基于 IMB 模型的海南医学生心理健康医防融合干预的模式构建与实证研究

注册号:

Registration number:

ChiCTR2600119465 

最近更新日期:

Date of Last Refreshed on:

2026-02-27 14:55:00 

注册时间:

Date of Registration:

2026-02-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

基于 IMB 模型的海南医学生心理健康医防融合干预的模式构建与实证研究

Public title:

Construction and Empirical Research of the Integrated Intervention Model for Mental Health and Prevention among Medical Students in Hainan Based on the IMB Model

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于 IMB 模型的海南医学生心理健康医防融合干预的模式构建与实证研究

Scientific title:

Construction and Empirical Research of the Integrated Intervention Model for Mental Health and Prevention among Medical Students in Hainan Based on the IMB Model

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:

单侯乾 

研究负责人:

单侯乾 

Applicant:

Shan Houqian 

Study leader:

Shan Houqian 

申请注册联系人电话:

Applicant telephone:

+86 181 9363 1266

研究负责人电话:

Study leader's
telephone:

+86 181 9363 1266

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:

469756305@qq.com

研究负责人电子邮件:

Study leader's E-mail:

469756305@qq.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:

海南省海口市龙华区学院路3号

研究负责人通讯地址:

海南省海口市龙华区学院路3号

Applicant address:

No. 3 Xueyuan Road, Longhua District, Haikou City, Hainan Province

Study leader's address:

No. 3 Xueyuan Road, Longhua District, Haikou City, Hainan 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:

海南医科大学

Applicant's institution:

Hainan Medical University

研究负责人所在单位:

海南医科大学

Affiliation of the Leader:

Hainan 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:

HYLL-2024-192

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:

海南医科大学伦理委员会

Name of the ethic committee:

Ethics Committee of Hainan Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-06-03 00:00:00

伦理委员会联系人:

吴英

Contact Name of the ethic committee:

Wu Ying

伦理委员会联系地址:

海南省海口市龙华区学院路3号

Contact Address of the ethic committee:

No. 3 Xueyuan Road, Longhua District, Haikou City, Hainan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 136 3764 5280

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:

海南医科大学

Primary sponsor:

Hainan Medical University

研究实施负责(组长)单位地址:

海南省海口市龙华区学院路3号

Primary sponsor's address:

No. 3 Xueyuan Road, Longhua District, Haikou City, Hainan 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):

海南

市(区县):

Country:

China

Province:

Hainan

City:

单位(医院):

海南医科大学

具体地址:

海南省海口市龙华区学院路3号

Institution
hospital:

Hainan Medical University

Address:

No. 3 Xueyuan Road, Longhua District, Haikou City, Hainan Province

经费或物资来源:

海南省自然科学基金

Source(s) of funding:

Hainan Provincial Natural Science Foundation

研究疾病:

无  

Target disease:

None

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:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

发掘海南医学生人群心理健康影响因素,缓解并降低海南省医学生人群精神卫生状况  

Objectives of Study:

Explore the factors influencing the mental health of medical students in Hainan, and alleviate and improve the mental health status of medical students in Hainan Province.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.已经产生心理健康问题; 2.有意识障碍、认知功能障碍、精神障碍等影响评估及治疗的患者; 3.其他无法配合健康管理的情况。

Exclusion criteria:

1.Already have mental health problems; 2.Patients with disorders such as consciousness impairment, cognitive dysfunction, and mental disorders that affect assessment and treatment; 3.Other situations where they cannot cooperate with health management.

研究实施时间:

Study execute time:

From 2024-10-11 00:00:00 To 2024-12-19 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-10-11 00:00:00 To 2024-10-15 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

33

Group:

Experimental group

Sample size:

干预措施:

正念减压课程

干预措施代码:

Intervention:

Mindfulness-Based Stress Reduction Course

Intervention code:

组别:

对照组

样本量:

33

Group:

Control 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):

海南 

市(区县):

 

Country:

China

Province:

Hainan

City:

单位(医院):

海南医科大学 

单位级别:

大学 

Institution
hospital:

Hainan Medical University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

压力

指标类型:

主要指标

Outcome:

press

Type:

Primary indicator

测量时间点:

测量方法:

压力知觉量表(PSS)

Measure time point of outcome:

Measure method:

Perceived Stress Scale

指标中文名:

倦怠

指标类型:

主要指标

Outcome:

burnout

Type:

Primary indicator

测量时间点:

测量方法:

大学生学习倦怠调查量表

Measure time point of outcome:

Measure method:

College Student Learning Burnout Inventory

指标中文名:

睡眠

指标类型:

主要指标

Outcome:

sleep

Type:

Primary indicator

测量时间点:

测量方法:

睡眠状况自评量表( SRSS)

Measure time point of outcome:

Measure method:

Self-Rating Scale of Sleep Status

指标中文名:

抑郁

指标类型:

主要指标

Outcome:

Depression

Type:

Primary indicator

测量时间点:

测量方法:

抑郁自评量表(SDS)

Measure time point of outcome:

Measure method:

Self-Rating Depression Scale

指标中文名:

焦虑

指标类型:

主要指标

Outcome:

Anxiety

Type:

Primary indicator

测量时间点:

测量方法:

焦虑自评量表(SAS)

Measure time point of outcome:

Measure method:

Self-Rating Anxiety Scale

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:

结束

/Completed

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):

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

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):

http://www.medresman.org.cn/ 2026年2月-2026年8月

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

http://www.medresman.org.cn/ February 2026 - August 2026

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:

None

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:

 2026-02-27 14:54:54