ChiCTR2600125392 版本V1.0 版本创建时间2026/05/26 15:44:13 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:

ChiCTR2600125392 

最近更新日期:

Date of Last Refreshed on:

2026-05-26 15:44:07 

注册时间:

Date of Registration:

2026-05-26 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

护理硕士专业学位研究生心理韧性的提升:远程数字干预策略研究

Public title:

Enhancing Psychological Resilience among Nursing Postgraduates: A Study on Remote Digital Intervention Strategies

注册题目简写:

English Acronym:

研究课题的正式科学名称:

护理硕士研究生心理韧性的提升:远程数字干预策略研究

Scientific title:

Enhancing Psychological Resilience among Nursing Postgraduates: A Study on Remote Digital Intervention Strategies

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:

朱欣悦 

研究负责人:

游贝贝 

Applicant:

Xinyue Zhu 

Study leader:

Beibei You 

申请注册联系人电话:

Applicant telephone:

+86 151 8660 2417

研究负责人电话:

Study leader's
telephone:

+86 188 7509 8809

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:

2404028018@qq.com

研究负责人电子邮件:

Study leader's E-mail:

cog0812@163.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:

贵州省贵安新区安康大道6号

研究负责人通讯地址:

贵州省贵安新区安康大道6号

Applicant address:

No. 6, Ankang Avenue, Gui'an New Area, Guizhou Province

Study leader's address:

No. 6, Ankang Avenue, Gui'an New Area, Guizhou 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:

贵州医科大学

Applicant's institution:

Guizhou Medical University

研究负责人所在单位:

贵州医科大学

Affiliation of the Leader:

Guizhou Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2026伦审第41号

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:

贵州医科大学人体试验伦理委员会

Name of the ethic committee:

The Ethics Committee of Guizhou Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-04 00:00:00

伦理委员会联系人:

汤磊

Contact Name of the ethic committee:

Lei Tang

伦理委员会联系地址:

贵州省贵安新区安康大道6号

Contact Address of the ethic committee:

No. 6, Ankang Avenue, Gui'an New Area, Guizhou Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 851 8841 6075

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:

贵州医科大学

Primary sponsor:

Guizhou Medical University

研究实施负责(组长)单位地址:

贵州省贵安新区安康大道6号

Primary sponsor's address:

No. 6, Ankang Avenue, Gui'an New Area, Guizhou Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

贵州省

市(区县):

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州医科大学

具体地址:

贵州省贵安新区安康大道6号

Institution
hospital:

Guizhou Medical University

Address:

No. 6, Ankang Avenue, Gui'an New Area, Guizhou Province

经费或物资来源:

贵州省研究生教育教学研究项目,2024YJSJGXM062

Source(s) of funding:

Guizhou Provincial Postgraduate Education and Teaching Research Project, 2024YJSJGXM062

研究疾病:

心理韧性不足  

Target disease:

Poor psychological resilience

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:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

本项目旨在通过远程数字干预策略提升护理硕士专业学位研究生的心理韧性,帮助他们更好地应对学术压力、临床实践挑战和职业发展的多重压力,增强情绪调节能力,进而提升其整体表现。 具体目标包括:1.提升心理韧性水平。减少护理硕士专业学位研究生因学术和临床实习压力引发的焦虑、抑郁等负面情绪,帮助护理研究生保持积极的心理状态。2.开发专用数字化心理干预工具。结合护理专业特点,设计并验证专为护理研究生心理韧性提升而开发的远程数字干预工具。3.构建标准化干预体系。为护理专业教育与心理健康管理提供一套标准化的、可复制推广的干预体系。  

Objectives of Study:

This project aims to enhance the psychological resilience of master's degree students in nursing through remote digital intervention strategies, helping them better cope with academic pressure, clinical practice challenges, and multiple pressures related to career development, and improving their emotional regulation abilities, thereby enhancing their overall performance. Specific goals include: 1. Improving the level of psychological resilience. Reducing negative emotions such as anxiety and depression among master's degree students in nursing caused by academic and clinical practice pressures, and helping nursing students maintain a positive psychological state. 2. Developing dedicated digital psychological intervention tools. Based on the characteristics of the nursing profession, designing and validating remote digital intervention tools specifically developed to enhance the psychological resilience of nursing students. 3. Establishing a standardized intervention system. Providing a set of standardized, replicable and scalable intervention systems for nursing education and mental health management.

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.全日制在读护理硕士专业学位研究生。 2.临床实习时间>8个月。 3.意识清楚,认知功能正常,可使用或在指导下使用智能手机及常见应用程序(如微信、健康管理类APP),拥有iOS操作系统或Android操作系统手机。 4.能保证完成 12 周干预及前后测评估(如时间充足、网络稳定)。 5.签署知情同意书,自愿参与本研究。

Inclusion criteria

1. Full-time master's degree student majoring in nursing. 2. Clinical internship duration > 8 months. 3. Clear consciousness, normal cognitive function, able to use or use with guidance smartphones and common applications (such as WeChat, health management apps), with iOS operating system or Android operating system mobile phones. 4. Able to complete 12 weeks of intervention and pre-test/post-test assessment (if there is sufficient time and stable network). 5. Sign the informed consent form and voluntarily participate in this study.

排除标准:

1.过去1个月内参与过或正在接受其他系统性心理干预或临床试验者。 2.存在严重的精神心理障碍或物质滥用情况,经评估可能影响访谈有效性,或因其他原因无法配合调查者。 3.中途退出研究或退学。

Exclusion criteria:

1. Those who have participated in or are currently undergoing other systematic psychological interventions or clinical trials within the past 1 month. 2. Those with severe mental or psychological disorders or substance abuse, whose condition has been assessed as potentially affecting the validity of the interview, or who are unable to cooperate with the investigators for other reasons. 3. Those who have withdrawn from the study or dropped out of school.

研究实施时间:

Study execute time:

From 2026-03-04 00:00:00 To 2027-09-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-05-27 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

35

Group:

Intervention group

Sample size:

干预措施:

接受为期12周的远程数字心理韧性干预,每周进行定期训练和反馈

干预措施代码:

Intervention:

12-week remote digital psychological resilience intervention (weekly regular training and feedback)

Intervention code:

组别:

对照组

样本量:

35

Group:

Control group

Sample size:

干预措施:

常规心理支持(不接受主动干预)

干预措施代码:

Intervention:

Routine mental health support (no active intervention)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

贵州省 

市(区县):

 

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州医科大学 

单位级别:

大学 

Institution
hospital:

Guizhou Medical University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

心理韧性

指标类型:

主要指标

Outcome:

Resilience

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪调节自我效能感

指标类型:

次要指标

Outcome:

Emotional Self-Efficacy

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学业压力

指标类型:

次要指标

Outcome:

Academic Pressure

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床压力

指标类型:

主要指标

Outcome:

Clinical Pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会支持

指标类型:

主要指标

Outcome:

Social Support

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:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 years
最大 Max age 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):

由研究人员采用随机数字表法产生随机序列,按 1:1 比例将研究对象分配至干预组与对照组。

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

A random number sequence was generated by the researcher using a random number table method, and participants were allocated to the intervention group and control group in a 1:1 ratio.

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:

Blinding:

None

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

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):

None

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-05-26 15:44:07