ChiCTR1800014737 版本V1.0 版本创建时间2018/2/1 15:22:16 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:

ChiCTR1800014737 

最近更新时间:

Date of Last Refreshed on:

2018/2/1 15:20:57 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

非欺骗情境下期望对安慰剂效应和反安慰剂效应的调节机制  

Public title:

The Influence of Expectation on Non-deceptive Placebo and Nocebo effects 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

非欺骗情境下期望对安慰剂效应和反安慰剂效应的调节机制  

Scientific title:

The Influence of Expectation on Non-deceptive Placebo and Nocebo effects 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(31471082, 31671141, 31701000) 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

吕雪靖 

研究负责人:

胡理 

Applicant:

Xuejing Lu 

Study leader:

Li Hu 

申请注册联系人电话:

Applicant telephone:

+86 17801062149 

研究负责人电话:

Study leader's telephone:

+86 18310227286 

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:

luxj@psych.ac.cn 

研究负责人电子邮件:

Study leader's E-mail:

huli@psych.ac.cn 

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:

北京市朝阳区林萃路16号 

研究负责人通讯地址:

北京市朝阳区林萃路16号 

Applicant address:

16 Lincui Road, Chaoyang District, Beijing, China 

Study leader's address:

16 Lincui Road, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100101 

研究负责人邮政编码:

Study leader's postcode:

100101 

申请人所在单位:

中国科学院心理研究所 

Applicant's institution:

Institute of Psychology, Chinese Academy of Sciences 

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:

NA 

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:

西南大学心理学部伦理委员会 

Name of the ethic committee:

the Ethics Committee of Southwest University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-06-10 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

中国科学院心理研究所 

Primary sponsor:

Institute of Psychology, Chinese Academy of Sciences 

研究实施负责(组长)单位地址:

北京市朝阳区林萃路16号 

Primary sponsor's address:

16 Lincui Road, Chaoyang District, Beijing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学心理学部

具体地址:

重庆北碚区天生路2号

Institution
hospital:

Faculty of Psychology, Southwest University

Address:

2 Tiansheng Road, Beibei District, Chongqing, China

经费或物资来源:

国家自然科学基金(31471082, 31671141, 31701000) 

Source(s) of funding:

National Natural Science Foundation of China (No. 31471082, 31671141, 31701000) 

研究疾病:

疼痛 

Target disease:

pain 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

检验期望对非欺骗安慰剂和反安慰剂效应的影响程度 

Objectives of Study:

To examine the extent to which expectation influences Non-deceptive placebo and non-deceptive nocebo effects. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

右利手健康女性或男性 

Inclusion criteria

right-handed female/male healthy volunteers  

排除标准:

1.患有心血管和神经类疾病,有精神类急病史,急性或慢性疼痛,色盲,正在服用药物,以及其他不适合电刺激的情况 2.不能在条件化过程中区分电刺激的不同强度 

Exclusion criteria:

1. With cardiovascular or neurological diseases, family or personal history of psychiatric disorders, acute or chronic pain, color blindness, current use of any medication, or contraindications of electrical stimulation; 2. Unable to discriminate the distinct levels of electrical pain stimuli used in the conditioning phase.  

研究实施时间:

Study execute time:

From2018-04-13To 2019-04-13 

干预措施:

Interventions:

组别:

预期升高组

样本量:

18

Group:

increasing expectation group

Sample size:

干预措施:

通过言语诱导提高预期

干预措施代码:

Intervention:

increase expectation through verbal suggestion

Intervention code:

组别:

预期降低组

样本量:

18

Group:

decreasing expectation group

Sample size:

干预措施:

通过言语诱导降低预期

干预措施代码:

Intervention:

decrease expectation through verbal suggestion

Intervention code:

组别:

无预期组

样本量:

18

Group:

no expectation group

Sample size:

干预措施:

通过言语诱导无预期

干预措施代码:

Intervention:

no expectation through verbal suggestion

Intervention code:

组别:

基线组

样本量:

18

Group:

baseline group

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

no intervention

Intervention code:

组别:

无期望组

样本量:

40

Group:

No expectancy group

Sample size:

干预措施:

被试被告知涂抹的药物对疼痛没有任何作用

干预措施代码:

Intervention:

the skin cream was ineffective to relieve or eliminate pain

Intervention code:

组别:

低期望组

样本量:

40

Group:

Low expectancy group

Sample size:

干预措施:

被试被告知涂抹的药物能缓解疼痛感受

干预措施代码:

Intervention:

the skin cream could reduce but not eliminate pain

Intervention code:

组别:

高期望组

样本量:

40

Group:

High expectancy group

Sample size:

干预措施:

被试被告知涂抹的药物能彻底消除疼痛感受

干预措施代码:

Intervention:

the skin cream could completely eliminate pain

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

西南大学心理学部 

单位级别:

大学 

Institution
hospital:

Faculty of Psychology, Southwest University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

ratings on perceived pain intensity

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:

口头报告

组织:

Sample Name:

verbal ratings

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 24 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):

利用微软Excel 2013生成随机数列,并随机分配被试到不同的实验组

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

Experimenter used a random number producing algorithm generated by Microsoft Excel 2013 (a software available on most computer systems) to randomly allocate participants into different groups.

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

0

Data collection Institution:

资料管理单位:

邮件获取

Data management Institution:

through publication

资料分析单位:

数据通过11点疼痛评分量表(0=完全没有感觉,10=不能忍受的疼痛)采集

Data analysis Institution:

Data was collected through a 11-point numeric rating scale on the perceived pain intensity (0 = no pain at all, 10 = unbearable pain).

注册人:

Name on Registration:

 2018-01-31