【ChiCTR2000032495】Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

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基本信息

登记号

ChiCTR2000032495

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-04-30

临床申请受理号

靶点

适应症

Attention deficit hyperactivity disorder (ADHD)

试验通俗题目

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

试验专业题目

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

申办单位信息

申请人联系人

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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

999077

联系人通讯地址

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临床试验信息

试验目的

To preliminarily assess the effects and feasibility of parent-delivered pediatric tuina for ADHD symptoms in preschool children for a further fully powered RCT.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Participants will be randomly assigned to either intervention group or active control group in a 1:1 ratio by a computer-generated randomization schedule using permuted blocks of random sizes.

盲法

Not stated

试验项目经费来源

Associated money

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-05-31

试验终止时间

2021-01-31

是否属于一致性

入选标准

Inclusion criteria for the children are: (1) children between 3-7 years old by the time of the start of the assessment; Children with ADHD symptoms of hyperactivity, anxiety, or inattention will be recruited in this study. Inclusion criteria for parents are: (1) able to communicate using Mandarin; (2) willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD; (3) available to take their child to hospital for treatment and conduct manipulations at home according to the study process; (4) agree to give informed consent.；

排除标准

Exclusion criteria for children are: (1) currently receiving other massage therapy; (2) having other developmental disability such as autism spectrum disorders or intellectual disability; (3) having acute infection diseases (such as scarlet fever, chickenpox), hemorrhagic diseases (like bleeding, local places of various kinds of malignant tumor), or dermatological problems (e.g. scald, severe skin lesion, or skin infections); (4) having any severe illness or medical condition that the investigator deems not appropriate to receive TCM massage (e.g. bone fractures and paraplegia). Exclusion criteria for parents are: (1) having any severe psychiatric disorder, such as major depressive disorder; (2) having difficulties to conduct massage therapy due to physical problems; (3) having a score of Montreal Cognitive Assessment (MoCA) less than 22, indicating cognitive impairment (Appendix 1: Montreal Cognitive Assessment (MoCA) – Chinese Version)；

研究者信息

研究负责人姓名

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试验机构

香港理工大學

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

999077

联系人通讯地址