ChiCTR2500105340 版本V1.0 版本创建时间2025/07/02 09:14:58 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：

 ChiCTR2500105340 

最近更新日期：

Date of Last Refreshed on：

 2025-07-02 09:13:57 

注册时间：

Date of Registration：

 2025-07-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Deepseek在全膝关节置换术知情同意过程中缓解焦虑中的作用：一项随机对照试验试点研究

Public title：

The Role of Deepseek in Alleviating Anxiety during the Informed Consent Process for Total Knee Arthroplasty: A Pilot Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Deepseek在全膝关节置换术知情同意过程中缓解焦虑中的作用：一项随机对照试验试点研究

Scientific title：

The Role of Deepseek in Alleviating Anxiety during the Informed Consent Process for Total Knee Arthroplasty: A Pilot Randomized Controlled Trial

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：

梁家琛 

研究负责人：

李政 

Applicant：

Jiachen Liang 

Study leader：

Zheng Li 

申请注册联系人电话：

Applicant telephone：

 +86 182 3421 1566

研究负责人电话：

Study leader's
telephone：

+86 159 2996 1629

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：

 liangjiachen.com@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1214082016@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：

西安市碑林区南稍门友谊东路555号

研究负责人通讯地址：

西安市碑林区南稍门友谊东路555号

Applicant address：

No. 555, Friendship East Road, Nan Xiaomen, Beilin District, Xi'an City

Study leader's address：

No. 555, Friendship East Road, Nan Xiaomen, Beilin District, Xi'an City

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：

西安市红会医院

Applicant's institution：

Xi'an Honghui Hospital

研究负责人所在单位：

西安市红会医院

Affiliation of the Leader：

Xi'an Honghui Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025-KY-113-01

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：

西安交通大学附属红会医院/西安市红会医院伦理委员会

Name of the ethic committee：

the ethics committee of Xi'an Jiaotong University Affiliated Honghui Hospital/Xi'an Honghui Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-13 00:00:00

伦理委员会联系人：

蒋凯

Contact Name of the ethic committee：

Kai Jiang

伦理委员会联系地址：

西安市友谊东路555号 西安市红会医院号楼2楼药物临床试验机构办公室

Contact Address of the ethic committee：

Office of the Drug Clinical Trial Institution, 2nd Floor, Building of Xi'an Honghui Hospital, No. 555, Friendship East Road, Xi'an City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 181 8919 0408

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：

西安市红会医院

Primary sponsor：

Xi'an honghui Hospital

研究实施负责（组长）单位地址：

西安市碑林区南稍门友谊东路 555 号

Primary sponsor's address：

No. 555, Youyi East Road, Naanshaomen, Beilin District, Xi'an City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

西安市

Country：

China

Province：

Shaanxi Province

City：

Xi’an

单位(医院)：

红会医院

具体地址：

西安市碑林区南稍门友谊东路555号

Institution
hospital：

Honghui Hospital

Address：

No. 555, Youyi East Road, Naanshaomen, Beilin District, Xi'an City

经费或物资来源：

西安市红会医院

Source(s) of funding：

Xi'an honghui Hospital

研究疾病：

膝关节骨性关节炎  

Target disease：

knee osteoarthritis

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：

这项研究的目的是评估在全膝关节置换术（TKA）的知情同意过程中使用Deepseek对患者围手术期焦虑的影响。具体来说，研究旨在探索Deepseek在提高患者教育质量和改善患者满意度方面的潜力。  

Objectives of Study：

The aim of this study is to evaluate the impact of using Deepseek during the informed consent process for total knee arthroplasty (TKA) on patients' perioperative anxiety. Specifically, the study aims to explore the potential of Deepseek in enhancing the quality of patient education and improving patient satisfaction.

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）年龄：45至80岁。 （2）诊断：患有膝关节骨关节炎（OA），在过去一个月内有反复的膝关节疼痛。 （3）症状：平均晨僵时间小于30分钟，偶尔有骨摩擦音。 （4）放射学标准：术前全长站立X光片显示Kellgren-Lawrence分级为IV级。 （5）保险：由员工或居民医疗保险覆盖。 （6）家庭支持：术前同意时有50岁以下家庭成员在场。

Inclusion criteria

1.Age: 45 to 80 years old; 2. Diagnosis: Suffering from knee joint osteoarthritis (OA), with recurrent knee pain in the past month; 3. Symptoms: The average morning stiffness lasts less than 30 minutes, and there are occasional bone friction sounds; 4. Radiological criteria: The preoperative full-length standing X-ray shows a Kellgren-Lawrence grade of IV; 5. Insurance: Covered by employee or resident medical insurance; 6. Family support: When the consent is given before the surgery, family members under the age of 50 are present.

排除标准：

（1）心理健康：存在精神障碍。 （2）其他疼痛：主要诉求是髋关节或下背痛，或有全髋关节置换史。 （3）手术史：有膝关节侧副韧带重建或股骨远端或胫骨近端截骨史。 （4）身体状况：体重指数（BMI）大于30 kg/m2，肌力小于III级，轮椅使用超过3个月。 （5）神经肌肉疾病：脊髓灰质炎后遗症、帕金森病。 （6）认知障碍：阿尔茨海默病或脑萎缩。 （7）关节状况：Charcot关节、严重的膝内翻（>30°）或膝外翻畸形、关节外畸形（>10°）。 （8）术后问题：如无菌假体移位、假体周围骨折、感染或切口不愈合等并发症。

Exclusion criteria：

1.Mental health: Presence of mental disorders; 2. Other pain: Main complaints are hip joint or lower back pain, or a history of total hip replacement; 3.Surgical history: History of lateral collateral ligament reconstruction of the knee joint or osteotomy of the distal femur or proximal tibia; 4.Physical condition: Body mass index (BMI) greater than 30 kg/m2, muscle strength less than level III, use of wheelchair for more than 3 months; 5.Neuromuscular diseases: Post-polio sequelae, Parkinson's disease; 6.Cognitive impairment: Alzheimer's disease or brain atrophy; 7. Joint condition: Charcot joint, severe genu varum (>30°) or genu valgum deformity, joint deformity outside the joint (>10°); 8. Postoperative problems: Complications such as sterile prosthesis displacement, prosthesis-related fractures, infection or non-healing of the incision.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2025-10-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-20 00:00:00 至 To 2025-10-30 00:00:00

干预措施：

Interventions：

组别：

Deepseek辅助下手术前医患交谈模式

样本量：

 30

Group：

The preoperative doctor-patient communication model assisted by Deepseek

Sample size：

干预措施：

在面对分配至该组的患者时，主刀医生首先会详细说明患者的当前病情，以及为何需要进行TKA手术。此后，医生会依据术前谈话资料，向患者及家属清晰地描述TKA手术的流程以及术后病情的恢复情况，这部分操作与对照组相同。接下来，主刀医生会向患者及家属介绍DeepSeek这一工具，并将患者及家属提出的问题进行文本整理后输入DeepSeek。随后，医生会对DeepSeek生成的回答进行解读，并结合自身丰富的临床经验，对回答内容进行进一步的补充和阐释。最终，在患者及家属对整个治疗方案完全理解且没有任何疑问的情况下，医生会指导患者签署“手术知情同意书”。

干预措施代码：

Intervention：

When dealing with the patients assigned to this group, the surgeon will first provide a detailed explanation of the patient's current condition and the reasons for the TKA surgery. Subsequently, based on the preoperative discussion materials, the doctor will clearly describe the process of the TKA surgery and the recovery of the patient's condition after the surgery to the patient and their family. This part of the operation is the same as the control group. Next, the surgeon will introduce the DeepSeek tool to the patient and their family, and organize the questions raised by the patient and family into text form and input them into DeepSeek. Then, the doctor will interpret the answers generated by DeepSeek and, based on their rich clinical experience, further supplement and explain the content. Finally, when the patient and their family fully understand the entire treatment plan and have no questions, the doctor will guide the patient to sign the "Surgical Informed Consent Form".

Intervention code：

组别：

传统手术前医患交谈模式

样本量：

 30

Group：

The traditional mode of doctor-patient communication before surgery

Sample size：

干预措施：

本科室为即将接受TKA手术的患者准备的术前谈话资料包括《TKA宣传手册》和《典型病例集》，内容涵盖手术流程、假体类型、本科室的成功病例以及近期和远期随访情况等。对于分配至该组的患者，主刀医生首先会结合患者的体格检查和影像学检查结果，详细说明其当前病情及选择TKA手术的必要性。接着，医生会借助术前谈话资料，向患者及家属科普TKA手术的全过程，并对术后恢复情况进行合理预测。在沟通过程中，医生会耐心解答患者及家属提出的问题，确保他们对治疗方案完全理解。最终，在患者及家属对方案无任何疑问后，指导患者签署“手术知情同意书”。

干预措施代码：

Intervention：

The preoperative discussion materials prepared by this department for patients about to undergo TKA surgery include the "TKA Brochure" and the "Typical Case Collection". The content covers the surgical process, the types of prostheses, the successful cases of our department, as well as the recent and long-term follow-up situations. For the patients assigned to this group, the surgeon will first, based on the patient's physical examination and imaging examination results, explain in detail their current condition and the necessity of choosing TKA surgery. Then, the doctor will use the preoperative discussion materials to explain the entire process of TKA surgery to the patient and their family, and make reasonable predictions about the postoperative recovery. During the communication process, the doctor will patiently answer the questions raised by the patient and their family to ensure that they fully understand the treatment plan. Finally, after the patient and their family have no doubts about the plan, the doctor will guide the patient to sign the "Surgical Informed Consent Form".

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

 西安市 

Country：

China

Province：

Shaanxi Province

City：

Shaanxi

单位(医院)：

 红会医院 

单位级别：

 三级甲等 

Institution
hospital：

Honghui Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

医院焦虑和抑郁量表-焦虑分量表（HADS—A）

指标类型：

主要指标

Outcome：

Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS - A)

Type：

Primary indicator

测量时间点：

入院第1天、术前签署知情同意书后进行评估、术后第五天

测量方法：

量表

Measure time point of outcome：

On the first day of admission, after signing the informed consent form before the operation, the assessment was conducted, and on the fifth day after the operation

Measure method：

scale

指标中文名：

医院焦虑和抑郁量表-抑郁分量表（HADS—D）

指标类型：

主要指标

Outcome：

Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

Type：

Primary indicator

测量时间点：

入院第1天、术前签署知情同意书后进行评估、术后第五天

测量方法：

量表

Measure time point of outcome：

On the first day of admission, after signing the informed consent form before the operation, the assessment was conducted, and on the fifth day after the operation

Measure method：

scale

指标中文名：

围手术期焦虑量表-7（PAS-7）

指标类型：

主要指标

Outcome：

Perioperative Anxiety Scale - 7 (PAS-7)

Type：

Primary indicator

测量时间点：

入院第1天、术前签署知情同意书后进行评估

测量方法：

量表

Measure time point of outcome：

On the first day of admission, an assessment was conducted after signing the informed consent form before the operation.

Measure method：

scale

指标中文名：

视觉模拟量表-焦虑（VAS-A）

指标类型：

主要指标

Outcome：

Visual Analogue Scale - Anxiety (VAS-A)

Type：

Primary indicator

测量时间点：

入院第1天、术前签署知情同意书后进行评估、术后第五天

测量方法：

量表

Measure time point of outcome：

On the first day of admission, after signing the informed consent form before the operation, the assessment was conducted, and on the fifth day after the operation

Measure method：

scale

指标中文名：

西安大略和麦克马斯特大学骨关节炎指数

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index

Type：

Secondary indicator

测量时间点：

入院第1天、术后第五天

测量方法：

量表

Measure time point of outcome：

The first day of admission and the fifth day after surgery

Measure method：

scale

指标中文名：

视觉模拟量表-疼痛（VAS-P）

指标类型：

次要指标

Outcome：

Visual Analogue Scale - Pain (VAS-P)

Type：

Secondary indicator

测量时间点：

入院第1天、术后第五天

测量方法：

Measure time point of outcome：

The first day of admission and the fifth day after surgery

Measure method：

指标中文名：

一个问题的满意度问卷

指标类型：

次要指标

Outcome：

Single Item Overall Patient Satisfaction Questionnaire

Type：

Secondary indicator

测量时间点：

测试的时间点为患者出院当天

测量方法：

Measure time point of outcome：

The testing time point was on the day of the patient's discharge.

Measure method：

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

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 45 岁 years
最大 Max age 80 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）：

采用抽签法进行随机分组。首先，准备60根签条，每根签条上写上一个编号（1 - 60），其中1 - 30号签条标记为“A组”（Deepseek辅助下手术前医患交谈模式），31 - 60号签条标记为“B组”（传统手术前医患交谈模式）。将这些签条放入一个不透明容器中，由研究小组之外的护士负责充分混合。在患者住院后的第二天，由一名与研究小组无关的第三方人员闭眼从容器中随机抽取一根签条，查看签条上的编号和分组标记后，将该名患者的分组结果告知项目执行人甲和乙。

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

Random grouping was conducted by drawing lots. First, 60 slips of paper were prepared, each marked with a number from 1 to 60. Slips numbered 1 to 30 were labeled as "Group A" (Deepseek-assisted preoperative doctor-patient communication model), and those numbered 31 to 60 were labeled as "Group B" (traditional preoperative doctor-patient communication model). These slips were placed in an opaque container and thoroughly mixed by a nurse not affiliated with the research team. On the second day after the patients were admitted to the hospital, a third party not involved in the research team closed their eyes and randomly drew a slip from the container. After checking the number and group label on the slip, the group assignment of the patient was informed to Project Executives A and B.

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：

在本研究中，项目执行人甲、主刀医生们（负责与患者签署手术知情同意书并进行术前谈话）以及参与研究的患者均知晓分组情况。然而，为了消除人为偏见所导致的系统误差，我们对患者的主管医生、康复治疗师丙（负责指导患者术后康复）以及负责收集研究数据的医生实施了盲法。

Blinding：

In this study, Project Executor A, the surgeons (responsible for signing the informed consent forms with the patients and conducting preoperative discussions), and the patients participating in the research were all aware of the group allocation. However, to eliminate systematic errors caused by human bias, we implemented blinding for the patients' attending physicians, Rehabilitation Therapist C (responsible for guiding postoperative rehabilitation of the patients), and the doctors responsible for collecting research data.

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

是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）：

公开原始数据日期：2026年4月30日。公开原始数据的方式：网络平台：临床试验公共管理平台ResMan（http://www.medresman.org.cn/login.aspx）。

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

Date of public release of raw data: April 30, 2026. Method of public release of raw data: Online platform: Clinical Trial Public Management Platform ResMan (http://www.medresman.org.cn/login.aspx).

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：

使用SPSS 23.0（SPSS，芝加哥，伊利诺伊州，美国）软件包分析数据。 使用Mann-Whitney U检验分析非参数数据，分析两组之间客观和半客观测量的差异。 两位专家进行的半客观评估之间的一致性水平是由科恩的K系数估算的。 P <0.05被认为是显著的

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

Data were analyzed using the SPSS 26.0 (SPSS, Chicago, Illisnois, USA) software package. Differences in the objective and semi-objective measurements between the two groups were analyzed using the Mann-Whitney U test for non-parametric data. The level of agreement between the semi-objective assessments made by the two experts was estimated by Cohen's K co-efficient. P < 0.05 was considered significant.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-02 09:13:57