基于沉浸式虚拟仿真系统的死亡反省对护生优逝认知及死亡态度的影响:一项随机对照试验

注册号:

Registration number:

ChiCTR2500110985 

最近更新日期:

Date of Last Refreshed on:

2025-10-23 15:09:31 

注册时间:

Date of Registration:

2025-10-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于沉浸式虚拟仿真系统的死亡反省对护生优逝认知及死亡态度的影响:一项随机对照试验

Public title:

The Impact of Death Reflection Based on an Immersive Virtual Simulation System on Nursing Students' perception of a Good Death and Attitudes Toward Death: A randomized controlled trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于沉浸式虚拟仿真系统的死亡反省对护生优逝认知及死亡态度的影响

Scientific title:

The Impact of Death Reflection Based on an Immersive Virtual Simulation System on Nursing Students' perception of a Good Death and Attitudes Toward Death

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:

景雪冰 

研究负责人:

景雪冰 

Applicant:

Jing Xuebing 

Study leader:

Jing Xuebing 

申请注册联系人电话:

Applicant telephone:

+86 186 7818 5821

研究负责人电话:

Study leader's
telephone:

+86 186 7818 5821

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:

jingxuebing@163.com

研究负责人电子邮件:

Study leader's E-mail:

jingxuebing@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:

淄博市张店区上海路10号淄博市中心医院

研究负责人通讯地址:

淄博市张店区上海路10号淄博市中心医院

Applicant address:

No. 10 Shanghai Road, Zhangdian District, Zibo City, Shandong Province

Study leader's address:

No. 10 Shanghai Road, Zhangdian District, Zibo City, Shandong Province

申请注册联系人邮政编码:

Applicant postcode:

255000

研究负责人邮政编码:

Study leader's postcode:

255000

申请人所在单位:

淄博市中心医院

Applicant's institution:

Zibo Central Hospital

研究负责人所在单位:

淄博市中心医院

Affiliation of the Leader:

Zibo Central Hospital

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:

2025研第228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:

淄博市中心医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Zibo Central Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025-09-01 00:00:00

伦理委员会联系人:

司志鹏

Contact Name of the ethic committee:

Si Zhipeng

伦理委员会联系地址:

山东省淄博市张店区上海路10号

Contact Address of the ethic committee:

No. 10 Shanghai Road, Zhangdian District, Zibo City, Shandong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 185 6029 3690

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:

淄博市中心医院

Primary sponsor:

Zibo Central Hospital

研究实施负责(组长)单位地址:

山东省淄博市张店区上海路10号

Primary sponsor's address:

No. 5678 Renmin West Road, Zhoucun District, Zibo City, Shandong 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):

山东省

市(区县):

淄博市

Country:

China

Province:

Shandong

City:

Zibo

单位(医院):

淄博市中心医院

具体地址:

山东省淄博市张店区上海路10号

Institution
hospital:

Zibo Central Hospital

Address:

No. 10 Shanghai Road, Zhangdian District, Zibo City, Shandong Province

经费或物资来源:

Source(s) of funding:

None

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:

随机平行对照 

Study design:

Parallel 

研究目的:

研究旨在评估基于沉浸式虚拟仿真系统的死亡反省对护生优逝认知及死亡态度的影响及作用,以提高护生的优逝认知,改善死亡态度。  

Objectives of Study:

The study aims to evaluate the impact and role of death reflection based on an immersive virtual simulation system on nursing students' cognition of a good death and their attitudes toward death, so as to enhance their cognition of a good death and improve their attitudes toward death.

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.因请假或其他不可抗力因素要求中途退出研究者;2.观察指标等信息填写不完整者。3.有视力障碍,无法观看VR视频;4.观看VR视频时出现恶心、头晕;5.有癫痫症状。

Exclusion criteria:

1.Those who request to withdraw from the study midway due to leave, force majeure, or other reasons; 2.Those with incomplete filling of information such as observation indicators; 3.Those with visual impairment (unable to watch VR videos), 4. Those who experience nausea or dizziness while watching VR videos; 5.Those with epileptic symptoms.

研究实施时间:

Study execute time:

From 2025-11-01 00:00:00 To 2026-03-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-11-01 00:00:00 To 2025-12-31 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

采用常规的死亡教育方法,教师ppt讲座加互动,时长90分钟

干预措施代码:

Intervention:

Conventional death education methods are adopted, which include teachers' PPT lectures combined with interactions, with a duration of 90 minutes.

Intervention code:

组别:

试验组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

基于沉浸式虚拟仿真系统师生互动,教师引导学生进行死亡反省,总时长90分钟。

干预措施代码:

Intervention:

Through teacher-student interaction based on an immersive virtual simulation system, teachers guide students to conduct death reflection, with a total duration of 90 minutes.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

山东省 

市(区县):

淄博市 

Country:

China

Province:

Shandong

City:

Zibo

单位(医院):

淄博市中心医院 

单位级别:

三甲 

Institution
hospital:

Zibo Central Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

优逝认知

指标类型:

主要指标

Outcome:

Perception of good death

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡态度

指标类型:

主要指标

Outcome:

Attitudes toward death

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学习满意度

指标类型:

次要指标

Outcome:

Learning satisfaction

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学习自信心

指标类型:

次要指标

Outcome:

Learning self-confidence

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

共情能力

指标类型:

次要指标

Outcome:

Empathy

Type:

Secondary 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):

由一名熟悉并能熟练运用医学统计知识且不参与本研究其他任务的研究生用Excel产生随机序列。

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

A graduate student who is familiar with and proficient in medical statistics and does not participate in other tasks in this study produces random sequences using Excel.

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:

在开展教学干预的过程中难以对研究者和研究对象设盲,因此本研究仅对数据分析员设盲。

Blinding:

In the process of carrying out teaching intervention, it is difficult to set blind to researchers and research objects, so this study only set blind to data analysts.

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:

电子采集和管理

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

Electronic Data Capture

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:

 2025-10-23 15:09:18