ChiCTR2600118805 版本V1.0 版本创建时间2026/02/11 10:17:23 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：

 ChiCTR2600118805 

最近更新日期：

Date of Last Refreshed on：

 2026-02-11 10:17:15 

注册时间：

Date of Registration：

 2026-02-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The Potential Psychological Benefits of a Mindfulness-Based, Sound-Focused Singing Bowl Intervention: A Pilot Randomized Controlled Trial

Public title：

The Potential Psychological Benefits of a Mindfulness-Based, Sound-Focused Singing Bowl Intervention: A Pilot Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Potential Psychological Benefits of a Mindfulness-Based, Sound-Focused Singing Bowl Intervention: A Pilot Randomized Controlled Trial

Scientific title：

The Potential Psychological Benefits of a Mindfulness-Based, Sound-Focused Singing Bowl Intervention: A Pilot Randomized 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：

Andy Fung 

研究负责人：

Mo Lai Ching, Jessica 

Applicant：

Andy Fung 

Study leader：

Mo Lai Ching, Jessica 

申请注册联系人电话：

Applicant telephone：

 +852 3400 3917

研究负责人电话：

Study leader's
telephone：

+852 3963 5664

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：

 andy.hw.fung@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 jessicamo@hsu.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：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

研究负责人通讯地址：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., Hong Kong

Applicant address：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Study leader's address：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., 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：

Hong Kong Polytechnic University

Applicant's institution：

Hong Kong Polytechnic University

研究负责人所在单位：

Hang Seng University of Hong Kong

Affiliation of the Leader：

Hang Seng 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：

 02022026113650-0001

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：

Research Policy and Scholarly Activities Committee of the Hang Seng University of Hong Kong

Name of the ethic committee：

Research Policy and Scholarly Activities Committee of the Hang Seng University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-15 00:00:00

伦理委员会联系人：

Research Policy and Scholarly Activities Committee of the Hang Seng University of Hong Kong

Contact Name of the ethic committee：

Professor Joshua Mok Ka-ho

伦理委员会联系地址：

Research Policy and Scholarly Activities Committee of the Hang Seng University of Hong Kong

Contact Address of the ethic committee：

Research Policy and Scholarly Activities Committee of the Hang Seng University of Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3963 5000

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：

Hang Seng University of Hong Kong

Primary sponsor：

Hang Seng University of Hong Kong

研究实施负责（组长）单位地址：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., Hong Kong

Primary sponsor's address：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., Hong Kong

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)：

Hang Seng University of Hong Kong

具体地址：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., Hong Kong

Institution
hospital：

Hang Seng University of Hong Kong

Address：

Hang Shin Link, Siu Lek Yuen, Shatin, N.T., Hong Kong

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

None  

Target disease：

None

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 will test the following hypotheses: 1) The intervention will be feasible: Enough participants can be recruited on time. 2) The intervention will be acceptable: The retention rate will be acceptable (over 70%). 3) The intervention will be safe: No or only minimal adverse events will be reported. 4) The intervention will be effective: Compared to the control group, the intervention group will have significantly greater improvements on primary (psychological symptoms and sleep) and secondary (self-esteem, experiential avoidance, self-compassion) outcome measures.  

Objectives of Study：

This study will test the following hypotheses: 1) The intervention will be feasible: Enough participants can be recruited on time. 2) The intervention will be acceptable: The retention rate will be acceptable (over 70%). 3) The intervention will be safe: No or only minimal adverse events will be reported. 4) The intervention will be effective: Compared to the control group, the intervention group will have significantly greater improvements on primary (psychological symptoms and sleep) and secondary (self-esteem, experiential avoidance, self-compassion) outcome measures.

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 18 or above 2.A Hong Kong resident 3.Can communicate in Chinese-Cantonese 4.Agree to provide informed consent and participate in this trial 5.Want to improve their emotional well-being.

Inclusion criteria

1.Aged 18 or above 2.A Hong Kong resident 3.Can communicate in Chinese-Cantonese 4.Agree to provide informed consent and participate in this trial 5.Want to improve their emotional well-being.

排除标准：

1.Any officially diagnosed psychiatric disorders or any health conditions that may affect their participation (e.g., hearing impairments, dementia); or, 2.Self-report having suicidal thoughts or attempts in the past 2 months; 3.Prior regular singing bowl experience.

Exclusion criteria：

1.Any officially diagnosed psychiatric disorders or any health conditions that may affect their participation (e.g., hearing impairments, dementia); or, 2.Self-report having suicidal thoughts or attempts in the past 2 months; 3.Prior regular singing bowl experience.

研究实施时间：

Study execute time：

从 From 2026-02-28 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-28 00:00:00 至 To 2026-09-30 00:00:00

干预措施：

Interventions：

组别：

intervention group

样本量：

 30

Group：

intervention group

Sample size：

干预措施：

a 6-week mindfulness-based, sound-focused singing bowl group intervention

干预措施代码：

Intervention：

a 6-week mindfulness-based, sound-focused singing bowl group intervention

Intervention code：

组别：

control group

样本量：

 30

Group：

control group

Sample size：

干预措施：

none

干预措施代码：

Intervention：

none

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)：

 Hang Seng University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Hang Seng University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

depression

指标类型：

主要指标

Outcome：

depression

Type：

Primary indicator

测量时间点：

baseline, 2-month follow-up, and 4-month follow-up

测量方法：

Depression Anxiety Stress Scales-21

Measure time point of outcome：

baseline, 2-month follow-up, and 4-month follow-up

Measure method：

Depression Anxiety Stress Scales-21

指标中文名：

insomnia symptoms

指标类型：

主要指标

Outcome：

insomnia symptoms

Type：

Primary indicator

测量时间点：

baseline, 2-month follow-up, and 4-month follow-up

测量方法：

Insomnia Severity Index (ISI)

Measure time point of outcome：

baseline, 2-month follow-up, and 4-month follow-up

Measure method：

Insomnia Severity Index (ISI)

指标中文名：

Self-esteem

指标类型：

次要指标

Outcome：

Self-esteem

Type：

Secondary indicator

测量时间点：

测量方法：

single-item measure of self-esteem (SISE)

Measure time point of outcome：

Measure method：

single-item measure of self-esteem (SISE)

指标中文名：

experiential avoidance

指标类型：

次要指标

Outcome：

experiential avoidance

Type：

Secondary indicator

测量时间点：

测量方法：

Preference to Avoid Self-Experiences (PASE)

Measure time point of outcome：

Measure method：

Preference to Avoid Self-Experiences (PASE)

指标中文名：

Self-compassion

指标类型：

次要指标

Outcome：

Self-compassion

Type：

Secondary indicator

测量时间点：

测量方法：

Self-compassion Scale-Short Form (SCS-SF)

Measure time point of outcome：

Measure method：

Self-compassion Scale-Short Form (SCS-SF)

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：

stress

指标类型：

主要指标

Outcome：

stress

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

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

Participants who meet all inclusion criteria will be randomly assigned to the intervention group or the control group. An independent researcher who is blind to the screening assessment results will perform the randomization using a simple randomization method.

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

Participants who meet all inclusion criteria will be randomly assigned to the intervention group or the control group. An independent researcher who is blind to the screening assessment results will perform the randomization using a simple randomization method.

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：

None - the measures will be completed by self-report data.

Blinding：

None - the measures will be completed by self-report data.

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）：

NA

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

NA

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：

Electronic Data Capture

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

Electronic Data Capture

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：

  2026-02-11 10:17:15