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A Clinical Observation on the Treatment of Emotional Disorders of Stress Events by Massage on Auricular Acupuncture Points: a Randomized Controlled Trial

注册号：

Registration number：

ITMCTR2000003040

最近更新日期：

Date of Last Refreshed on：

2020-02-22

注册时间：

Date of Registration：

2020-02-22

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

耳穴按摩治疗应激事件情绪障碍的临床观察

Public title：

A Clinical Observation on the Treatment of Emotional Disorders of Stress Events by Massage on Auricular Acupuncture Points: a Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳穴按摩治疗应激事件情绪障碍的临床观察

Scientific title：

A Clinical Observation on the Treatment of Emotional Disorders of Stress Events by Massage on Auricular Acupuncture Points

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：

ChiCTR2000030078 ; ChiMCTR2000003040

申请注册联系人：

何家恺

研究负责人：

荣培晶

Applicant：

He Jiakai

Study leader：

Rong Peijing

申请注册联系人电话：

Applicant telephone：

+86 13774669640

研究负责人电话：

Study leader's telephone：

+86 13718482149

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：

hejacky.jay@qq.com

研究负责人电子邮件：

Study leader's E-mail：

drrongpj@163.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：

中国北京市东城区东直门内南小街16号

研究负责人通讯地址：

中国北京市东城区东直门内南小街16号

Applicant address：

16 Dongzhimen Inner Street South, Dongcheng District, Beijing, China

Study leader's address：

16 Dongzhimen Inner Street South, Dongcheng District, Beijing, 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：

中国中医科学院针灸研究所

Applicant's institution：

Institute of Acupuncture and Moxibustion, Chinese Academy of traditional Chinese Medicine

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：

中科针伦（2020-02-17）

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：

中国中医科学院针灸研究所伦理委员会

Name of the ethic committee：

Ethics Committee of Institute of acupuncture and moxibustion, Chinese Academy of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/2/17 0:00:00

伦理委员会联系人：

李宇清

Contact Name of the ethic committee：

LI Yuqing

伦理委员会联系地址：

中国北京市东城区东直门内南小街16号

Contact Address of the ethic committee：

16 Dongzhimen Inner Street South, Dongcheng District, Beijing, 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：

zhenjslunli@163.com

研究实施负责（组长）单位：

中国中医科学院针灸研究所

Primary sponsor：

Institute of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国北京市东城区东直门内南小街16号

Primary sponsor's address：

16 Dongzhimen Inner Street South, Dongcheng 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)：

北京市

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng District

单位(医院)：

中国中医科学院针灸研究所

具体地址：

东直门内南小街16号

Institution
hospital：

Institute of acupuncture and moxibustion, Chinese Academy of traditional Chinese Medicine

Address：

16 Dongzhimen Inner Street South

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

创伤后应激障碍

研究疾病代码：

Target disease：

Post-traumatic stress disorder

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：

1. 确定耳穴按摩是否可缓解因Corona Virus Disease-2019(COVID-19)疫情而居家隔离所引起的焦虑抑郁症状及其它精神症状； 2. 评估与非严格隔离人群相比，长时间严格隔离造成的焦虑抑郁和其它精神症状是否更严重。

Objectives of Study：

1. To determine whether massage on auricular acupuncture points can alleviate anxiety, depression and other mental symptoms caused by isolation at home due to corona virus disease-2019 (COVID-19) epidemic. 2. To evaluate whether anxiety, depression and other mental symptoms caused by long-term strict isolation are more serious than those caused by non-strict isolation.

药物成份或治疗方案详述：

1. 耳穴按摩结合健康教育组（甲组） （1）耳穴按摩（图1）包括： a. 蛟龙捣海（按摩耳甲腔）：两手中指横放伸直，伸入耳甲腔，指尖（肌肤）按压在耳甲腔后缘，余四指握拳，拳心向后，中指顺时针方向在耳甲腔按摩半圈，这一动作配合吸气。接着，中指由耳甲腔后缘，逆时针方向在耳甲腔按摩半圈，这一动作配合呼气。向顺、逆时针方向各按摩8次，配合呼吸。 b. 天池荡舟（按摩耳甲艇）：两手食指伸入耳甲艇，食指尖（肌肤）按压在耳甲艇后缘，余四指握拳，拳心向后；然后食指由外下向内上推进，由下而上，按摩耳甲艇半圈，这一动作配合吸气。接着，食指微屈，由内上向外下，由内而外，按摩耳甲艇半圈，这一动作配合呼气。上下按摩8次。 c. 喜鹊点头（按摩耳穴）：穴位包括神门、皮质下、枕、胃。每个穴位按摩1分钟，配合呼吸，顺时针配合吸气，逆时针配合呼气，双耳各穴同时按摩。 上述3步操作，每日3次，早中晚各1次。 健康教育 1) 做好防护，避免感染。 对于COVID-19此种大型疫疠，应远离可能的传染环境，远离人群聚集的场合，尽量减少外出活动，做好隔离防护措施，科学、规范的进行个人防护，正确佩戴医用外科口罩或N95口罩，在咳嗽打喷嚏后、准备食物、用餐前、出入公共场合后正确洗手。注意定期更换口罩，医用外科口罩应符合《医用外科口罩》（YY0469-2011）标准，医用防护口罩应符合《医用防护口罩技术要求》（GB19083-2010）标准。 2) 做好体温监测，尽量避免乘坐公共交通工具。 家中备好体温计，自觉发热时主动监测体温，若出现可疑症状，避免过度紧张，根据病情规范就医。就医时佩戴口罩，尽量避免乘坐地铁、公共汽车等公共交通，就诊时主动告知疫区接触史，及密切接触者。 3) 了解COVID-19不恐慌 出现发热、咳嗽先不要过度紧张。从目前收治的病例来看，多数患者预后良好。 4) 调节情绪 学习呼吸养生法，调节气息以缓解紧张焦虑情绪。 a. 吸气：吸一口气到小腹，根据自己身体情况，可浅吸，可深吸。 b. 闭气：然后开始闭气，根据自己身体情况，可久闭，可短闭。 c. 养气：在闭气的过程中，观想吸进来的这团空气，吸入抵达小腹时，转化变成了一团能量，被你的小腹所吸收。 d. 呼气：最后轻松、自然、缓慢地呼气。 注意事项：呼气与吸气都只用鼻子。 不要过度关注COVID-19相关的信息，避免信息轰炸引起恐慌。多看窗外绿色植物，多听舒缓音乐。 5) 调节睡眠 每天坚持固定的时间上床睡觉，坚持每天早起，在保证充足睡眠的同时不断地强化自己早睡早起的生物钟。 睡觉之前尽量避免胡思乱想，每天要确保睡眠环境是好的，睡觉之前最好将卧室的窗帘拉上，窗帘最好是厚的，可以阻挡夜晚的灯光、月光。睡觉的时候要将全部的光源都关掉，让自己处于一个安静的、黑暗的环境中，这样才可以让你睡一个好觉。 6) 调节饮食 湿邪困脾，在饮食防护方面应做到饮食清淡。平时嗜食肥甘厚味的朋友，在疫情发展期间尽量忌口，以免湿邪内生，影响脾胃功能；平素脾胃虚寒的患者，此时更应杜绝一切生冷食物，包括生冷的蔬菜和水果。在饮食习惯上，做到三餐规律，避免过饱。更不要接触、购买和食用野生动物（野味）。 7) 适度运动，运动使人快乐。 热身运动进行3-5分钟准备活动，如原地慢跑、蹲起、徒手操等低强度热身运动及肌肉拉伸练习，提升身体状态，避免运动损伤。根据个人体质将运动时长控制在每天一小时左右，可以选择30分钟在室内走动、做做高抬腿等动作；30分钟做拉伸，以及深蹲、俯卧撑、仰卧起坐等运动。 居家锻炼要注意安全，检查好锻炼环境，做好安全防范，避免磕碰。在运动中，还要注意室内通风。在家健身也要做好运动前的热身，运动后的整理。 2. 健康教育组（乙组） 健康教育：具体内容同甲组的“（2）健康教育”部分。

Description for medicine or protocol of treatment in detail：

1.Massage on auricular acupuncture points combined with health education group(Group A500) (1)Massage on auricular acupuncture points: 1)Dragon pounding the sea (massage on the inferior concha): extend the middle fingers of both hands horizontally and straightly into the ear cavity, press the fingertips (skin) on the back edge of the ear cavity, clench the remaining four fingers, and massage the middle fingers in the ear cavity for half a circle in a clockwise direction. This action cooperates with inhalation. Next, the middle finger comes back to the posterior edge of the concha cavity anticlockwise for half a circle. This action is combined with exhaling. Massage 8 times in clockwise and counter clockwise direction respectively, cooperate with breathing. 2)Tianchi boating (massage on the superior concha): put two forefingers into the supeiror concha, press the tip of forefinger (skin) on the back edge of the supeiror concha, clench the rest four fingers, and the heart of the fist is backward; then push the forefinger from the outside (down) to the inside (up), and massage the supeiror concha for half a circle from the bottom up. This action cooperates with inhalation. Then, slightly bend the index finger, from the inside (up) to the outside(down), and massage the supeiror concha for half a circle from the top down. This action cooperates with exhalation. Massage up and down 8 times. 3)Magpie nods (massage on auricular acupuncture points): the points include Shenmen, subcortical, occiput and stomach. Massage each point for 1 minute, cooperate with breathing, inhalation with massage clockwise, and exhalation with massage counterclockwise. Massage each point of both ears at the same time. The above-mentioned three-step operation, three times a day, one in the morning, one at noon and one in the evening. (2)Health education 1)Protect against infection:As for covid-19, it is necessary to keep away from the possible infectious environment and the places where people gather, to minimize going out, to take isolation and protection measures, to carry out personal protection scientifically and normatively, to correctly wear medical surgical masks or N95 masks, to wash hands correctly after coughing and sneezing, preparing food, before eating and after going out of public places. Pay attention to the regular replacement of masks. The medical surgical masks shall meet the standards of medical surgical masks (YY0469-2011), and the medical protective masks shall meet the standards of technical requirements for medical protective masks (GB19083-2010). 2)Do a good job in temperature monitoring and try to avoid taking public transportation:Prepare a thermometer at home and take the initiative to monitor the temperature when you feel fever. In case of suspicious symptoms, avoid over tension and seek medical treatment according to the condition. Wear a mask when seeking medical treatment, try to avoid taking subway, bus and other public transportation, and actively inform the contact history of the epidemic area and close contacts when seeking medical treatment. 3)Understand covid-19 and don't panic:If you have fever or cough, don't be too nervous. From the current cases, most patients have a good prognosis. 4)Regulate emotions:Learn breathing regimen and regulate breath to relieve tension and anxiety:a. Inhale: take a breath to the abdomen. According to your body condition, you can take a shallow breath or a deep one.b. Shut up: then start to shut down. According to your physical condition, you can shut down for a long time or for a short time.c. Nourishing: in the process of closing breath, visualizing the air inhaled, when inhaled to the lower abdomen, it turns into a mass of energy, which is absorbed by your lower abdomen.d. Exhale: finally exhale easily, naturally and slowly.Note: use only the nose when exhaling and inhaling.Don't pay too much attention to covid-19 related information to avoid information bombing causing panic. Enjoy the green plants and listen to soothing music. 5)Regulate sleep:Go to bed at a fixed time every day, get up early every day, and constantly strengthen your biological clock of early to bed and early to rise while ensuring adequate sleep.Before going to bed, try to avoid daydreaming. Every day, make sure that the sleeping environment is good. Before going to bed, it's best to close the curtains in the bedroom. The curtains should be thick, which can block the lights and moonlight at night. When you sleep, you should turn off all the light sources and keep yourself in a quiet and dark environment, so that you can have a good sleep. 6)Regulate diet:Dampness traps the spleen, so the diet should be bland. Usually, participants who are fond of eating fat, sweet and thick taste should avoid eating as much as possible during the development of the epidemic situation, so as to avoid the internal generation of damp pathogens and affect the function of the spleen and stomach; for patients with deficiency cold of the spleen and stomach, all raw and cold food, including raw and cold vegetables and fruits, should be put an end to at this time. As for eating habits, three meals should be done regularly to avoid over satiety. Don't touch, buy or eat wild animals. 7)Proper exercise makes people happy:Warm up for 3-5 minutes, such as jogging in situ, squatting, barehanded exercises and other low-intensity warm-up exercises and muscle stretching exercises, to improve the body state and avoid sports injury. According to personal constitution, exercise duration is controlled at about one hour every day. You can choose to walk indoors for 30 minutes, do high leg lifting and other actions; stretch for 30 minutes, and squat, push ups, sit ups and other sports.Home exercise should pay attention to safety, check the exercise environment, do a good job of safety precautions, avoid bumps. In sports, also pay attention to indoor ventilation. Do a good job of warm-up before and after exercise. 2.Health Education (Group B500) The content is the same as health education.

纳入标准：

（1）18至75周岁； （2）常住居民（调研时当地居住至少半年）； （3）医院焦虑抑郁量表得分≥9。

Inclusion criteria

1. Aged 18 to 75 years; 2. Permanent residents (at least half a year for local residents at the time of survey); 3. Hospital Anxiety and Depression Scale score >= 9 points.

排除标准：

（1）严重的神经、精神系统疾病； （2）严重的呼吸、循环、消化、泌尿、内分泌等系统基础病； （3）PHQ-9 抑郁量表得分为≥20分； （4）其它各种原因无法配合完成量表。

Exclusion criteria：

1. Serious neurological and mental system diseases; 2. Serious basic diseases of respiratory, circulatory, digestive, urinary and endocrine systems; 3. PHQ-9 Depression Scale score >= 20 points; 4. For other reasons, who can not complete the scales.

研究实施时间：

Study execute time：

从From 2020-02-17

至To      2020-06-30

征募观察对象时间：

Recruiting time：

从From 2020-02-17

至To      2020-06-30

干预措施：

Interventions：

组别：

对照组

样本量：

204

Group：

control group

Sample size：

干预措施：

健康教育

干预措施代码：

Intervention：

health education

Intervention code：

组别：

试验组

样本量：

204

Group：

experimental group

Sample size：

干预措施：

耳穴按摩及健康教育

干预措施代码：

Intervention：

Massage on auricular acupuncture points combined with health education

Intervention code：

样本总量 Total sample size ： 408

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

辽宁

市(区县)：

沈阳

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

辽宁中医药大学

单位级别：

大学

Institution/hospital：

Liaoning University of Traditional Chinese Medicine

Level of the institution：

University

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

武汉市第一医院

单位级别：

三级甲等

Institution/hospital：

Wuhan NO.1 Hospital

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属同济医院

单位级别：

三级甲等

Institution/hospital：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院

单位级别：

国家中医药管理局直属机构

Institution/hospital：

Institute of acupuncture and moxibustion, Chinese Academy of traditional Chinese Medicine

Level of the institution：

Institutions directly under the State Administration of Traditional Chinese Medicine

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州中医药大学

单位级别：

大学

Institution/hospital：

Guangzhou University of Chinese Medicine

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

贝克焦虑量表

指标类型：

次要指标

Outcome：

Baker anxiety scale

Type：

Secondary indicator

测量时间点：

治疗前、完成第3天治疗后、第14天治疗后。

测量方法：

量表评估

Measure time point of outcome：

Day0, Day3, Day14

Measure method：

Scale assessment

指标中文名：

医院焦虑抑郁量表

指标类型：

主要指标

Outcome：

Hospital Anxiety and Depression Scale

Type：

Primary indicator

测量时间点：

治疗前、完成第3天治疗后、第14天治疗后。

测量方法：

量表评估

Measure time point of outcome：

Day0, Day3, Day14

Measure method：

Scale assessment

指标中文名：

HQ-9抑郁症量表

指标类型：

次要指标

Outcome：

PHQ-9 depression screening scale

Type：

Secondary indicator

测量时间点：

治疗前、完成第3天治疗后、第14天治疗后

测量方法：

量表评估

Measure time point of outcome：

Day0, Day3, Day14

Measure method：

Scale assessment

指标中文名：

事件影响量表

指标类型：

次要指标

Outcome：

The impact emergent scale-revised

Type：

Secondary indicator

测量时间点：

治疗前、完成第3天治疗后、第14天治疗后。

测量方法：

量表评估

Measure time point of outcome：

Day0, Day3, Day14

Measure method：

Scale assessment

指标中文名：

睡眠情况

指标类型：

次要指标

Outcome：

sleep situation

Type：

Secondary indicator

测量时间点：

治疗前、完成第3天治疗后、第14天治疗后

测量方法：

睡眠日记

Measure time point of outcome：

Day0, Day3, Day14

Measure method：

Sleep diary

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
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）：

由中国中医科学研制本研究专用微信小程序，受试者入组时，由中央系统随机生成随机号

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

A WeChat program dedicated to this subject was developed by CACMS；A random number was randomly generated by the central system When the subjects entered the group.

盲法：

未说明

Blinding：

Not stated

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）：

ResMan

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

ResMan

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：

CRF

数据管理委员会：

Data Managemen Committee：

有

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):

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