ChiCTR2500112248 版本V1.0 版本创建时间2025/11/11 19:01:12 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：

 ChiCTR2500112248 

最近更新日期：

Date of Last Refreshed on：

 2025-11-11 19:01:07 

注册时间：

Date of Registration：

 2025-11-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

The Effect of Mind-body Intervention on Body Awareness and Emotion Among People with Stagnation Syndrome: A Randomized Controlled Trail

Public title：

The Effect of Mind-body Intervention on Body Awareness and Emotion Among People with Stagnation Syndrome: A Randomized Controlled Trail

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Effect of Mind-body Intervention on Body Awareness and Emotion Among People with Stagnation Syndrome: A Randomized Controlled Trail

Scientific title：

The Effect of Mind-body Intervention on Body Awareness and Emotion Among People with Stagnation Syndrome: A Randomized Controlled Trail

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：

Li Xindi  

研究负责人：

Li Xindi  

Applicant：

Li Xindi  

Study leader：

Li Xindi  

申请注册联系人电话：

Applicant telephone：

 +852 5340 8488

研究负责人电话：

Study leader's
telephone：

+852 5340 8488

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：

 cindylxd@connect.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 cindylxd@connect.hku.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：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

研究负责人通讯地址：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

Applicant address：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

Study leader's address：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

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：

Department of Social Work and Social Administration, The University of Hong Kong

Applicant's institution：

Department of Social Work and Social Administration, The University of Hong Kong

研究负责人所在单位：

Department of Social Work and Social Administration, The University of Hong Kong

Affiliation of the Leader：

Department of Social Work and Social Administration, The 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：

 EA250129

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：

Human Research Ethic Committee of the University of Hong Kong

Name of the ethic committee：

Human Research Ethic Committee of the University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-31 00:00:00

伦理委员会联系人：

Human Research Ethics Committee

Contact Name of the ethic committee：

Human Research Ethics Committee

伦理委员会联系地址：

Research Services of the Registry, 9/F Knowles Building, the University of Hong Kong.

Contact Address of the ethic committee：

Research Services of the Registry, 9/F Knowles Building, the University of Hong Kong.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3917 5267

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：

Department of Social Work and Social Administration, The University of Hong Kong

Primary sponsor：

Department of Social Work and Social Administration, The University of Hong Kong

研究实施负责（组长）单位地址：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

Primary sponsor's address：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Department of Social Work and Social Administration, The University of Hong Kong

具体地址：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

Institution
hospital：

Department of Social Work and Social Administration, The University of Hong Kong

Address：

RM534, The Jockey Club Tower, The Centennial Campus, HKU, Pokfulam, HK

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Stagnation Syndrome  

Target disease：

Stagnation Syndrome

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：

This study aims to achieve three main objectives: 1.Assess the independent effectiveness of acupoint massage and meditation in affecting body awareness and alleviating symptoms in individuals with stagnation syndrome. 2.Explore the role of body awareness in the therapeutic processes of both acupoint massage and meditation. 3.Explore the relationships between distress symptoms, body awareness and emotional variables and their effect on the mind and body.  

Objectives of Study：

This study aims to achieve three main objectives: 1.Assess the independent effectiveness of acupoint massage and meditation in affecting body awareness and alleviating symptoms in individuals with stagnation syndrome. 2.Explore the role of body awareness in the therapeutic processes of both acupoint massage and meditation. 3.Explore the relationships between distress symptoms, body awareness and emotional variables and their effect on the mind and body.

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 between 18 and 65; 2.Sufficient knowledge of the Chinese language; 3. Stagnation syndrome scale total score higher than 50 points at baseline; 4. Willing to give consent by signing a written informed consent form;

Inclusion criteria

1. Aged between 18 and 65; 2.Sufficient knowledge of the Chinese language; 3. Stagnation syndrome scale total score higher than 50 points at baseline; 4. Willing to give consent by signing a written informed consent form;

排除标准：

1. Have cardiovascular disease or other chronic disease 2. Have had previous psychoactive drug treatment; 3. Have current attendance of heart medication or psychotropic pharmacotherapeutics, psychotherapy, heartbeat perception training or mindfulness-based intervention.

Exclusion criteria：

1. Have cardiovascular disease or other chronic disease 2. Have had previous psychoactive drug treatment; 3. Have current attendance of heart medication or psychotropic pharmacotherapeutics, psychotherapy, heartbeat perception training or mindfulness-based intervention.

研究实施时间：

Study execute time：

从 From 2025-02-20 00:00:00至 To 2026-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-06 00:00:00 至 To 2026-09-01 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 30

Group：

Control group

Sample size：

干预措施：

Participants will be asked to stay in the lab and take a relaxation for the first session; during the six-week intervention period, there were no intervention will be provided. After 1-month follow-up, the instruction of acupressure and mindfulness practice will be provided for makeup.

干预措施代码：

Intervention：

Participants will be asked to stay in the lab and take a relaxation for the first session; during the six-week intervention period, there were no intervention will be provided. After 1-month follow-up, the instruction of acupressure and mindfulness practice will be provided for makeup.

Intervention code：

组别：

Acupressure group

样本量：

 30

Group：

Acupressure group

Sample size：

干预措施：

The first session will be conducted in the laboratory with the lead of the researcher, and the following sessions will be conducted at home for the following 4 weeks. An instructive video will be provided for the participants, and there will be a record for participants to complete after each session. Each session will last for 5 minutes, 3 times/ day. After 1-month follow-up, the instruction of mindfulness practice will be provided for reference.

干预措施代码：

Intervention：

The first session will be conducted in the laboratory with the lead of the researcher, and the following sessions will be conducted at home for the following 4 weeks. An instructive video will be provided for the participants, and there will be a record for participants to complete after each session. Each session will last for 5 minutes, 3 times/ day. After 1-month follow-up, the instruction of mindfulness practice will be provided for reference.

Intervention code：

组别：

Mindfulness Group

样本量：

 30

Group：

Mindfulness Group

Sample size：

干预措施：

Participants will be asked to practice in the laboratory by the lead of the researcher, and the following session will be conducted at home for the following 4 weeks. An instructive video will be provided for the participants, and there will be a record for participants to complete after each session. Each practice will last for 5 minutes, 3 times/day. After a 1-month follow-up, the instruction of acupressure will be provided for reference.

干预措施代码：

Intervention：

Participants will be asked to practice in the laboratory by the lead of the researcher, and the following session will be conducted at home for the following 4 weeks. An instructive video will be provided for the participants, and there will be a record for participants to complete after each session. Each practice will last for 5 minutes, 3 times/day. After a 1-month follow-up, the instruction of acupressure will be provided for reference.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong  

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Department of Social Work and Social Administration, The University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Department of Social Work and Social Administration, The University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Interceptive Accuracy

指标类型：

主要指标

Outcome：

Interceptive Accuracy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interoceptive Sensibility

指标类型：

主要指标

Outcome：

Interoceptive Sensibility

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interoceptive Coherence

指标类型：

主要指标

Outcome：

Interoceptive Coherence

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interoceptive Evaluation

指标类型：

主要指标

Outcome：

Interoceptive Evaluation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Porges Body Perception Questionnaire (BPQ)

指标类型：

主要指标

Outcome：

Porges Body Perception Questionnaire (BPQ)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Multidimensional Assessment of Interoceptive Awareness Version 2- Chinese (MAIA-2)

指标类型：

主要指标

Outcome：

Multidimensional Assessment of Interoceptive Awareness Version 2- Chinese (MAIA-2)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Stagnation Scale

指标类型：

主要指标

Outcome：

Stagnation Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Brain activity by Electroencephalogram (EEG)

指标类型：

主要指标

Outcome：

Brain activity by Electroencephalogram (EEG)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cardiac activity by Electrocardiogram (ECG)

指标类型：

主要指标

Outcome：

Cardiac activity by Electrocardiogram (ECG)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Hospital Anxiety and Depression Scale (HADS) (Chinese Version)

指标类型：

次要指标

Outcome：

Hospital Anxiety and Depression Scale (HADS) (Chinese Version)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Emotion Regulation Skills Questionnaire

指标类型：

次要指标

Outcome：

Emotion Regulation Skills Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Constitution in Chinese Medicine Questionare (CCMQ)-Qi Depression subscale

指标类型：

次要指标

Outcome：

Constitution in Chinese Medicine Questionare (CCMQ)-Qi Depression subscale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interview

指标类型：

附加指标

Outcome：

Interview

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Intervention Quality

指标类型：

附加指标

Outcome：

Intervention Quality

Type：

Additional 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

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 65 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）：

Using computer-generated random numbers and allocated eligible participants to one of the three study groups in a 1:1:1 ratio

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

Using computer-generated random numbers and allocated eligible participants to one of the three study groups in a 1:1:1 ratio

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 researcher responsible for data analysis will be blinded, but participants and experimenters responsible for collecting data will not be blinded.

Blinding：

The researcher responsible for data analysis will be blinded, but participants and experimenters responsible for collecting data will not be blinded.

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）：

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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

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

EDC

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：

  2025-11-11 19:01:07