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The effectiveness of pressing acupoints on the ears improves sleep quality of midlife and older women

注册号：

Registration number：

ITMCTR2023000070

最近更新日期：

Date of Last Refreshed on：

2023-12-07

注册时间：

Date of Registration：

2023-12-07

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

The effectiveness of pressing acupoints on the ears improves sleep quality of midlife and older women

Public title：

The effectiveness of pressing acupoints on the ears improves sleep quality of midlife and older women

注册题目简写：

English Acronym：

Effects of auricular acupressure on sleep quality of women

研究课题的正式科学名称：

Scientific title：

Effectiveness of auricular acupoint stimulation on modulating biomarkers to improve sleep quality of midlife and older women

研究课题的正式科学名称简写：

Scientific title acronym：

Effects of auricular acupressure on sleep quality of women

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：

研究负责人：

Applicant：

Ching-Yu Cheng

Study leader：

Ching-Yu Cheng

申请注册联系人电话：

Applicant telephone：

+886955910793

研究负责人电话：

Study leader's telephone：

+886955910793

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：

cycheng@mail.cgust.edu.tw

研究负责人电子邮件：

Study leader's E-mail：

cycheng@mail.cgust.edu.tw

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：

研究负责人通讯地址：

Applicant address：

No.2, Sec. W., Jiapu Rd., Puzi, Chiayi, Taiwan

Study leader's address：

No.2, Sec. W., Jiapu Rd., Puzi, Chiayi, Taiwan

申请注册联系人邮政编码：

Applicant postcode：

613

研究负责人邮政编码：

Study leader's postcode：

613

申请人所在单位：

Applicant's institution：

Chang Gung University of Science and Technology

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：

201702193B0

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：

Name of the ethic committee：

Chang Gung Medical Foundation Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

2018/1/30 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Shih-Hua Huang

伦理委员会联系地址：

Contact Address of the ethic committee：

199 Tung Hwa North Road, Taipei, 10507, Taiwan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+88633196200

伦理委员会联系人邮箱：

Contact email of the ethic committee：

shihhua@cgmh.org.tw

研究实施负责（组长）单位：

Primary sponsor：

National Science and Technology Council

研究实施负责（组长）单位地址：

Primary sponsor's address：

106, Sec. 2, Heping E. Rd., Taipei, Taiwan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Source(s) of funding：

National Science and Technology Council

研究疾病：

研究疾病代码：

Target disease：

sleep quality

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

半随机对照

Quasi-randomized controlled

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

Objectives of Study：

The purpose of the first-year study is to understand the experiences and needs of midlife and older women with poor sleep quality and to explore relationships between stress, fatigue, sleep quality, and biomarkers. The purpose of the second-year study is to develop a sleep promotion program. The purpose of the third-year study is to explore the effectiveness of applying auricular acupressure in improving sleep quality of midlife and older women.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

The third-year study uses intervention. Magnetic pellets are taped on auricular acupoints of the Heart, Liver, and Shenmen for the acupoint group and are taped 1-2 cm away from the acupoints for the sham group while nothing was placed on the control group. Participants were instructed to press the pellets three times a day for one month. All participants received a sleep information booklet.

纳入标准：

Inclusion criteria

1. females aged equal or over 40 years; 2. self-reported having sleep problems for over 1 month; 3. is able to attach stainless-steel pellets on ears by self or others; and 4. agreed to press on the stainless-steel pellets on ears by following the standard process.

排除标准：

Exclusion criteria：

1. taking sleeping medicines including over-the-counter products; 2. having mental or psychological disease/disorder; 3. being currently drug or alcohol-addicted; and 4. being pregnant or breastfeeding.

研究实施时间：

Study execute time：

从From 2018-02-11

至To      2021-07-31

征募观察对象时间：

Recruiting time：

从From 2021-01-13

至To      2021-06-04

干预措施：

Interventions：

组别：

样本量：

30

Group：

sham group

Sample size：

干预措施：

干预措施代码：

Intervention：

press on magnetic pellets

Intervention code：

组别：

样本量：

30

Group：

control group

Sample size：

干预措施：

干预措施代码：

Intervention：

no specific intervention

Intervention code：

组别：

样本量：

30

Group：

acupoint group

Sample size：

干预措施：

干预措施代码：

Intervention：

auricular acupressure

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Taiwan

City：

Tainan

单位(医院)：

单位级别：

Institution/hospital：

Sinying Hospital

Level of the institution：

local hospital

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

stress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

2 and 4 weeks after intervention

Measure method：

questionnaires

指标中文名：

指标类型：

主要指标

Outcome：

sleep quality

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

2 and 4 weeks after intervention

Measure method：

questionnaires

指标中文名：

指标类型：

次要指标

Outcome：

fatigue level

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

2 and 4 weeks after intervention

Measure method：

questionnaires

指标中文名：

指标类型：

主要指标

Outcome：

severity of insomnia

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

2 and 4 weeks after intervention

Measure method：

questionnaires

指标中文名：

指标类型：

次要指标

Outcome：

biomarkers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

4 weeks after intervention

Measure method：

blood sample

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

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：

征募研究对象情况：

结束

Completed

年龄范围：

最小 40 岁
Min age years
最大 85 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

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

Participants were randomly assigned to one of three groups (acupoint; sham; or control) using 1:1:1 allocation with a random block size of 6 by the principal investigator.

盲法：

Blinding：

The participants were blinded for their group; however, the Chinese medicine doctor who placed magnetic pellets on the participants' ears was not blinded.

是否共享原始数据：

IPD sharing：

否

No

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）：

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

not sharing

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：

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

Data are collected after the participants understand the research purposes, procedure, and participant rights and sign the informed consent. Returned questionnaires are stored in a locked cabinet and only the primary investigator has the key.

数据管理委员会：

Data Managemen Committee：

无

No

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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