ChiCTR2500115481 版本V1.1 版本创建时间2025/12/28 13:09:10 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：

ChiCTR2500115481 

最近更新日期：

Date of Last Refreshed on：

2025-12-26 14:34:06 

注册时间：

Date of Registration：

2025-12-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于ADDIE教学模型的新入职护士中医辨证能力培训方案的构建及应用研究

Public title：

Development and Application of a Training Program on Traditional Chinese Medicine Syndrome Differentiation for Newly Hired Nurses Based on the ADDIE Model

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于ADDIE教学模型的新入职护士中医辨证能力培训方案的构建及应用研究

Scientific title：

Development and Application of a Training Program on Traditional Chinese Medicine Syndrome Differentiation for Newly Hired Nurses Based on the ADDIE 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：

张瑜 

研究负责人：

张瑜 

Applicant：

Zhang Yu 

Study leader：

Zhang Yu 

申请注册联系人电话：

Applicant telephone：

+86 150 3512 7517

研究负责人电话：

Study leader's telephone：

+86 150 3512 7517

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：

1026612782@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1026612782@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：

中国山西省太原市迎泽区并州西街46号

研究负责人通讯地址：

中国山西省太原市迎泽区并州西街46号

Applicant address：

46 West Bingzhou Street, Yingze District, Taiyuan City, Shanxi Province, China

Study leader's address：

46 West Bingzhou Street, Yingze District, Taiyuan City, Shanxi Province, 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：

山西省中医药研究院(山西省中医院)

Applicant's institution：

Shanxi Province Academy of Traditional Chinese Medicine (Shanxi Province Hospital of Traditional Chinese Medicine)

研究负责人所在单位：

山西省中医药研究院(山西省中医院)

Affiliation of the Leader：

Shanxi Province Academy of Traditional Chinese Medicine (Shanxi Province Hospital of Traditional Chinese Medicine)

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：

2025KY-08082

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：

山西省中医药研究院医学伦理委员会

Name of the ethic committee：

Ethics Review Committee, Shanxi Institute of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-09 00:00:00

伦理委员会联系人：

卫雅婧

Contact Name of the ethic committee：

Wei Yajing

伦理委员会联系地址：

中国山西省太原市迎泽区并州西街46号

Contact Address of the ethic committee：

46 West Bingzhou Street, Yingze District, Taiyuan City, Shanxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 182 3405 6248

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：

山西省中医药研究院(山西省中医院)

Primary sponsor：

Shanxi Province Academy of Traditional Chinese Medicine (Shanxi Province Hospital of Traditional Chinese Medicine)

研究实施负责（组长）单位地址：

中国山西省太原市迎泽区并州西街46号

Primary sponsor's address：

46 West Bingzhou Street, Yingze District, Taiyuan City, Shanxi Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山西

市(区县)：

太原

Country：

China

Province：

Shanxi

City：

Taiyuan

单位(医院)：

山西省中医药研究院(山西省中医院)

具体地址：

中国山西省太原市迎泽区并州西街46号

Institution
hospital：

Shanxi Provincial Institute of Traditional Chinese Medicine

Address：

46 West Bingzhou Street, Yingze District, Taiyuan City, Shanxi Province, China

经费或物资来源：

山西省卫生健康委员会中医药科技与产业处，项目编号为2025ZYYB001

Source(s) of funding：

Department of Traditional Chinese Medicine Science and Technology & Industry, Health Commission of Shanxi Province

Target disease：

Training in Traditional Chinese Medicine Pattern Differentiation

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：

1.基于ADDIE模型构建新入职护士中医辨证能力培训方案； 2.对培训方案进行教学实践初步应用和评价，为中医院新护士辨证能力培训提供参考依据。  

Objectives of Study：

1. A training program for the traditional Chinese medicine syndrome differentiation ability of newly recruited nurses was developed based on the ADDIE model. 2. The training program was initially applied and evaluated in teaching practice, providing a reference basis for the syndrome differentiation ability training of new nurses in traditional Chinese medicine hospitals.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

第一部分：基于ADDIE模型的新入职护士中医辨证能力培训方案的构建 1.现况调查 （1）取得中华人民共和国卫生健康委员会颁发的护士执业资格证书或未取得证但执业考试成绩合格者； （2）在医院从事临床护理工作＜＝3年； （3）自愿参与本研究至研究结束。 2.质性访谈 （1）语言表达清晰，知情同意并参与本研究者； （2）取得中华人民共和国卫生健康委员会颁发的护士执业资格证书或未取得证书但执业考试成绩合格者； （3）在医院从事中医护理工作＜＝3年； （4）在现况调查阶段问卷得分较低和较高者。 第二部分：基于ADDIE模型中医辨证能力培训方案的应用研究 1.类实验研究 （1）具有护士执业证书并注册； （2）规培时间＞＝1年； （3）既往无中医护理临床工作经验； （4）自愿参与本研究，并签署知情同意书。

Inclusion criteria

Part I: A training program for the traditional Chinese medicine syndrome differentiation ability of newly recruited nurses was developed based on the ADDIE model. 1. Survey of Current Status (1) Hold a Nurse Practicing Certificate issued by the National Health Commission of the People's Republic of China or have passed the National Nurse Licensing Examination (for those awaiting certification); (2) Have been engaged in clinical nursing practice in a hospital for three years or less; (3) Voluntarily agree to participate and commit to the study until its completion. 2. Qualitative Interviews (1) Possess clear verbal expression skills, provide informed consent, and agree to participate; (2) Hold a Nurse Practicing Certificate issued by the National Health Commission of the People's Republic of China or have passed the National Nurse Licensing Examination (for those awaiting certification); (3) Have been engaged in Traditional Chinese Medicine nursing practice in a hospital for three years or less; (4) Include participants who scored both lower and higher on the survey questionnaire administered in the current status assessment phase. Part II: The training program was initially applied and evaluated in teaching practice, providing a reference basis for the syndrome differentiation ability training of new nurses in traditional Chinese medicine hospitals. 1.Quasi-Experimental Study (1) A valid registered nurse practicing license; (2)No less than one year of standardized training; (3) No prior work experience in clinical traditional chinese medicine nursing; (4) Participants who volunteered for the study and provided informed consent.

排除标准：

第一部分：基于ADDIE模型的新入职护士中医辨证能力培训方案的构建 1.现况调查 （1）处于孕期、产假、病假者； （2）在其他中医医疗机构从事临床护理工作＞＝3年； （3）进修护士或非本院护士； （4）拒绝参与本研究者。 2.质性访谈 （1）处于孕期、休产假、病假者； （2）在其他中医医疗机构从事临床护理工作＞＝3年； （3）进修护士或非本院护士； （4）问卷经评估为无效作答（如胡乱填写、答案呈现规律性）者； （5）存在语言或听力障碍。 第二部分：基于ADDIE模型中医辨证能力培训方案的应用研究 1.类实验研究 （1）干预过程中因任何原因造成失访或缺席培训活动数次者。

Exclusion criteria：

Part I: A training program for the traditional Chinese medicine syndrome differentiation ability of newly recruited nurses was developed based on the ADDIE model. 1. Survey of Current Status (1) Participants who were pregnant, on maternity leave, or sick leave; (2) Participants who had been engaged in clinical nursing practice in other Traditional Chinese Medicine medical institutions for three years or more; (3) Nurses from other institutions or those not formally employed by the host hospital; (4) Participants who declined to participate in the study. 2. Qualitative Interviews (1) Participants who were pregnant, on maternity leave, or sick leave; (2) Participants who had been engaged in clinical nursing practice in other Traditional Chinese Medicine medical institutions for three years or more; (3) Nurses from other institutions or those not formally employed by the host hospital; (4) Participants whose questionnaires were deemed invalid due to responses that were either random or demonstrated a systematic pattern; (5) Participants with language or hearing impairments. Part II: The training program was initially applied and evaluated in teaching practice, providing a reference basis for the syndrome differentiation ability training of new nurses in traditional Chinese medicine hospitals. 1.Quasi-Experimental Study Participants who were lost to follow-up or absent from any training session for any reason during the intervention period.

研究实施时间：

Study execute time：

从 From 2025-12-29 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-29 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

第一部分 现况调查

样本量：

126

Group：

Part I Survey of Current Status

Sample size：

干预措施：

调查省内部分三甲中医院新入职护士中医护理培训现状

干预措施代码：

Intervention：

An examination of the current Traditional Chinese Medicine nursing training provisions for new nursing staff was performed in several tertiary-level Traditional Chinese Medicine hospitals in the province.

Intervention code：

组别：

第一部分 质性访谈

样本量：

10

Group：

Part I Qualitative Interviews

Sample size：

干预措施：

基于半结构访谈法了解新入职护士对中医护理培训体验与需求

干预措施代码：

Intervention：

An exploration of the training experiences and needs of newly hired nurses in Traditional Chinese Medicine nursing was conducted using semi-structured interviews.

Intervention code：

组别：

第二部分 类实验研究：试验组

样本量：

40

Group：

Part II Quasi-Experimental Study: Experimental Group

Sample size：

干预措施：

按照基于ADDIE教学模型的中医辨证能力培训方案进行培训

干预措施代码：

Intervention：

The training was conducted in accordance with the training program for Traditional Chinese Medicine syndrome differentiation ability based on the ADDIE teaching model

Intervention code：

组别：

第二部分 类实验研究：对照组

样本量：

40

Group：

Part II Quasi-Experimental Study: Control group

Sample size：

干预措施：

按照“单病中医护理”的传统课程进行培训

干预措施代码：

Intervention：

The training was based on a traditional curriculum structured around "Single-Disease Traditional Chinese Medicine Nursing".

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 太原 

Country：

China 

Province：

Shanxi 

City：

Taiyuan 

单位(医院)：

山西省中医药研究院(山西省中医院) 

单位级别：

三甲 

Institution
hospital：

Shanxi Province Academy of Traditional Chinese Medicine (Shanxi Province Hospital of Traditional Chinese Medicine)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

第一部分 现况调查：中医护理知信行水平调查问卷

指标类型：

主要指标

Outcome：

Nurse Knowledge, Attitude, and Practice Questionnaire on traditional chinese medicine Nursing

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第一部分 现况调查：一般资料调查表

指标类型：

次要指标

Outcome：

General Information Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第二部分 类实验研究：理论以及操作考核成绩

指标类型：

主要指标

Outcome：

Theoretical and clinical assessment scores

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第二部分 类实验研究：教学质量评价

指标类型：

次要指标

Outcome：

Teaching quality evaluation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第二部分 类实验研究：中医护理知信行水平调查问卷

指标类型：

次要指标

Outcome：

Nurse Knowledge, Attitude, and Practice Questionnaire on traditional chinese medicine Nursing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第二部分 类实验研究：患者中医护理满意度

指标类型：

次要指标

Outcome：

Patients' Satisfaction with Traditional Chinese Medicine Nursing

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：

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 35 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）：

本研究采用非随机对照试验设计。计划将2024年1月至2024年12月于山西省中医药研究院新入职且符合纳入标准的所有护士作为研究对象。将使用SPSS 26.0软件生成一份1-80的随机数字表。随机数字及对应的组别分配信息将被装入按顺序编号、不透光的密封信封中。研究者将依据受试者的入组顺序，开启对应的信封，从而将其分配至干预组或对照组。随机数字表及分组信息将由专门的随机化人员严格保管。

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

This study employs a non-randomized controlled trial design. All newly hired nurses who meet the inclusion criteria and commence employment at the Shanxi Provincial Academy of Traditional Chinese Medicine between January and December 2024 will be enrolled as participants. A random number table ranging from 1 to 80 will be generated using SPSS 26.0 software. The random numbers and corresponding group allocation information will be sealed in sequentially numbered, opaque envelopes. Based on the order of enrollment, the researcher will open the corresponding envelope to assign each participant to either the intervention group or the control group. The random number table and allocation details will be strictly maintained and kept confidential by dedicated randomization personnel.

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：

由于本研究的干预措施为培训方案，受试者及研究实施团队均知晓分组安排，故无法对此双方实施盲法。为减少测量偏倚，本研究对结局评估人员设置了盲法。具体而言，所有参与理论考试评分及客观结构化临床考核评分的考官，均不了解受试者所属组别。此外，负责数据统计的研究员在完成分析前亦对分组信息保持盲态。

Blinding：

Given the interventional nature of the training program, it will not be feasible to blind the participants or the research team. To mitigate measurement bias, outcome assessors and the data analyst will be blinded. All theoretical and OSCE examiners will be unaware of participant group assignments, and the statistician will perform analyses prior to unblinding.

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：

本研究采用纸质与电子相结合的方式进行数据采集。问卷类数据通过“问卷星”在线平台收集，数据自动导出为电子格式；考核类数据则由考官在纸质标准化评分表上记录。所有纸质数据后续由双人独立录入电子数据库，并与问卷数据共同整合，形成最终的分析数据集。

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

Our study employed a hybrid paper-and-electronic data collection approach. Questionnaire-based data were collected via the "Wenjuanxing" online platform, which automatically exported the data in electronic format. In contrast, assessment data were recorded by examiners on paper-based standardized scoring sheets. All paper-based data were subsequently entered electronically by two independent individuals to create a digital database. Finally, data from both sources were merged to form the final analysis dataset.

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：

  2025-12-26 14:34:02