喜好音樂治療對台灣早期青少年同儕依附.憂鬱及唾液皮質醇成效

注册号:

Registration number:

ChiCTR1800016803 

最近更新日期:

Date of Last Refreshed on:

2018-06-25 22:46:43 

注册时间:

Date of Registration:

2018-06-25 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

喜好音樂治療對台灣早期青少年同儕依附.憂鬱及唾液皮質醇成效

Public title:

Effects of Preferred Music Therapy on Peer Attachment, Depression, and Salivary Cortisol Among Early Adolescents in Taiwan

注册题目简写:

音樂治療對青少年同儕依附的成效

English Acronym:

Effectiveness of Music Therapy on Peer Attachment

研究课题的正式科学名称:

喜好音樂治療對台灣早期青少年同儕依附.憂鬱及唾液皮質醇成效

Scientific title:

Effects of Preferred Music Therapy on Peer Attachment, Depression, and Salivary Cortisol Among Early Adolescents in Taiwan

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:

陳貞蓉 

研究负责人:

陳貞蓉 

Applicant:

Chen- Jung Chen 

Study leader:

Chen- Jung Chen 

申请注册联系人电话:

Applicant telephone:

+886 919818364

研究负责人电话:

Study leader's
telephone:

+886 919818364

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:

jan6110@mmc.edu.tw

研究负责人电子邮件:

Study leader's E-mail:

jan6110@yahoo.com.tw

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:

中國臺灣新北市三芝區中正路三段46號

研究负责人通讯地址:

中國臺灣新北市三芝區中正路三段46號

Applicant address:

46 Section 3, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan, China

Study leader's address:

46 Section 3, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan, China

申请注册联系人邮政编码:

Applicant postcode:

252

研究负责人邮政编码:

Study leader's postcode:

252

申请人所在单位:

馬偕醫學院

Applicant's institution:

Mackay Medical College

研究负责人所在单位:

Affiliation of the Leader:

Mackay Medical College

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

14MMHIS177

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:

馬偕紀念醫院人體試驗委員會

Name of the ethic committee:

Mackay Memorial Hospital Institutional Review Board Approval of Clinical Trial

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 00:00:00

伦理委员会联系人:

何重信

Contact Name of the ethic committee:

HE, CHONG-XIN

伦理委员会联系地址:

中國臺灣台北市中山區中山北路二段92號

Contact Address of the ethic committee:

92 Section 2, Zhongshan Road North, Zhongshan District, Taipei, Taiwan, China

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:

研究实施负责(组长)单位:

馬偕醫學院

Primary sponsor:

Mackay Medical College

研究实施负责(组长)单位地址:

中國臺灣新北市三芝區中正路三段46號

Primary sponsor's address:

46 Section 3, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

臺灣

市(区县):

臺北市

Country:

China

Province:

Taiwan

City:

Taipei

单位(医院):

馬偕紀念醫院

具体地址:

台北市中山區中山北路二段92號

Institution
hospital:

Mackay Memorial Hospital

Address:

92 Section 2, Zhongshan Road North, Zhongshan District, Taipei, Taiwan

经费或物资来源:

科技部

Source(s) of funding:

Ministry of Science and Technology

研究疾病:

與其他心理社會情況有關的問題  

Target disease:

Persons with potential health hazards related to socioeconomic and psychosocial circumstances

研究疾病代码:

Z65

Target disease code:

Z65

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

探討喜好音樂治療對台灣早期青少年同儕依附.憂鬱及唾液皮質醇成效  

Objectives of Study:

To explore the effects of Preferred Music Therapy on peer attachment, depression, and salivary cortisol among early adolescents.

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:

由各項訊息中得知患有失聰或診斷有認知障礙者。

Exclusion criteria:

being adolescents with hearing loss or cognitive disorder(s) reported in the questionnaire

研究实施时间:

Study execute time:

From 2014-11-01 00:00:00 To 2016-10-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2016-07-01 00:00:00 To 2016-10-30 00:00:00

干预措施:

Interventions:

组别:

音樂治療組

样本量:

32

Group:

music group

Sample size:

干预措施:

喜好音樂治療

干预措施代码:

Intervention:

Preferred Music Therapy

Intervention code:

组别:

對照組

样本量:

33

Group:

Control group

Sample size:

干预措施:

維持以往生活作息

干预措施代码:

Intervention:

Keep own original regular life style

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國

省(直辖市):

臺灣 

市(区县):

新北市 

Country:

China

Province:

Taiwan

City:

New Taipei

单位(医院):

國中學校 

单位级别:

新北市立中學 

Institution
hospital:

Junior High School

Level of the institution:

New Taipei City Junior High School

测量指标:

Outcomes:

指标中文名:

同儕依附量表

指标类型:

主要指标

Outcome:

The Inventory of Peer Attachment

Type:

Primary indicator

测量时间点:

前-後測

测量方法:

問卷

Measure time point of outcome:

pre- and post intervention

Measure method:

questionnaires

指标中文名:

貝克憂鬱量表

指标类型:

次要指标

Outcome:

The Beck Depression Inventory-II

Type:

Secondary indicator

测量时间点:

前-後測

测量方法:

問卷

Measure time point of outcome:

pre- and post intervention

Measure method:

questionnaires

指标中文名:

皮質醇濃度

指标类型:

次要指标

Outcome:

cortisol concentrations

Type:

Secondary 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:

唾液

组织:

Sample Name:

Salivary

Tissue:

人体标本去向

使用后销毁  

说明

收集後立即檢測後即銷毀

Fate of sample:

Destruction after use  

Note:

Destroyed immediately after use

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 13 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):

概率隨機抽樣進行。應用線上隨機分析軟體以隨機分派方式,將參與者分派至音樂組或對照組。

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

Probability random sampling was performed. Online random analysis software was utilized to randomly assign the participants to the music group or the control group.

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:

Blinding:

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):

共享原始数据 -protocol

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

http://portal.mmc.edu.tw/VC2/teacher/CosFrame.aspx?y=106&s=2&id=NU335&c=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:

数据采集和管理

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

http://portal.mmc.edu.tw/VC2/teacher/CosFrame.aspx?y=106&s=2&id=NU335&c=A

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-06-25 22:46:43