Clinical Application of Moxibustion, Acupuncture and Insomnia Therapeutic Apparatus in Treating Adolescent Insomnia with Anxiety and Depression

注册号:

Registration number:

ITMCTR2025000057

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

艾灸、针灸联合失眠治疗仪治疗青少年失眠伴焦虑抑郁状态的临床应用

Public title:

Clinical Application of Moxibustion, Acupuncture and Insomnia Therapeutic Apparatus in Treating Adolescent Insomnia with Anxiety and Depression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

艾灸、针灸联合失眠治疗仪治疗顽固性失眠的临床应用

Scientific title:

Clinical application of moxibustion acupuncture combined with insomnia therapeutic instrument in the treatment of intractable insomnia

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:

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:

姚均超

研究负责人:

孙慧丽

Applicant:

Yao Jun Chao

Study leader:

Sun Hui Li

申请注册联系人电话:

Applicant telephone:

17712981711

研究负责人电话:

Study leader's telephone:

13705209531

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:

18795860759@163.com

研究负责人电子邮件:

Study leader's E-mail:

1849034020@qq.com

申请单位网址(自愿提供):

Study leader's 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:

江苏省徐州市铜山区大学路269号

研究负责人通讯地址:

江苏省徐州市铜山区大学路269号

Applicant address:

No.269 Daxue Road tongshan district Xuzhou City Jiangsu Province

Study leader's address:

No.269 Daxue Road tongshan district Xuzhou City Jiangsu Province

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:

徐州市第一人民医院中医科

Applicant's institution:

Department of traditional Chinese medicine of Xuzhou first people's hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

xyyll[2024]-XJSFX-126

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

徐州市第一人民医院伦理委员会

Name of the ethic committee:

Ethics Committee of Xuzhou First People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/7 0:00:00

伦理委员会联系人:

李泳

Contact Name of the ethic committee:

Li Yong

伦理委员会联系地址:

江苏省徐州市铜山区大学路269号

Contact Address of the ethic committee:

No.269 Daxue Road tongshan district Xuzhou City Jiangsu Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

0516-68167579

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xyykjc@163.com

研究实施负责(组长)单位:

徐州市第一人民医院中医科

Primary sponsor:

Department of traditional Chinese medicine of Xuzhou first people's hospital

研究实施负责(组长)单位地址:

徐州市第一人民医院中医科

Primary sponsor's address:

Department of traditional Chinese medicine of Xuzhou first people's hospital

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏省

市(区县):

徐州市

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州市第一人民医院中医科

具体地址:

江苏省徐州市铜山区大学路269号

Institution
hospital:

Department of traditional Chinese medicine of Xuzhou first people's hospital

Address:

No.269 Daxue Road tongshan district Xuzhou City Jiangsu Province

经费或物资来源:

自筹

Source(s) of funding:

self-finance

研究疾病:

顽固性失眠

研究疾病代码:

Target disease:

intractable insomnia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

探讨艾灸、针灸联合失眠治疗仪治疗顽固性失眠的疗效,探索更健康、经济的联合治疗方案,减少患者因顽固性失眠造成的痛苦,减轻经济负担。规范科室中医科与心理科的合作模式,推广针对顽固性失眠等疾病的更加安全有效的治疗方式,提高临床疗效,让更多患者受益。

Objectives of Study:

To explore the curative effect of moxibustion and acupuncture combined with insomnia therapeutic instrument on intractable insomnia and explore a healthier and more economical combined treatment scheme to reduce the pain caused by intractable insomnia and reduce the economic burden. Standardize the cooperation mode between traditional Chinese medicine and psychology department promote safer and more effective treatment methods for intractable insomnia and other diseases improve clinical efficacy and benefit more patients.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

病程≥2年;年龄在15-75岁之间;符合西医的慢性失眠诊断标准;PSQI总分在入组时>7分;伴随焦虑症状,SAS评分在入组时>40分;自愿参加并签署知情同意书。

Inclusion criteria

The course of disease is ≥2 years; Age is between 15 and 75 years old; Meet the diagnostic criteria of chronic insomnia in western medicine; The total score of PSQI was > 7 when joining the group; With anxiety symptoms SAS score was > 40 when entering the group; Voluntary participation and signing of informed consent.

排除标准:

近4周服用除艾司唑仑以外具有镇静安眠作用药物者;合并严重的肝脏、肾脏、心脑血管等功能不全或者其他系统的疾病者;失眠是由于昼夜节律颠倒、夜班等引发的;存在酗酒,存在精神类物质或药物的滥用或者依赖;处于备孕期、妊娠期或者哺乳期;无法配合针刺或者药物治疗者。

Exclusion criteria:

Those who have taken drugs with sedative and hypnotic effects except estazolam in the last 4 weeks; Complicated with severe liver kidney cardiovascular and cerebrovascular dysfunction or other system diseases; Insomnia is caused by the reversal of circadian rhythm and night shift. There is alcoholism abuse or dependence of psychotropic substances or drugs; In preparation for pregnancy pregnancy or lactation; Unable to cooperate with acupuncture or drug treatment.

研究实施时间:

Study execute time:

From 2024-04-07

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-04-08

To      2025-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

25

Group:

control group

Sample size:

干预措施:

口服艾司唑仑片

干预措施代码:

Intervention:

Oral estazolam tablets

Intervention code:

组别:

治疗组

样本量:

25

Group:

treatment group

Sample size:

干预措施:

艾灸、针灸、失眠治疗仪、口服艾司唑仑片

干预措施代码:

Intervention:

moxibustion、acupuncture、Insomnia therapeutic apparatus 、Oral estazolam tablets

Intervention code:

样本总量 Total sample size : 50

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏省

市(区县):

徐州市

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州市第一人民医院

单位级别:

三级甲等

Institution/hospital:

Xuzhou First People's Hospital

Level of the institution:

grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

中医证候积分

指标类型:

次要指标

Outcome:

traditional chinese medicine(TCM) syndrome score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标

Outcome:

Self-rating anxiety 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:

失眠严重程度指数量表

指标类型:

次要指标

Outcome:

Insomnia severity index 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:

疲劳量表

指标类型:

次要指标

Outcome:

Fatigue 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:

抑郁自评量表

指标类型:

次要指标

Outcome:

Self-rating depression 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:

匹兹堡睡眠质量指数量表

指标类型:

主要指标

Outcome:

Pittsburgh Sleep Quality Index Scale

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:

粪便

组织:

Sample Name:

Defecation

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

正在进行

Recruiting

年龄范围:

最小 15
Min age years
最大 25
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

姚均超运用SPSS 25.0软件产生随机数字并进行完全随机分组

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

Yao Junchao used SPSS 25.0 software to generate random numbers and completely random group them.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

科研论文发表之后,联系研究者电子邮件获取

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

After the publication of research papersObtained by email from the researcher

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above