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【ChiCTR2500113448】The effects of art therapy-based intervention on anxiety children with haematological cancers: a randomised controlled trial

基本信息
登记号

ChiCTR2500113448

试验状态

正在进行

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2025-11-28

临床申请受理号

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靶点

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适应症

haemetoligical cancer

试验通俗题目

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

试验专业题目

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

申办单位信息
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申请人名称
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联系人邮箱
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联系人邮编

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临床试验信息
试验目的

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

试验分类
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试验类型

随机平行对照

试验分期

其它

随机化

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.

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.

试验项目经费来源

试验范围

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目标入组人数

90

实际入组人数

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第一例入组时间

2025-04-25

试验终止时间

2026-08-31

是否属于一致性

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入选标准

(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;

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.;

研究者信息
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试验机构

The Chinese University of Hong Kong

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研究负责人邮编

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