今天是:2019-08-22 星期四

心理弹性训练改善耳鸣患者心理困扰的随机对照研究
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注册号:

Registration number:

ChiCTR1900023179 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

心理弹性训练改善耳鸣患者心理困扰的随机对照研究 

Public title:

Resilience training to improve tinnitus distress: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心理弹性训练改善耳鸣患者心理困扰的随机对照研究 

Scientific title:

Resilience training to improve tinnitus distress: a 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:

黎志成 

研究负责人:

黎志成 

Applicant:

Li Zhicheng 

Study leader:

Li Zhicheng 

申请注册联系人电话:

Applicant telephone:

+86 13580424206 

研究负责人电话:

Study leader's telephone:

+86 13580424206 

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:

43812490@QQ.com 

研究负责人电子邮件:

Study leader's E-mail:

43812490@QQ.com 

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:

广东省广州市天河路600号 

研究负责人通讯地址:

广东省广州市天河路600号 

Applicant address:

600 Tianhe Road, Guangzhou, Guangdong, China 

Study leader's address:

600 Tianhe Road, Guangzhou, Guangdong, China 

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:

中山大学附属第三医院耳鼻咽喉-头颈外科 

Applicant's institution:

Department of Otolaryngology head and neck surgery, the Third Affiliated Hospital of Sun Yat-sen University 

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:

中大附三医伦[2019]02-229-01 

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:

中山大学附属第三医院医学伦理委员会 

Name of the ethic committee:

the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

黄桂珍 

Contact Name of the ethic committee:

Huang Guizhen 

伦理委员会联系地址:

广东省广州市天河路600号 

Contact Address of the ethic committee:

600 Tianhe Road, Guangzhou, Guangdong, 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:

中山大学附属第三医院 

Primary sponsor:

the Third Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市天河路600号 

Primary sponsor's address:

600 Tianhe Road, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第三医院

具体地址:

广东省广州市天河路600号

Institution
hospital:

the Third Affiliated Hospital of Sun Yat-sen University

Address:

600 Tianhe Road, Guangzhou

经费或物资来源:

中山大学附属第三医院临床医学研究专项基金 

Source(s) of funding:

the Third Affiliated Hospital of Sun Yat-Sen University, Clinical Research Program 

研究疾病:

耳鸣 

Target disease:

tinnitus 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过随机对照研究探讨心理弹性训练改善耳鸣患者心理困扰的效果。 

Objectives of Study:

To explore the effect of Resilience training on tinnitus distress through a randomized controlled study. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①以耳鸣为第一主诉求诊于我科; ②耳鸣病程>6月; ③THI得分≧38分; ④常居广州或往来医院便利; ⑤自愿参与本研究。 

Inclusion criteria

1. tinnitus as the first complaint; 2. persistent for > 6 months; 3. THI≧38 scores; 4. live in Guangzhou or convenient to and from hospital; 5. Voluntary participation in this study. 

排除标准:

①有严重的神经或精神疾病病史; ②患者无法充分理解量表内容。 

Exclusion criteria:

1. with history of neurological and psychiatric diseases; 2. The patient could not fully understand the content of the scale. 

研究实施时间:

Study execute time:

From2019-06-01To 2022-05-31 

干预措施:

Interventions:

组别:

训练组

样本量:

25

Group:

Training Group

Sample size:

干预措施:

心理弹性训练

干预措施代码:

Intervention:

Resilience training

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

耳鸣残疾量表评分

指标类型:

主要指标 

Outcome:

Score of tinnitus handicap inventory

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理弹性评分

指标类型:

次要指标 

Outcome:

Score of Connor-Davidson resilience scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

耳鸣主观响度

指标类型:

次要指标 

Outcome:

Subjective loudness of tinnitus

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:

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 years
最大 Max age 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):

随机数字表

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

table of random number

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2022.12.31

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

2022.12.31

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-15
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