ChiCTR2500115671 版本V1.0 版本创建时间2025/12/30 08:41:28 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：

ChiCTR2500115671 

最近更新日期：

Date of Last Refreshed on：

2025-12-30 08:40:46 

注册时间：

Date of Registration：

2025-12-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

《“三问人生”生死教育活动对护士学生生命意义和死亡素养影响的随机对照试验》

Public title：

A Randomized Controlled Trial on the impact of the "Three Questions of Life " Death Education Program on the Sense of Meaning and Death Litreracy of Nursing Students

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“三问人生”生死教育活动对护士学生生命意义和死亡素养的影响

Scientific title：

The impact of the "Three Questions of Life " Death Education Activities on the Sense of Meaning and Death Litreracy of Nursing Students

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：

陈之冰 

研究负责人：

陈之冰 

Applicant：

Chen Zhibing 

Study leader：

Chen Zhibing 

申请注册联系人电话：

Applicant telephone：

+86 132 7785 0862

研究负责人电话：

Study leader's telephone：

+86 199 8328 9961

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：

mn2024016@stud.kwnc.edu.mo

研究负责人电子邮件：

Study leader's E-mail：

mn2024016@stud.kwnc.edu.mo

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：

澳门离岛路氹填海区离岛医院大马路447号

研究负责人通讯地址：

澳门离岛路氹填海区离岛医院大马路447号

Applicant address：

No. 447, Avenida da Comercio, Taipa Reclamation Area, Taipa Island Road, Macau

Study leader's address：

No. 447, Avenida da Comercio, Taipa Reclamation Area, Taipa Island Road, Macau

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：

澳门镜湖护理学院

Applicant's institution：

Kiang Wu Nursing College of Macau

研究负责人所在单位：

澳门镜湖护理学院

Affiliation of the Leader：

Kiang Wu Nursing College of Macau

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

REC-2025.08

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：

澳门镜湖护理学院

Name of the ethic committee：

Kiang Wu Nursing College of Macau

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-16 00:00:00

伦理委员会联系人：

陈芷芍

Contact Name of the ethic committee：

Chen Zhishao

伦理委员会联系地址：

澳门离岛路氹填海区离岛医院大马路447号

Contact Address of the ethic committee：

No. 447, Avenida da Comercio, Taipa Reclamation Area, Taipa Island Road, Macau

伦理委员会联系人电话：

Contact phone of the ethic committee：

+853 8295 6235

伦理委员会联系人邮箱：

Contact email of the ethic committee：

admin@kwnc.edu.mo

研究实施负责（组长）单位：

澳门镜湖护理学院

Primary sponsor：

Kiang Wu Nursing College of Macau

研究实施负责（组长）单位地址：

澳门离岛路氹填海区离岛医院大马路447号

Primary sponsor's address：

No. 447, Avenida da Comercio, Taipa Reclamation Area, Taipa Island Road, Macau

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

澳门特别行政区

市(区县)：

Country：

China

Province：

Macao Special Administrative Region

City：

单位(医院)：

澳门镜湖护理学院

具体地址：

澳门离岛路氹填海区离岛医院大马路447号

Institution
hospital：

Kiang Wu Nursing College of Macau

Address：

No. 447, Avenida da Comercio, Taipa Reclamation Area, Taipa Island Road, Macau

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

None

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：

1.验证生死教育活动对实验组学生的生命意义的有效性； 2.验证生死教育活动对实验组学生的死亡素养的有效性。  

Objectives of Study：

1. Verify the effectiveness of the life education activities in enhancing the students' understanding of life in the experimental group; 2. Verify the effectiveness of the life education activities in improving the students' death literacy in the experimental group.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.2025-2026学年入学的澳门镜湖护理学院护理学专业大一新生，未接受系统的生死教育课程。 2.年龄为18岁及以上，具备完全民事行为能力。 3.自愿参与研究，签署知情同意书，且能够全程配合研究。 4.身体健康，完成澳门镜湖护理学院入学要求的体格检查，无语言或认知障碍，能准确理解并填写中文版问卷。

Inclusion criteria

1.Freshmen of the Nursing program at Macau Kiang Wu College of Nursing who are enrolling in the 2025-2026 academic year have not received systematic life and death education courses. 2. Be 18 years old or above and have full capacity for civil conduct. 3. Voluntarily participate in the research, sign the informed consent form, and be able to cooperate with the research throughout the process. 4. Good health, having completed the physical examination required for admission to Macau Kiang Wu College of Nursing, without language or cognitive impairments, and capable of accurately understanding and filling out the Chinese version of the questionnaire.

排除标准：

1.曾经参与过系统的生死教育课程或工作坊的学生。 2.诊断患有心理障碍或精神疾病的学生，或正在接受心理治疗或药物治疗。 3.中途因个人原因无法完成全部干预活动或前后测而退出者。

Exclusion criteria：

1. Students who have participated in systematic life-and-death education courses or workshops. 2. Students diagnosed with psychological disorders or mental illnesses, or those undergoing psychological therapy or medication treatment. 3. Students who withdrew halfway due to personal reasons and were unable to complete all intervention activities or post-test.

研究实施时间：

Study execute time：

从 From 2025-10-16 00:00:00至 To 2026-10-16 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-30 00:00:00 至 To 2026-01-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

42

Group：

Experimental Group

Sample size：

干预措施：

参与为期两周，每周两次共四次的生死教育活动

干预措施代码：

Intervention：

Participate in a two-week life and death education activity, twice a week for a total of four times

Intervention code：

组别：

对照组

样本量：

42

Group：

Control group

Sample size：

干预措施：

不接受生死教育活動

干预措施代码：

Intervention：

Do not accept life and death education activities

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 澳门特别行政区 

市(区县)：

  

Country：

China 

Province：

Macao Special Administrative Region 

City：

 

单位(医院)：

澳门镜湖护理学院 

单位级别：

大学 

Institution
hospital：

Kiang Wu Nursing College of Macau

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

生命意义感问卷

指标类型：

主要指标

Outcome：

Questionnaire on the Sense of Meaning in Life

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

死亡素养指数

指标类型：

主要指标

Outcome：

Death Literacy Index

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：

无

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 18 岁 years
最大 Max age 岁 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）：

参与者基于招募顺序拿到编号为1-84的信封，由不参与干预研究的第三者利用Python生成随机序列，并打乱参与者列表，前42人纳入实验组，后42人纳入对照组，后对两组分别再次进行随机打乱，每组分成三个子组，每个子组各14人，实验组编码子组分别编码为A、B、C，对照组子组分别编码为D、E、F

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

The participants received envelopes numbered 1 to 84 based on the recruitment order. A third party, who was not involved in the intervention study, used Python to generate a random sequence and shuffle the list of participants. The first 42 participants were included in the experimental group, and the last 42 participants were included in the control group. Then, each group was randomly shuffled again, and each group was divided into three subgroups, with 14 people in each subgroup. The subgroups of the experimental group were coded as A, B, and C, while the subgroups of the control group were coded as D, E, and F.

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：

本研究采用的是测量者盲法和研究对象盲法，所有结局指标的前测与后测均通过独立第三方测量，此外研究对象不清楚自己是否被分到实验组或对照组

Blinding：

The study adopted the measurement-blinding method and the subject blinding method. All the pretests and posttests of the outcome indicators were measured independently by another one. In addition, the subjects were not clear whether they were assigned to the experimental group or the control group

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

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）：

无

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：

实验计划于2025年12月左右实施，将于生死教育活动开始前与干预活动结束当天，指导实验组和对照组填写《生命意义感量表（MLQ-C）》和《死亡素养指数（DLI）》，耗时约30分钟，后测结束后指导实验组填写《课程回馈表》。在实验期间，研究者将每日通过微信提醒实验组与对照组填写《活动记录表》，并于干预结束后收集两组学生填写的记录表。 所有回收数据，以及在活动过程中的个人表达，均会保密。所有问卷和记录表采用匿名化处理，参与者以唯一编号标识。数据通过电子问卷平台收集，导出为Excel格式，仅供研究者本人访问，并且仅用于学术用途。记录入完成后，由两名研究者共同核对，确保资料准确性。研究结束后，所有资料将在两年内销毁。

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

The experiment is scheduled to be carried out around December 2025. It will be conducted before the start of the life education activities and on the day when the intervention activities end. The experiment group and the control group will be instructed to fill out the "Life Meaning Scale (MLQ-C)" and the "Death Literacy Index (DLI)" within approximately 30 minutes. After the post-test, the experiment group will be guided to fill out the "Course Feedback Form". During the experiment period, the researchers will remind the experiment group and the control group to fill out the "Activity Record Form" via WeChat every day, and after the intervention is completed, the record forms filled out by both groups of students will be collected. All the collected data, as well as the personal expressions during the activity, will be kept confidential. All questionnaires and record forms are anonymized, and participants are identified by a unique number. The data is collected through an electronic questionnaire platform and exported in Excel format. It is accessible only to the researcher himself/herself and is used solely for academic purposes. After the records are completed, they are double-checked by two researchers to ensure the accuracy of the data. After the research is completed, all the data will be destroyed within two years.

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：

  2025-12-30 08:40:46