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自摩腹法对失眠症的疗效:随机对照试验研究
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注册号:

Registration number:

ChiCTR1900028009 

最近更新日期:

Date of Last Refreshed on:

2019-12-19 

注册时间:

Date of Registration:

2019-12-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

自摩腹法对失眠症的疗效:随机对照试验研究 

Public title:

Effectiveness of self-abdomen-rubbing therapy for insomnia: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自摩腹法对失眠症的疗效:随机对照试验研究 

Scientific title:

Effectiveness of self-abdomen-rubbing therapy for insomnia: 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:

ChiMCTR1900002818 

申请注册联系人:

管翀 

研究负责人:

姚斐 

Applicant:

Guan Chong 

Study leader:

Yao Fei 

申请注册联系人电话:

Applicant telephone:

+86 19921307807 

研究负责人电话:

Study leader's telephone:

+86 13585975106 

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:

sanchiweiming@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doctoryaofei@126.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:

上海市蔡伦路1200号 

研究负责人通讯地址:

上海市蔡伦路1200号 

Applicant address:

1200 Cailun Road, Pudong New District, Shanghai, China 

Study leader's address:

1200 Cailun Road, Pudong New District, Shanghai, 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:

上海中医药大学 

Applicant's institution:

Shanghai University of Traditional Chinese Medicine 

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:

2019-106 

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:

上海中医药大学附属岳阳中西医结合医院伦理审查委员会 

Name of the ethic committee:

Regional Ethics Review Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-09 

伦理委员会联系人:

殷从全 

Contact Name of the ethic committee:

Yin Congquan 

伦理委员会联系地址:

上海市虹口区甘河路110号 

Contact Address of the ethic committee:

110 Ganhe Road, Hongkou District, Shanghai, 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:

上海中医药大学 

Primary sponsor:

Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District

经费或物资来源:

国家自然科学基金委员会 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

失眠 

Target disease:

insomnia 

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:

1. 观察摩腹组及行为认知组治疗慢性失眠的临床疗效及脑肠肽水平的变化,为摩腹治疗慢性失眠提供客观依据,进一步扩展慢性失眠的治疗方法。 2. 在临床疗效研究的基础上,运用静息态功能磁共振成像技术,通过对比治疗前后患者脑区激活区域大小,试探讨摩腹治疗失眠的中枢机制,为摩腹治疗失眠的临床应用提供科学的可视化依据。 

Objectives of Study:

1. Observe the clinical effect of abdominal massage group and behavioral cognition group on the treatment of chronic primary insomnia and the changes of brain gut peptide level, provide objective basis for the treatment of chronic primary insomnia with abdominal massage group, and further expand the treatment of chronic primary insomnia. 2. On the basis of clinical efficacy studies, resting state functional magnetic resonance imaging (fMRI) technology was used to compare the size of activated brain regions of patients before and after treatment to explore the central mechanism of abdominal massage in the treatment of insomnia, so as to provide scientific visualization basis for the clinical application of abdominal massage in the treatment of insomnia. 

药物成份或治疗方案详述:

“摩腹法”是本课题组参照全国普通高等中医药类精编教材《推拿功法学》“延年九转法”干预方案和操作标准相关内容,经过相应的简化和修改而成。制作标准视频,功法录音。 每周于岳阳医院推拿所功法研究中心或上海中医药大学练功房集中训练一次,自行在家练习六次。在首次集中练习时给与患者配合摩腹法练习的音频、视频文件,供患者自行在家练习。患者被要求每日晚间卧床后,按照相关音频进行练习,每次练习时间约30分钟。 所有患者在治疗和检测时,腹部均统一铺盖治疗巾。女性患者如在治疗在遇到月经期,可向后顺延3日。 摩腹法具体操作方法如下: 第一式:以两手中三指按心窝,由左顺摩圆转21次。 第二式:以两手中三指由心窝顺摩而下,且摩且走,摩至脐下高骨为度。 第三式:以两手中三指由高骨处向两边分摩而上,且摩且走,摩至心窝。两手交接为度。 第四式:以两手中三指由心窝由下,直推至高骨,共21次。 第五式:以右手由左绕摩脐腹21次。 第六式:以左手由右绕摩脐腹21次。 第七式:左手置左边软肋下腰肾处,大指向前,四指托后,轻轻捏定;右手中三指自左乳下直推至腹股沟21次。 第八式:右手置右边软肋下腰肾处,大指向前,四指托后,轻轻捏定;左手中三指自右乳下直推至腹股沟21次。 第九式:双手掌心平置于腹部,深呼吸21次。 质量控制方案 患者入组后,由医生作为期3天的摩腹培训和刺激量标定,摩腹的刺激量均值(0.5±0.1)kg。试验开始后每周集中安排带教1次,其余6次患者按标准视频自行操作,及时填写操作记录本并线上传给质量控制负责人。 

Description for medicine or protocol of treatment in detail:

Self-abdominal-rubbing group: In this arm of the study, insomnia patient will receive self-abdominal-rubbing therapy for 30 minutes, seven times a week for a total eight weeks. The patients concentrate practicing once a week and exercising on their own at home 6 times for about 30 minutes each time, From Monday to Saturday. The patients lay flat on the bed and rubbed their stomach once a day. In order to ensure correct posture, strength and speed of movement, patients are required to participate in exercises led by qualified massage doctors in the training room of Shanghai university of Chinese medicine every Sunday. The patients were asked to practice lying flat on the bed before going to bed. Step 1: the patient presses three fingers (index finger, middle finger and ring finger) in the Juque acupoint in two hands. Under the cooperative action of shoulder, elbow, forearm and wrist, the patient makes a small clockwise circular rotation movement and causes the skin of the operative part to rotate together. Knead 21 times. Step 2: the patient presses three fingers (index finger, middle finger and ring finger) in two hands to the position of Jiuwei acupoint, knead clockwise and move slowly downward to the position of Qugu acupoint for a total of 21 times. Step 3: with two hands 3 point by pubic symphysis place to both sides depart, at doing loop to turn rub move while, along abdomen both sides move up to rib edge, massage to Juque again next cave position, massage 21 times in all. Step 4: with two hands three fingers (index finger, middle finger, ring finger) from the smell of mutton in the hole, straight down to Qugu hole, a total of 21 times; Step 5: press the palm of the right hand on the abdomen and rub it in a clockwise direction with a certain rhythm for 21 times. Step 6: press the palm of the left hand on the abdomen, and do the circular rubbing in the direction of counterclockwise in a certain rhythm for 21 times. Step 7: with the right hand middle three fingers (index finger, middle finger, ring finger), from left breast bottom (root of milk) rub to return point 21 times. Step 8: with left hand medium 3 fingers (index finger, middle finger, ring finger), from right breast bottom (lactation root hole) rub move arrive return hole 21. Step 9: Position your hands flat on your stomach and take 21 deep breaths. The above nine steps are recorded as one, and the movements are repeated three times. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 符合ICSD-3失眠诊断标准者; 2. ISI量表评分在≥8分且≤21分; 3. 年龄≥20周岁且≤45周岁,性别不限; 4. 汉密尔顿抑郁量表(HAMD) ≤14分; 5. 过去1月内未接受过任何关于治疗失眠的治疗方案,包括西药、成药、方药、中成药及汤剂、针灸等; 6. 血常规和肝肾功能未见异常; 7. 右利手; 8. 理解、同意参加本研究并签署知情同意书。 

Inclusion criteria

1. Those meeting ICSD-3 criteria for diagnosis of insomnia; 2. ISI scale score was >= 8 and <=21; 3. Aged >= 20 and <= 45, regardless of gender; 4. HAMD <= 14 points; 5. Did not receive any treatment plan for insomnia in the past 1 month, including western medicine, proprietary medicine, traditional Chinese medicine, decoction, acupuncture, etc.; 6. Blood routine and liver and kidney functions were not abnormal; 7. Right-handed; 8. Understand and agree to participate in this study and sign the informed consent. 

排除标准:

有下列任何一种情况的参与者将被排除在本次试验之外: 1. 患有重度抑郁障碍、焦虑障碍、恐慌障碍或其他精神障碍、酒精或咖啡因成瘾的人; 2. 工作原因影响昼夜节律; 3. 严重的疼痛足以引起睡眠障碍或可能引起失眠的疾病; 4. 没有足够的语言能力和活动能力来进行腹部按摩; 5. 严重或全身性疾病(内分泌系统疾病、运动系统疾病、自身免疫性疾病、感染性疾病、糖尿病等代谢性疾病)影响睡眠; 6. 有金属史,头部手术,植入任何金属或其他功能磁共振禁忌症。7. 怀孕、哺乳或计划怀孕。 

Exclusion criteria:

Participants with any one of the following conditions will be exclude from this trial: 1. People with major depressive disorder, anxiety disorder, panic disorder or other mental disorder, alcohol or caffeine addiction; 2. Work causes affect circadian rhythm; 3. Severe pain enough to cause sleep disturbances or diseases that may cause insomnia; 4. Not enough language ability and activity ability to perform abdominal massage; 5. Patients with severe or systemic diseases (endocrine system diseases, sports system diseases, autoimmune diseases, infectious diseases, diabetes and other metabolic diseases) affect sleep; 6. Have a history of metal, surgery on the head, implant any metal or other fmri contraintion; 7. Get pregnant, breast-feed, or plan to get pregnant. 

研究实施时间:

Study execute time:

From2020-01-31To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-01-31To 2020-12-31 

干预措施:

Interventions:

组别:

自摩腹组

样本量:

57

Group:

Self-abdominal-rubbing group

Sample size:

干预措施:

自摩腹法

干预措施代码:

Intervention:

Self-abdominal-rubbing

Intervention code:

组别:

行为认知疗法组

样本量:

57

Group:

CBT-I group

Sample size:

干预措施:

行为认知疗法

干预措施代码:

Intervention:

CBT-I

Intervention code:

组别:

健康人组

样本量:

15

Group:

health people group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

失眠严重程度量表

指标类型:

主要指标 

Outcome:

Insomnia Severity Index

Type:

Primary 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

指标类型:

次要指标 

Outcome:

Pittsburgh sleep quality index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

健康调查简表

指标类型:

次要指标 

Outcome:

he MOS item short from health survey

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑抑郁量表

指标类型:

次要指标 

Outcome:

Hospital Anxiety and 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:

5-羟色胺

指标类型:

次要指标 

Outcome:

5-hydroxytryptamine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经肽

指标类型:

次要指标 

Outcome:

neuropeptide Y

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活性物质

指标类型:

次要指标 

Outcome:

substance P

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管活性肠肽

指标类型:

次要指标 

Outcome:

vasoactive intestinal peptide

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静息态功能磁共振

指标类型:

次要指标 

Outcome:

resting-state functional MRI

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:

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:

静息态功能磁共振

组织:

Sample Name:

resting-state functional MRI

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 45 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):

合格的参与者将被随机分配到任何一组,比例为1:1。 随机数字表将由与参与者或评估人员没有直接接触的研究人员进行,以获得治疗程序和结果。 随机数字将密封在一个预先确定的随机不透明信封。 患者的筛查序列号将打印在信封的外面,组名将打印在里面。 在每个病人验证合格并签署书面知情同意书后,将立即打开一个包含每个病人指定序列号的信封。 (SPSS 24.0, SPSS Inc,芝加哥,伊利诺伊州,美国) 随机化将分两个步骤进行: (1) 112例患者平均分为两组; (2)每组随机选取15例患者进行fMRI扫描。 我们将使用一个不透明的密封信封来隐藏序列,直到分配了一个干预。

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

Eligible participants will be randomly assigned to either group in a 1:1 ratio. The random number table will be conducted by researchers who have no direct contact with the participants or evaluators to obtain treatment procedures and results.

盲法:

由于推拿疗法与CBTI之间存在显著差异,无论是实验者还是病人都不能施盲。 但是我们要确保负责统计分析的人不知道病人的分组和干预措施。

Blinding:

Because of the significant differences between massage therapy and CBTI, neither the experimenter nor the patient could go blind. But we're going to make sure that the people who are responsible for the statistical analysis don't know the grouping of patients and the intervention.

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

是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):

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

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

Within 6 months after the trial complete

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:

原始数据,电子CRF

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

原始数据,电子CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-08
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