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Building Better Mind Maps- Exploratory Study on the healthy adult brain function on mindfulness-based music therapy (RE: Mindful MUSIC) : f NIRIST perspective
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注册号：

Registration number：

 ChiCTR2400081784 

最近更新日期：

Date of Last Refreshed on：

 2024-03-12 08:57:37 

注册时间：

Date of Registration：

 2024-03-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Building Better Mind Maps- Exploratory Study on the healthy adult brain function on mindfulness-based music therapy (RE: Mindful MUSIC) : f NIRIST perspective

Public title：

Building Better Mind Maps- Exploratory Study on the healthy adult brain function on mindfulness-based music therapy (RE: Mindful MUSIC) : f NIRIST perspective

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Building Better Mind Maps- Exploratory Study on the healthy adult brain function on mindfulness-based music therapy (RE: Mindful MUSIC) : f NIRIST perspective

Scientific title：

Building Better Mind Maps- Exploratory Study on the healthy adult brain function on mindfulness-based music therapy (RE: Mindful MUSIC) : f NIRIST perspective

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：

Mr. Armstrong Chiu Tat San 

研究负责人：

Mr. Armstrong Chiu Tat San 

Applicant：

Mr. Armstrong Chiu Tat San 

Study leader：

Mr. Armstrong Chiu Tat San 

申请注册联系人电话：

Applicant telephone：

 +86 136 4234 8062

研究负责人电话：

Study leader's
telephone：

+86 136 4234 8062

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：

 armstrong.chiu@hksb.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 armstrong.chiu@hksb.org.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 The Hong Kong Society for the Blind

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 armstrong.chiu@hksb.org.hk

申请注册联系人通讯地址：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

研究负责人通讯地址：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

Applicant address：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

Study leader's address：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

申请注册联系人邮政编码：

Applicant postcode：

 00000

研究负责人邮政编码：

Study leader's postcode：

 00000

申请人所在单位：

The Hong Kong Society for the Blind

Applicant's institution：

The Hong Kong Society for the Blind

研究负责人所在单位：

The Hong Kong Society for the Blind

Affiliation of the Leader：

The Hong Kong Society for the Blind

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：

 KHAB-20220323-mindfulmusic

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 Ethnical Committee of Kowloon Home for the Aged Blind

Name of the ethic committee：

Research Ethnical Committee of Kowloon Home for the Aged Blind

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-03-23 00:00:00

伦理委员会联系人：

Dr. Wilson Lam Wai Shun

Contact Name of the ethic committee：

Dr. Wilson Lam Wai Shun

伦理委员会联系地址：

W706, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

Contact Address of the ethic committee：

W706, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3723 8381

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 wilson.lam@hksb.org.hk

研究实施负责（组长）单位：

Kowloon Home for the Aged Blind

Primary sponsor：

Kowloon Home for the Aged Blind

研究实施负责（组长）单位地址：

Address: W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

Primary sponsor's address：

Address: W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

HKSAR

市(区县)：

Hong Kong

Country：

China

Province：

HKSAR

City：

Hong Kong

单位(医院)：

Kowloon Home for the Aged Blind

具体地址：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

Institution
hospital：

Kowloon Home for the Aged Blind

Address：

W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon

经费或物资来源：

self financing

Source(s) of funding：

self financing

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：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The project aimed at to utilize the possible effects of mindfulness-based music activity (MindfulMUSIC) exercise, a low-risk and convenient mental wellness program exercise combining music listening and mindfulness, to improve prefrontal oxygenation (PO), which hopefully improves cognitive functions and mental wellness.  

Objectives of Study：

The project aimed at to utilize the possible effects of mindfulness-based music activity (MindfulMUSIC) exercise, a low-risk and convenient mental wellness program exercise combining music listening and mindfulness, to improve prefrontal oxygenation (PO), which hopefully improves cognitive functions and mental wellness.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

The participants with the following criteria were excluded from the study: 1) having any clinical evidence of unstable diseases, (e.g., drug abuse that would alter cerebral blood flow, cardiovascular disease, pulmonary diseases, metabolic diseases, uncontrolled hypertension, cognitive deficit) or not compatible with performing intervention safely and appropriately. 2) Currently participating in a rehabilitation program or taking pharmacological treatment that aims to alleviate the consequences of mental wellness

Exclusion criteria：

The participants with the following criteria were excluded from the study: 1) having any clinical evidence of unstable diseases, (e.g., drug abuse that would alter cerebral blood flow, cardiovascular disease, pulmonary diseases, metabolic diseases, uncontrolled hypertension, cognitive deficit) or not compatible with performing intervention safely and appropriately. 2) Currently participating in a rehabilitation program or taking pharmacological treatment that aims to alleviate the consequences of mental wellness

研究实施时间：

Study execute time：

从 From 2024-03-15 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-15 00:00:00 至 To 2024-08-22 00:00:00

干预措施：

Interventions：

组别：

Study Group

样本量：

 36

Group：

Study Group

Sample size：

干预措施：

All the health adult would like to attend the 45 minutes mindfulness-based music therapy. The subject will wear the light in weight ( fNirsit) wearable brain device in the course of the therapy session.

干预措施代码：

Intervention：

All the health adult would like to attend the 45 minutes mindfulness-based music therapy. The subject will wear the light in weight ( fNirsit) wearable brain device in the course of the therapy session.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 HKSAR 

市(区县)：

  

Country：

China

Province：

HKSAR

City：

单位(医院)：

 Kowloon Home for the Aged Blind 

单位级别：

 N/A 

Institution
hospital：

Kowloon Home for the Aged Blind

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

pre frontal cortex oxgen consumption HBO or reduction HBR

指标类型：

主要指标

Outcome：

pre frontal cortex oxgen consumption HBO or reduction HBR

Type：

Primary indicator

测量时间点：

测量方法：

unctional near-infrared spectroscopy (fNIRSIT) to measure the relative changes in prefrontal oxygenation

Measure time point of outcome：

Measure method：

unctional near-infrared spectroscopy (fNIRSIT) to measure the relative changes in prefrontal oxygenation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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 18 岁 years
最大 Max age 78 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）：

None

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

None

Blinding：

None

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）：

N/A

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

N/A

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：

N/A

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

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-12 08:57:03
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