ChiCTR2400094158 版本V1.0 版本创建时间2024/12/17 17:16:32 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：

ChiCTR2400094158 

最近更新日期：

Date of Last Refreshed on：

2024-12-17 17:16:20 

注册时间：

Date of Registration：

2024-12-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于建构主义理论的达芬奇手术护理配合能力虚拟仿 真培训方案的构建与应用

Public title：

To construct and application of Da Vinci surgical nursing cooperation ability virtual simulation training program based on constructivism theory

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于建构主义理论的达芬奇手术护理配合能力虚拟仿真培训方案的构建与应用研究

Scientific title：

Construction and application of Da Vinci surgical nursing cooperation ability virtual simulation training program based on constructivism theory

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：

王钰莹 

研究负责人：

林珂 

Applicant：

Yuying Wang  

Study leader：

Ke Lin 

申请注册联系人电话：

Applicant telephone：

+86 133 3032 1090

研究负责人电话：

Study leader's telephone：

+86 133 3032 1090

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：

623010608@qq.com

研究负责人电子邮件：

Study leader's E-mail：

623010608@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：

云南省昆明市五华区滇缅大道昆明医科大学第二附属医院

研究负责人通讯地址：

云南省昆明市五华区滇缅大道昆明医科大学第二附属医院

Applicant address：

The Second Affiliated Hospital of Kunming Medical University, Yunnan-Burma Avenue, Wuhua District, Kunming City, Yunnan Province, China

Study leader's address：

The Second Affiliated Hospital of Kunming Medical University, Yunnan-Burma Avenue, Wuhua District, Kunming City, Yunnan Province, China

申请注册联系人邮政编码：

Applicant postcode：

650500

研究负责人邮政编码：

Study leader's postcode：

650500

申请人所在单位：

昆明医科大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Kunming Medical University

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：

审-PJ-科-2024-117

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：

昆明医科大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-05-13 00:00:00

伦理委员会联系人：

丁明霞

Contact Name of the ethic committee：

Ding Mingxia

伦理委员会联系地址：

云南省昆明市五华区滇缅大道昆明医科大学第二附属医院医学伦理委员会

Contact Address of the ethic committee：

Medical Ethics Committee, The Second Affiliated Hospital of Kunming Medical University, Yunnan-Burma Avenue, Wuhua District, Kunming City, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 138 8828 9286

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：

昆明医科大学第二附属医科麻醉手术科

Primary sponsor：

Department of Anesthesiology and Surgery, the Second Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

云南省昆明市五华区滇缅大道昆明医科大学第二附属医院

Primary sponsor's address：

The Second Affiliated Hospital of Kunming Medical University, Yunnan-Burma Avenue, Wuhua District, Kunming City, Yunnan 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)：

云南省

市(区县)：

Country：

China

Province：

Yun Nan

City：

单位(医院)：

昆明医科大学第二附属医院

具体地址：

云南省昆明市五华区滇缅大道昆明医科大学第二附属医院

Institution
hospital：

The Second Affiliated Hospital of Kunming Medical University

Address：

The Second Affiliated Hospital of Kunming Medical University, Yunnan-Burma Avenue, Wuhua District, Kunming City, Yunnan Province, China

经费或物资来源：

昆明医科大学护理学院研究生院

Source(s) of funding：

Graduate School of Nursing School, Kunming Medical University

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

深入了解达芬奇机器人手术护士学习过程中的需求和困难；通过学员和教师层面的双向调研，构建科学的培训方案；利用建构主义学习理论，“情景”中拟采用虚拟仿真技术创新培训方式，提高机器人辅助系统手术患者的治疗效果。  

Objectives of Study：

To deeply understand the needs and difficulties in the learning process of Da Vinci robotic surgery nurses; A scientific training program was constructed through two-way investigation of students and teachers. Based on the constructivist learning theory, virtual simulation technology is proposed to innovate the training method in the "scenario" to improve the treatment effect of patients undergoing robot-assisted surgery.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

报名参加云南省手术室专科培训基地举办的为期不少于8周的手术室专科护士培训班，并被录取的注册护士；自愿加入本研究能够配合各项实验和教学，均知情同意并签署知情同意书。

Inclusion criteria

Registered nurses who were enrolled in the Operating Room specialist nurse training course held by the Operating Room specialist Training Base of Yunnan Province for a period of not less than 8 weeks and were admitted; All patients who volunteered to participate in this study were able to cooperate with the experiments and teaching, and all of them signed the informed consent form.

排除标准：

已经持有手术室专科护士证书的护士；具有达芬奇机器人手术护理配合实践经验的学员。

Exclusion criteria：

Nurses who have already held the operating room specialist nurse certificate; Students with practical experience of Da Vinci robotic surgical nursing cooperation.

研究实施时间：

Study execute time：

从 From 2024-12-30 00:00:00至 To 2025-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-12-30 00:00:00 至 To 2025-01-31 00:00:00  

干预措施：

Interventions：

组别：

虚拟仿真教学组

样本量：

27

Group：

Virtual simulation teaching group

Sample size：

干预措施：

基于建构主义学习理论的机器人专科护士虚拟仿真实践培训

干预措施代码：

Intervention：

Virtual simulation practice training for robot specialist nurses based on constructivism learning theory

Intervention code：

组别：

对照组

样本量：

27

Group：

Control group

Sample size：

干预措施：

采用传统授课法和观摩带教培训

干预措施代码：

Intervention：

Traditional teaching method and observation teaching training were adopted

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南省 

市(区县)：

  

Country：

China 

Province：

Yun Nan 

City：

 

单位(医院)：

昆明医科大学第二附属医院 

单位级别：

三甲 

Institution
hospital：

The Second Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

模拟操作考核成绩

指标类型：

主要指标

Outcome：

Results of simulation operation assessment and theoretical knowledge assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

理论知识考核成绩

指标类型：

主要指标

Outcome：

Theoretical knowledge assessment results

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

模拟操作考核时间

指标类型：

次要指标

Outcome：

Simulation operation examination time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

学员评判性思维能力

指标类型：

次要指标

Outcome：

Students' critical thinking ability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

案例分析考核

指标类型：

次要指标

Outcome：

Case analysis assessment

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 55 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）：

研究者采用区组随机化的单盲实验设计，由一位资深护士作为结果评估者，来评估两组护士进行的案例分析。这位护士并不知道各组的分配情况。对照组的护士首先被纳入研究，以确保两组之间没有信息交流。此外，干预组中的每位护士都被指示不要与同组的其他护士讨论与课程相关的信息。

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

We employed a single-blind experimental design, using the block method and a computerized list of random numbers. with a senior nurse serving as the outcome evaluator, to assess the case analysis conducted by two groups of nurses. The nurse was kept unaware of the group assignments. The nurses in the control group were enrolled in the study first to ensure no exchange of information between the two groups. Additionally, each nurse in the intervention group was instructed not to engage in discussions regarding course-related information with their counterparts within the same group.

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：

单盲实验设计，由一位资深护士作为结果评估者，来评估两组护士进行的案例分析。

Blinding：

We employed a single-blind experimental design, with a senior nurse serving as the outcome evaluator, to assess the case analysis conducted by two groups of nurses. The nurse was kept unaware of the group assignments. The nurses in the control group were enrolled in the study first to ensure no exchange of information between the two groups. Additionally, each nurse in the intervention group was instructed not to engage in discussions regarding course-related information with their counterparts within the same 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

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）：

科室内部共享，电子采集和管理系统（Electronic Data Capture， EDC）

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

Electronic Data Capture, EDC

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：

电子采集和管理系统（Electronic Data Capture， EDC）

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

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：

  2024-12-17 17:16:20