intervention design, blinding of group allocation for participants and intervention deliverers is not feasible. The participants will be instructed not to disclose their allocation information to the outcome assessors.

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

Eligible participants will be assigned in a 1:1 ratio to the intervention and control groups using computer-generated random numbers through blocked randomisation with a block size of four (Lim & In, 2019). Opaque, sequentially numbered, sealed envelopes will be provided to participants based on their enrolment sequence after completing baseline assessments. A research assistant (RA1), blinded to the study’s aims and objectives, will generate the random numbers, prepare envelopes, and record assignments but will not be involved in further study procedures. The outcome assessor (RA2) will be blinded to the group assignments. Owing to the nature of the intervention design, blinding of group allocation for participants and intervention deliverers is not feasible. The participants will be instructed not to disclose their allocation information to the outcome assessors.

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：

The outcome assessor (RA2) will be blinded to the group assignments. Owing to the nature of the intervention design, blinding of group allocation for participants and intervention deliverers is not feasible. The participants will be instructed not to disclose their allocation information to the outcome assessors.

Blinding：

The outcome assessor (RA2) will be blinded to the group assignments. Owing to the nature of the intervention design, blinding of group allocation for participants and intervention deliverers is not feasible. The participants will be instructed not to disclose their allocation information to the outcome assessors.

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）：

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

EDC. China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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

EDC. China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

  2025-11-28 10:53:55