ChiCTR2100043804 版本V1.0 版本创建时间2021/06/27 22:50:05 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：

 ChiCTR2100043804 

最近更新日期：

Date of Last Refreshed on：

 2021-03-03 02:06:54 

注册时间：

Date of Registration：

 2021-03-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

减少心理应激和改善新生儿结果的线上围产期正念干预的随机对照试验

Public title：

A Digital Prenatal Mindfulness-Based Program for Reducing Psychological Stress and Improving Neonatal Outcomes: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

减少心理应激和改善新生儿结果的线上围产期正念干预:随机对照试验

Scientific title：

A Digital Perinatal Mindfulness-Based Program for Reducing Psychological Stress and Improving Neonatal Outcomes: 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：

申请注册联系人：

冷玲莉 

研究负责人：

冷玲莉 

Applicant：

LINGLI LENG 

Study leader：

LINGLI LENG 

申请注册联系人电话：

Applicant telephone：

 +86 13534143125

研究负责人电话：

Study leader's
telephone：

+86 13534143125

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：

 LINGLILENG@GMAIL.COM

研究负责人电子邮件：

Study leader's E-mail：

 LINGLILENG@GMAIL.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：

Social work and social administration department, the University of Hong Kong, Hong Kong, China

研究负责人通讯地址：

Social work and social administration department, the University of Hong Kong, Hong Kong, China

Applicant address：

Social work and social administration department, the University of Hong Kong, Hong Kong, China

Study leader's address：

Social work and social administration department, the University of Hong Kong, Hong Kong, 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：

香港大學

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

香港大學

Affiliation of the Leader：

The University of Hong Kong

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：

 EA1904036

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：

Hong Kong University Human Research Ethics Committee

Name of the ethic committee：

Hong Kong University Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Professor Scott Veitch

Contact Name of the ethic committee：

Professor Scott Veitch

伦理委员会联系地址：

Secretary, Human Research Ethics Committee, c/o Research Services of the Registry, 9/F Knowles Building, the University of Hong Kong, China

Contact Address of the ethic committee：

Secretary, Human Research Ethics Committee, c/o Research Services of the Registry, 9/F Knowles Building, the University of Hong Kong, 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：

None

Primary sponsor：

None

研究实施负责（组长）单位地址：

None

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Self-financed

Source(s) of funding：

Self-financed

研究疾病：

Perinatal stress, depression and anxiety symptoms  

Target disease：

Perinatal stress, depression and anxiety symptoms

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：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Present research is to develop and evaluate a prenatal mindfulness intervention for reducing psychological stress and improving neonatal outcomes among Chinese pregnant women. The objectives of study are: 1. To evaluate the efficacy of the proposed intervention in terms of the changes of process outcome variables including trait mindfulness and equanimity at T1 & T2; 2. To evaluate the efficacy of the intervention in terms of the changes of primary outcomes variable including general and pregnant related stress at T1 & T2; 3. To evaluate the efficacy of the intervention in terms of the changes of secondary outcome variables including depression, anxiety, stress coping, satisfaction with life and self-compassion at T1 & T2; 4. To examine the trajectory of general and pregnant related stresses in relation to obstetric and neonatal outcomes after participants have giving birth; 5. To evaluate the effect of process outcome variables on mediating primarily outcome variables.  

Objectives of Study：

Present research is to develop and evaluate a prenatal mindfulness intervention for reducing psychological stress and improving neonatal outcomes among Chinese pregnant women. The objectives of study are: 1. To evaluate the efficacy of the proposed intervention in terms of the changes of process outcome variables including trait mindfulness and equanimity at T1 & T2; 2. To evaluate the efficacy of the intervention in terms of the changes of primary outcomes variable including general and pregnant related stress at T1 & T2; 3. To evaluate the efficacy of the intervention in terms of the changes of secondary outcome variables including depression, anxiety, stress coping, satisfaction with life and self-compassion at T1 & T2; 4. To examine the trajectory of general and pregnant related stresses in relation to obstetric and neonatal outcomes after participants have giving birth; 5. To evaluate the effect of process outcome variables on mediating primarily outcome variables.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Pregnancy at 2nd trimester (between 12th to 28th week gestation);
2. Chinese adults (age 18 or above) able to communicate in Chinese;
3. Being able to give informed consent;
4. Being willing and able to attend at least 7 sessions of the intervention/control program.

Inclusion criteria

1. Pregnancy at 2nd trimester (between 12th to 28th week gestation);
2. Chinese adults (age 18 or above) able to communicate in Chinese;
3. Being able to give informed consent;
4. Being willing and able to attend at least 7 sessions of the intervention/control program.

排除标准：

1. Not able to understand Chinese (the intervention will be delivered in Chinese);
2. Undertaking any psychological treatments/meditation practices during pregnancy;
3. High-risk pregnancy status determined by obstetrician report (e.g., preterm labor, placental abnormality, multiple gestation, required bed rest, or morbid obesity);
4. Current psychiatric and mental disorders that necessitated priority attention (e.g., schizoaffective disorder, bipolar disorder, or current psychosis; organic mental disorder or pervasive developmental delay; current eating disorder; current substance abuse or dependence; Post-traumatic stress disorders; imminent suicide or homicide risk.
5. History of neurological problems such as epilepsy and seizures.

Exclusion criteria：

1. Not able to understand Chinese (the intervention will be delivered in Chinese);
2. Undertaking any psychological treatments/meditation practices during pregnancy;
3. High-risk pregnancy status determined by obstetrician report (e.g., preterm labor, placental abnormality, multiple gestation, required bed rest, or morbid obesity);
4. Current psychiatric and mental disorders that necessitated priority attention (e.g., schizoaffective disorder, bipolar disorder, or current psychosis; organic mental disorder or pervasive developmental delay; current eating disorder; current substance abuse or dependence; Post-traumatic stress disorders; imminent suicide or homicide risk.
5. History of neurological problems such as epilepsy and seizures.

研究实施时间：

Study execute time：

从 From 2020-02-01 00:00:00至 To 2021-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-02-01 00:00:00 至 To 2020-05-01 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 38

Group：

Intervention group

Sample size：

干预措施：

Mindfulness-based intervention

干预措施代码：

Intervention：

Mindfulness-based intervention

Intervention code：

组别：

Control group

样本量：

 37

Group：

Control group

Sample size：

干预措施：

Prenatal-psychoeducation

干预措施代码：

Intervention：

Prenatal-psychoeducation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 香港大学 

单位级别：

 大学 

Institution
hospital：

The University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Perceived stress

指标类型：

主要指标

Outcome：

Perceived stress

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

Pregnancy distress

指标类型：

主要指标

Outcome：

Pregnancy distress

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

depression

指标类型：

主要指标

Outcome：

depression

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

anxiety

指标类型：

主要指标

Outcome：

anxiety

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

mindfulness

指标类型：

主要指标

Outcome：

mindfulness

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

maternal attachment

指标类型：

附加指标

Outcome：

maternal attachment

Type：

Additional indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

spirituality

指标类型：

附加指标

Outcome：

spirituality

Type：

Additional indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

affect

指标类型：

附加指标

Outcome：

affect

Type：

Additional indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

self-compassion

指标类型：

附加指标

Outcome：

self-compassion

Type：

Additional indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

self-report

指标中文名：

Equanimity

指标类型：

主要指标

Outcome：

Equanimity

Type：

Primary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

Stress coping

指标类型：

次要指标

Outcome：

Stress coping

Type：

Secondary indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

Social support

指标类型：

附加指标

Outcome：

Social support

Type：

Additional indicator

测量时间点：

测量方法：

self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

Neonatal outcomes

指标类型：

附加指标

Outcome：

Neonatal outcomes

Type：

Additional indicator

测量时间点：

测量方法：

Self-report: Gender, weeks of maturity, birth weight, Apgar score, and birth complication

Measure time point of outcome：

Measure method：

Self-report: Gender, weeks of maturity, birth weight, Apgar score, and birth complication

指标中文名：

Obstetric outcomes

指标类型：

附加指标

Outcome：

Obstetric outcomes

Type：

Additional indicator

测量时间点：

测量方法：

self-report:Maternal/pregnancy complications, length of labor, instrument-assisted birth, and mode of birth.

Measure time point of outcome：

Measure method：

self-report:Maternal/pregnancy complications, length of labor, instrument-assisted birth, and mode of birth.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 25 岁 years
最大 Max age 41 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Randomization was conducted by the study leader, utilizing the block randomization method. Participants were ranked in an order based on their current gestation weeks. Then a block size of four was adopted, with each block having two participants randomly assigned to intervention group and control group respectivel

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

Randomization was conducted by the study leader, utilizing the block randomization method. Participants were ranked in an order based on their current gestation weeks. Then a block size of four was adopted, with each block having two participants randomly assigned to intervention group and control group respectivel

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

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）：

Both the quantitative and qualitative data can be shared upon request. It can also be shared to potential users through email using a password protected file.

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

Both the quantitative and qualitative data can be shared upon request. It can also be shared to potential users through email using a password protected file.

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：

Questionnaires will be collected via online questionnaire website, which is www.WJX.cn. Once the questionnaires are filled up by participants, the website will generate and organize the data into a downloadable document, such as EXCEL file.

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

Questionnaires will be collected via online questionnaire website, which is www.WJX.cn. Once the questionnaires are filled up by participants, the website will generate and organize the data into a downloadable document, such as EXCEL file.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-03 02:06:54