ChiCTR2500107408 版本V1.0 版本创建时间2025/08/11 14:12:49 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：

ChiCTR2500107408 

最近更新日期：

Date of Last Refreshed on：

2025-08-11 14:12:31 

注册时间：

Date of Registration：

2025-08-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

虚拟模拟技术在产前超声专科医师技能培训与考核中的研究应用

Public title：

The Research Application of Virtual Simulation Technology in Skills Training and Assessment of Prenatal Ultrasound Specialists

注册题目简写：

English Acronym：

研究课题的正式科学名称：

虚拟模拟技术在产前超声专科医师技能培训与考核中的研究应用

Scientific title：

The application of virtual simulation technology in the skill training and assessment of prenatal ultrasound physicians

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：

赵永峰 

研究负责人：

周平 

Applicant：

Yongfeng Zhao 

Study leader：

Ping Zhou 

申请注册联系人电话：

Applicant telephone：

+86 150 8489 1696

研究负责人电话：

Study leader's telephone：

+86 139 7480 9881

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：

redscv@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zhouping1000@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www.xy3yy.com/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.xy3yy.com/

申请注册联系人通讯地址：

湖南省长沙市岳麓区中南大学湘雅三医院超声科

研究负责人通讯地址：

湖南省长沙市岳麓区中南大学湘雅三医院超声科

Applicant address：

Department of Ultrasound, The Third Xiangya Hospital of Central South University, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

Department of Ultrasound, The Third Xiangya Hospital of Central South University, Yuelu District, Changsha City, Hunan 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：

中南大学湘雅三医院

Applicant's institution：

The Third Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅三医院

Affiliation of the Leader：

The Third Xiangya Hospital of Central South 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：

2020-S375

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

The IRB of Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

2020-08-11 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin Wang

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院科教大楼伦理委员会办公室（410013）

Contact Address of the ethic committee：

Ethics Committee Office, Science and Education Building, The Third Xiangya Hospital, No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan Province (410013)

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 8861 8938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

xy3irb@163.com

研究实施负责（组长）单位：

中南大学湘雅三医院

Primary sponsor：

The Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138, Tongzipo Road, Yuelu District, Hexi District, Changsha City, Hunan 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)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅三医院

具体地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Institution
hospital：

The Third Xiangya Hospital of Central South University

Address：

No. 138, Tongzipo Road, Yuelu District, Hexi District, Changsha City, Hunan Province

经费或物资来源：

湖南省“十四五”教育科学规划项目 (XJK21AGD002)

Source(s) of funding：

Project of the 14th five year plan of Educational Science in Hunan Province (XJK21AGD002)

Target disease：

Routine Second-Trimester Prenatal Screening

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：

模拟虚拟技术的发展，为医学教育提供了一条新的途径。传统的超声教学方式存在一定的缺陷，培训实践机会有限，理论与实践教学脱节，经验积累不足，而且往往存在伦理学问题。考核方法亦存在缺陷，考核内容不全面，考核那一做到同质化，考核的主观性强，信度差。本项目尝试将模拟虚拟技术应用于产前超声实践技能培训考核中，来探究虚拟模拟技术考核的效度、信度、难度以及区分度，并与志愿者孕妇考核方式进行对比。本项目还应用虚拟模拟技术技术培训与传统志愿者孕妇培训对比，来观察两种方法对学员考核成绩的提升能力，以及模拟环境下技能的学习能否向真实临床能力进行转化。以期望为产前超声实践技能培训与考核开拓了新的思路。  

Objectives of Study：

The development of simulation and virtual technologies has opened a new path for medical education. Traditional ultrasound teaching methods have certain limitations, such as limited hands-on training opportunities, a disconnect between theoretical and practical teaching, insufficient experience accumulation, and frequent ethical concerns. The current assessment methods also have shortcomings, including incomplete coverage, lack of standardization, high subjectivity, and low reliability. This project attempts to apply simulation and virtual technologies to the training and assessment of prenatal ultrasound skills, aiming to explore the validity, reliability, difficulty, and discrimination of assessments using simulation-based methods, in comparison with assessments conducted on volunteer pregnant women. Furthermore, the project compares simulation-based training with traditional training using volunteer pregnant women to observe the improvement in trainees’ assessment performance under both approaches, and to evaluate whether skills acquired in a simulated environment can transfer to real clinical competence. The goal is to provide new perspectives for the training and assessment of prenatal ultrasound practice.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

已完成一年以上培训且尚未独立进行过常规中期胎儿超声检查的住院医师2年级和3年级学员。

Inclusion criteria

PGY-2 and PGY 3 trainees who had completed more than one year of training and had not yet independently conducted routine mid-trimester fetal ultrasound examinations.

排除标准：

没有任何超声知识以及无法操作超声设备的人员，以及之前接受过产科超声模拟训练的人员。

Exclusion criteria：

The exclusion criteria included individuals without any ultrasound knowledge and the inability to operate ultrasound equipment, as well as those who had previously undergone obstetric ultrasound simulation training.

研究实施时间：

Study execute time：

从 From 2020-10-31 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-11-02 00:00:00 至 To 2021-04-02 00:00:00  

干预措施：

Interventions：

组别：

传统组

样本量：

22

Group：

traditional group

Sample size：

干预措施：

传统组学员通过志愿者孕妇来进行培训。培训课程依据《常规中期胎儿超声扫描操作指南》制定，并分为四个不同的任务模块，还包括一个综合培训课程。每个培训小组由 3 至 4 名参与者组成。起初，指导者会在模拟器或志愿者孕妇身上演示操作步骤。演示结束后，参与者轮流练习这些技术。为避免疲劳，每位参与者的连续练习时间限制在 30 分钟以内，每个模块的总练习时间设定为 1 小时，以便进行反复练习。每位孕妇的扫描时间不超过 30 分钟，以遵循 ALARA 原则，尽量减少辐射暴露。完成练习后，参与者需要观察其他人的操作。在整个过程中，参与者都有机会从指导老师那里获得指导和反馈。每个任务模块都遵循这种结构，整个培训时长为 5 小时。

干预措施代码：

Intervention：

The traditional group trainees were trained using volunteer pregnant women. The training course was designed based on the Guidelines for Routine Mid-Trimester Fetal Ultrasound Scan and divided into four distinct task modules, along with a comprehensive training session. Each training group consisted of 3 to 4 participants. Initially, the instructor demonstrated the operational steps on a simulator or a volunteer pregnant woman. After the demonstration, the participants took turns practicing these techniques. To prevent fatigue, each participant's continuous practice time was limited to no more than 30 minutes, and the total practice time for each module was set at 1 hour to allow for repeated practice. Each pregnant woman’s scanning time did not exceed 30 minutes to adhere to the ALARA principle (As Low As Reasonably Achievable) and minimize radiation exposure. After completing the practice, participants were required to observe the operations of others. Throughout the process, participants had the opportunity to receive guidance and feedback from the instructor. Each task module followed this structure, and the entire training duration was 5 hours.

Intervention code：

组别：

模拟器组

样本量：

22

Group：

simulator group

Sample size：

干预措施：

模拟器组中，学员技能训练使用Simbionix U/S 模拟器进行培训。培训课程依据《常规中期胎儿超声扫描操作指南》制定，并分为四个不同的任务模块，还包括一个综合培训课程。每个培训小组由 3 至 4 名参与者组成。起初，指导者会在模拟器或志愿者孕妇身上演示操作步骤。演示结束后，参与者轮流练习这些技术。为避免疲劳，每位参与者的连续练习时间限制在 30 分钟以内，每个模块的总练习时间设定为 1 小时，以便进行反复练习。每位孕妇的扫描时间不超过 30 分钟，以遵循 ALARA 原则，尽量减少辐射暴露。完成练习后，参与者需要观察其他人的操作。在整个过程中，参与者都有机会从指导老师那里获得指导和反馈。每个任务模块都遵循这种结构，整个培训时长为 5 小时。

干预措施代码：

Intervention：

In the simulator group, trainees underwent skill training using the Simbionix U/S simulator. The training course was designed based on the Guidelines for Routine Mid-Trimester Fetal Ultrasound Scan and divided into four distinct task modules, along with a comprehensive training session. Each training group consisted of 3 to 4 participants. Initially, the instructor demonstrated the operational steps on the simulator or a volunteer pregnant woman. After the demonstration, participants took turns practicing these techniques. To prevent fatigue, each participant's continuous practice time was limited to no more than 30 minutes, and the total practice time per module was set at 1 hour to allow for repeated practice. For volunteer pregnant women, scanning time did not exceed 30 minutes to comply with the ALARA principle (As Low As Reasonably Achievable), minimizing unnecessary exposure. After completing their practice, participants observed others' operations. Throughout the process, they received guidance and feedback from the instructor. Each task module followed this structure, and the entire training duration was 5 hours.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China 

Province：

Hunan 

City：

Changsha 

单位(医院)：

中南大学湘雅三医院 

单位级别：

三级甲等 

Institution
hospital：

The Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

产科超声能力评估工具（OUCAT）

指标类型：

主要指标

Outcome：

obstetric ultrasound competency assessment tool(OUCAT)

Type：

Primary indicator

测量时间点：

测量方法：

通过产科超声能力评估工具（OUCAT）来评估参与者在测试前后的技能水平，共包含 11个部分中的123个项目。11个项目分别为检查前准备、一般情况、颅脑、颜面部、颈部、胸部、心脏、腹部、脊柱、四肢、胎儿附属物、母体子宫附件以及额外评价。评分细则按照单项0/1分；缺项不给分，0=未进行/未完全按要求进行，1=完全按要求进行。

Measure time point of outcome：

Measure method：

The skills of the participants before and after the test were evaluated through the Obstetric Ultrasound Competency Assessment Tool (OUCAT), which consists of 123 items in 11 sections. The 11 sections are pre-examination preparation, general condition, cranium and brain, face and neck, chest, heart, abdomen, spine, limbs, fetal appendages, maternal uterus and adnexa, and additional evaluation. The scoring criteria are 0/1 points for each item; no points are given for missing items, where 0 indic

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

本研究采用完全随机化（Simple Randomization）方法，将参与者以1:1比例分配至“虚拟模拟培训组”或“传统临床培训组”。随机分组由一名独立研究人员使用SPSS 26.0软件生成随机数字序列后实施，以确保分组过程的客观性与可重复性。

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

This study employed a simple randomization method to allocate participants in a 1:1 ratio to either the "virtual simulation training group" or the "traditional clinical training group". The randomization was conducted by an independent researcher who generated a random number sequence using SPSS 26.0 software to ensure the objectivity and reproducibility of the allocation process.

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：

由于本研究两组干预方式在形式与过程上存在显著差异（虚拟模拟器操作与真实孕妇临床扫描），因此无法实现盲法控制，包括参与者盲法与培训执行者盲法均不可行。此外，干预性质的显著不同也使分组难以隐蔽。尽管如此，为尽可能降低非盲法带来的偏倚风险，研究将采取以下措施： （1）评估人员盲法：最终技能考核由不知晓参与者培训分组的评估者（blinded assessor）独立完成，评估内容为标准化模拟案例或客观结构化考核（如OSCE），以提高评估的客观性和一致性。 （2）统一评估标准：所有学员培训结束后将接受相同内容和评分标准的技能考核，避免因评估过程差异引入偏倚。 （3）流程标准化：无论培训组别，教学时间、培训目标、教学大纲和评估时间点均保持一致，以确保研究的可比性。 综上，虽然本研究无法实行干预盲法，但通过独立随机分组、评估人员盲法以及统一流程控制，仍可在一定程度上保障研究的科学性与内部效度。

Blinding：

Due to the significant differences in form and process between the two intervention methods in this study (virtual simulator operation and real clinical scanning of pregnant women), it is impossible to implement blinding control, including both participant blinding and trainer blinding. Moreover, the substantial differences in the nature of the interventions also make it difficult to conceal the group allocation. Nevertheless, to minimize the risk of bias caused by non-blinding as much as possible, the following measures will be taken in the study: (1) Blinded assessment: The final skill assessment will be independently conducted by assessors who are unaware of the participants' training groups. The assessment will be based on standardized simulation cases or objective structured clinical examinations (OSCE) to enhance the objectivity and consistency of the evaluation. (2) Uniform assessment criteria: All trainees will undergo the same content and scoring standards for skill assessment after training to avoid introducing bias due to differences in the assessment process. (3) Standardized procedures: Regardless of the training group, the teaching time, training objectives, teaching syllabus, and assessment time points will remain consistent to ensure the comparability of the study. In conclusion, although blinding in the intervention cannot be implemented in this study, the scientific nature and internal validity of the research can still be guaranteed to a certain extent through independent random grouping, blinded assessment, and standardized procedures.

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）：

本研究计划在主要结果发表后6个月内，即预计于2026年12月31日前，通过ResMan原始数据共享平台公开共享去标识化的原始数据。共享数据包括主要结局指标和关键变量，数据文件将附带变量说明和数据字典，以便于再分析和验证。所有共享数据将在伦理审查和脱敏处理后上传，确保不泄露受试者隐私。共享平台名称：ResMan原始数据共享平台 共享平台网址：http://www.medresman.org.cn/

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

This research plan aims to make the de-identified original data publicly available through the ResMan original data sharing platform within 6 months after the publication of the main results, which is expected to be before December 31, 2026. The shared data will include the main outcome indicators and key variables. The data files will be accompanied by variable descriptions and data dictionaries for re-analysis and verification. All shared data will be uploaded after undergoing ethical review and de-sensitization processing to ensure that the privacy of the participants is not compromised. The name of the sharing platform: ResMan Original Data Sharing Platform. The website of the sharing platform: http://www.medresman.org.cn/

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：

本研究将采用纸质版病例记录表（Case Record Form, CRF）进行数据初步采集，所有临床观察指标、实验室结果和随访信息均由研究人员在CRF中如实记录。随后，数据将统一录入至基于互联网的电子数据采集与管理系统（Electronic Data Capture, EDC）——ResMan平台（http://www.medresman.org.cn/）中进行管理。EDC系统将用于数据的集中存储、质量控制与权限管理，具备数据录入校验、审核追踪及数据导出功能，有助于提高数据准确性和完整性，确保试验数据的可追溯性和安全性。

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

This study will initially collect data using a paper-based case record form (CRF). All clinical observation indicators, laboratory results, and follow-up information will be accurately recorded by the researchers in the CRF. Subsequently, the data will be uniformly entered into the Internet-based electronic data capture and management system (Electronic Data Capture, EDC) - the ResMan platform (http://www.medresman.org.cn/) for management. The EDC system will be used for centralized data storage, quality control, and permission management. It has functions such as data entry verification, tracking of reviews, and data export, which help improve data accuracy and completeness, and ensure the traceability and security of the trial data.

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：

  2025-08-11 14:12:31