ChiCTR2200064166 版本V1.0 版本创建时间2022/09/28 23:22:12 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：

 ChiCTR2200064166 

最近更新日期：

Date of Last Refreshed on：

 2022-09-28 23:22:04 

注册时间：

Date of Registration：

 2022-09-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The efficacy of a group-based music imagery programme—A randomized controlled trial

Public title：

The efficacy of a group-based music imagery programme—A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Group-based music imagery programme

Scientific title：

Group-based music imagery programme

研究课题代号(代码)：

Study subject ID：

 2019-00-51CRG041906

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：

NA

申请注册联系人：

Winnie Cheng 

研究负责人：

Winnie Cheng 

Applicant：

Winnie Cheng 

Study leader：

Winnie Cheng 

申请注册联系人电话：

Applicant telephone：

 852 91794786

研究负责人电话：

Study leader's
telephone：

852 91794786

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：

 winniecheng@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 winniecheng@twc.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：

31, Wylie Road, Homantin, Hong Kong

研究负责人通讯地址：

31, Wylie Road, Homantin, Hong Kong

Applicant address：

31, Wylie Road, Homantin, Hong Kong

Study leader's address：

31, Wylie Road, Homantin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 Hong Kong

研究负责人邮政编码：

Study leader's postcode：

 Hong Kong

申请人所在单位：

Tung Wah College

Applicant's institution：

Tung Wah College

研究负责人所在单位：

Affiliation of the Leader：

Tung Wah College

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：

 REC2020076

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 Ethics Committee, Tung Wah College

Name of the ethic committee：

Research Ethics Committee, Tung Wah College

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-09-23 00:00:00

伦理委员会联系人：

Secretary, Research Ethics Committee (REC), TWC

Contact Name of the ethic committee：

Secretary, Research Ethics Committee (REC), TWC

伦理委员会联系地址：

Research Ethics Committee (REC), 31, Wylie Road, Homantin, Hong Kong

Contact Address of the ethic committee：

Research Ethics Committee (REC), 31, Wylie Road, Homantin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ro@twc.edu.hk

研究实施负责（组长）单位：

Tung Wah College

Primary sponsor：

College Research Grant, Tung Wah College

研究实施负责（组长）单位地址：

31, Wylie Road, Homantin, Hong Kong

Primary sponsor's address：

31, Wylie Road, Homantin, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

NA

Province：

NA

City：

单位(医院)：

具体地址：

Institution
hospital：

NA

Address：

NA

经费或物资来源：

College Research Grant, Tung Wah College

Source(s) of funding：

College Research Grant, Tung Wah College

研究疾病：

Stress and coping  

Target disease：

Stress and coping

研究疾病代码：

NA

Target disease code：

NA

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

- To evaluate the effects of the Focused Music Imagery program in reducing the stress-associated symptoms of young adults. - To evaluate the effects of Focused Music Imagery program in enhancing the coping resources of young adults  

Objectives of Study：

- To evaluate the effects of the Focused Music Imagery program in reducing the stress-associated symptoms of young adults. - To evaluate the effects of Focused Music Imagery program in enhancing the coping resources of young adults

药物成份或治疗方案详述：

The proposed study attempts to investigate the efficacy of a group-based guided music imagery program, namely Focused Music Imagery (FMI) using randomized controlled trial design to enhance coping in young adults. FMI is a form of therapeutic process that integrating both music and visual arts to explore the inner consciousness and resources. The process is characterized by visualization of image during the drawing while listening to music. A weekly FMI program for 6 weeks will be delivered to a group of 10 participants by a music therapist with training in FMI and consultation. Each 120-minute session of the FMI is structured with 3 components, namely Prelude, Music Imagery, and Postlude. A selection of non-vocal, non-classical musical pieces, with melody non-evoking but holding in nature, and simple in musical form; will be prepared in advance. Each musical piece lasts about 3 - 7 minutes.  

Description for medicine or protocol of treatment in detail：

The proposed study attempts to investigate the efficacy of a group-based guided music imagery program, namely Focused Music Imagery (FMI) using randomized controlled trial design to enhance coping in young adults. FMI is a form of therapeutic process that integrating both music and visual arts to explore the inner consciousness and resources. The process is characterized by visualization of image during the drawing while listening to music. A weekly FMI program for 6 weeks will be delivered to a group of 10 participants by a music therapist with training in FMI and consultation. Each 120-minute session of the FMI is structured with 3 components, namely Prelude, Music Imagery, and Postlude. A selection of non-vocal, non-classical musical pieces, with melody non-evoking but holding in nature, and simple in musical form; will be prepared in advance. Each musical piece lasts about 3 - 7 minutes.  

纳入标准：

A sample will be drawn from the population of young people (aged from 16 – 25) attending tertiary education institution. Subjects will be recruited from the contact list of the institution via an email message, the potential participants will be invited to pass on the email message to their connections for possible participation in the study.

Inclusion criteria

A sample will be drawn from the population of young people (aged from 16 – 25) attending tertiary education institution. Subjects will be recruited from the contact list of the institution via an email message, the potential participants will be invited to pass on the email message to their connections for possible participation in the study.

排除标准：

Exclusion criteria include the history of diagnosed psychiatric disease, current acute mental problem, or experience with music imagery.

Exclusion criteria：

Exclusion criteria include the history of diagnosed psychiatric disease, current acute mental problem, or experience with music imagery.

研究实施时间：

Study execute time：

从 From 2020-10-01 00:00:00至 To 2023-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-30 00:00:00 至 To 2023-01-31 00:00:00

干预措施：

Interventions：

组别：

样本量：

 95

Group：

experimental

Sample size：

干预措施：

干预措施代码：

Intervention：

Focused Music Imagery weekly for 6 weeks

Intervention code：

组别：

样本量：

 95

Group：

control

Sample size：

干预措施：

干预措施代码：

Intervention：

music listening and drawing weekly for 6 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

  

单位级别：

 高校 

Institution
hospital：

Tung Wah College

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

壓力知覺量表

指标类型：

主要指标

Outcome：

Perceived stress scale (PSS)

Type：

Primary indicator

测量时间点：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

测量方法：

self-administered questionnaire

Measure time point of outcome：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

Measure method：

self-administered questionnaire

指标中文名：

生命凝聚感

指标类型：

次要指标

Outcome：

Sense of Coherence Scale (C‐SOC‐13)

Type：

Secondary indicator

测量时间点：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

测量方法：

self-administered questionnaire

Measure time point of outcome：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

Measure method：

self-administered questionnaire

指标中文名：

壓力心態

指标类型：

次要指标

Outcome：

Stress mindset measure (SMM)

Type：

Secondary indicator

测量时间点：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

测量方法：

self-administered questionnaire

Measure time point of outcome：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

Measure method：

self-administered questionnaire

指标中文名：

自我同情量表

指标类型：

次要指标

Outcome：

Self-compassion scale -SF

Type：

Secondary indicator

测量时间点：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

测量方法：

self-administered questionnaire

Measure time point of outcome：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

Measure method：

self-administered questionnaire

指标中文名：

广泛性焦虑量表

指标类型：

主要指标

Outcome：

Generalized Anxiety Disorder scale (GAD-7)

Type：

Primary indicator

测量时间点：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

测量方法：

self-administered questionnaire

Measure time point of outcome：

collected before the study begins (T0); post intervention at week 7 (T1); and 4 weeks post intervention (T2).

Measure method：

self-administered questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

none

Tissue：

None

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

none

征募研究对象情况：

Recruiting status：

暂停或中断

Suspending

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 25 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）：

Simple randomization by computer-based two-digit random number with Excel 2007 (Microsoft, Redmond, WA, USA) will be used to allocate participants to either intervention group or control group after their consent to participate the proposed study.

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

Simple randomization by computer-based two-digit random number with Excel 2007 (Microsoft, Redmond, WA, USA) will be used to allocate participants to either intervention group or control group after their consent to participate the proposed study.

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：

The subjects will be blinded.

Blinding：

The subjects will be blinded.

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）：

none

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

none

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：

All data will be kept strictly confidential and anonymous. The participants will be assigned code numbers that will not reveal their identity. All identifiable data (consent forms and master lists of codes) will be locked in a separate filing cabinet to which only the research team will have access. The results will be collectively collated and analysed. No identifying individual information will be presented or reported.

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

All data will be kept strictly confidential and anonymous. The participants will be assigned code numbers that will not reveal their identity. All identifiable data (consent forms and master lists of codes) will be locked in a separate filing cabinet to which only the research team will have access. The results will be collectively collated and analysed. No identifying individual information will be presented or reported.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-09-28 23:22:04