ChiCTR2500108719 版本V1.0 版本创建时间2025/09/04 08:26:24 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：

 ChiCTR2500108719 

最近更新日期：

Date of Last Refreshed on：

 2025-09-04 08:26:19 

注册时间：

Date of Registration：

 2025-09-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于LEARNS模式的泌尿系结石术后留 置双J管患者健康教育方案的构建及应用

Public title：

Development and Application of a Health Education Program Based on the LEARNS Model for Patients with Ureteral Stents Following Urolithiasis Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于LEARNS模式的泌尿系结石术后留置双J管患者健康教育方案的构建及应用

Scientific title：

Development and Application of a Health Education Program Based on the LEARNS Model for Patients with Ureteral Stents Following Urolithiasis Surgery

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：

王三姗 

研究负责人：

刘俊/王三姗 

Applicant：

Wang Sanshan 

Study leader：

Liu Jun/Wang sanshan 

申请注册联系人电话：

Applicant telephone：

 +86 189 7250 7812

研究负责人电话：

Study leader's
telephone：

+86 189 7250 7812

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：

 2451919789@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 2451919789@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：

湖北省十堰市茅箭区朝阳中路39号

研究负责人通讯地址：

湖北省十堰市茅箭区朝阳中路39号

Applicant address：

No. 39, Chaoyang Middle Road, Maojian District, Shiyan City, Hubei Province

Study leader's address：

No. 39, Chaoyang Middle Road, Maojian District, Shiyan City, Hubei Province

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：

十堰市人民医院(湖北医药学院附属人民医院)

Applicant's institution：

Shiyan People's Hospital (Affiliated People's Hospital of Hubei Medical University)

研究负责人所在单位：

十堰市人民医院(湖北医药学院附属人民医院)

Affiliation of the Leader：

Shiyan People's Hospital (Affiliated People's Hospital of Hubei Medical University)

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：

 SYRMYY-2025-076

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：

十堰市人民医院科研学术伦理专业委员会

Name of the ethic committee：

The Professional Committee of Scientific Research and Academic Ethics of Shiyan People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-08 00:00:00

伦理委员会联系人：

张蔷

Contact Name of the ethic committee：

Zhang Qiang

伦理委员会联系地址：

湖北省十堰市茅箭区朝阳中路39号

Contact Address of the ethic committee：

No. 39, Chaoyang Middle Road, Maojian District, Shiyan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 719 863 7035

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：

湖北省十堰市人民医院

Primary sponsor：

Shiyan People's Hospital, Hubei Province

研究实施负责（组长）单位地址：

湖北省十堰市茅箭区朝阳中路39号

Primary sponsor's address：

No. 39, Chaoyang Middle Road, Maojian District, Shiyan City, Hubei 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)：

湖北

市(区县)：

十堰

Country：

China

Province：

Hubei

City：

Shiyan

单位(医院)：

十堰市人民医院

具体地址：

湖北省十堰市茅箭区朝阳中路39号

Institution
hospital：

Shiyan People's Hospital, Hubei Province

Address：

No. 39, Chaoyang Middle Road, Maojian District, Shiyan City, Hubei Province

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

泌尿系结石  

Target disease：

Urolithiasis

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：

本研究通过文献回顾、小组讨论及专家函询，构建基于LEARNS模式的泌尿系结石术后留置双J管患者健康教育方案。探讨基于LEARNS模式的健康教育对泌尿系结石术后留置双J管患者自我管理、生活质量及并发症发生率的应用效果。  

Objectives of Study：

In this study, through literature review, group discussion and expert consultation, a health education program for patients with indwelling double-J stent after urinary calculi surgery based on the LEARNS model was constructed. To explore the application effect of health education based on the LEARNS model on self-management, quality of life and complication rate of patients with indwelling double-J catheters after urinary calculi 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：

1.首次行泌尿系结石手术，术后留置双J管的患者； 2.留置双J管时间为一个月的患者； 3.使用同一种型号、厂家的双J管； 4.年龄>=18岁； 5.具备一定的阅读和理解能力，无沟通、听力障碍； 6.自愿参与本研究并签署知情同意书。

Inclusion criteria

1. Patients who underwent urinary stone surgery for the first time and had double J tubes in place after surgery; 2. Patients who have been in place for one month with double J tubes; 3. Use the same model and manufacturer's double J pipe; 4. Age>=18 years old; 5. Have certain reading and comprehension skills, no communication or hearing impairment; 6. Volunteer to participate in this study and sign the informed consent form.

排除标准：

1.患有精神疾病病史的患者； 2.患有其他严重躯体疾病的患者（如肿瘤、免疫系统疾病等）； 3.有患侧输尿管手术史； 4.术前感染者； 5.无法配合本研究或中途退出者。

Exclusion criteria：

1. Patients with a history of mental illness; 2. Patients with other serious physical diseases (such as tumors, immune system diseases, etc.); 3. History of ureteral surgery on the affected side; 4. Preoperative infection; 5. Those who are unable to cooperate with this study or withdraw midway.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-04 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 58

Group：

Intervention group

Sample size：

干预措施：

干预组在常规护理的基础上实施基于LEARNS模式的健康教育干预。研究小组在文献研究的基础上，参考相关指南等，结合临床实际进行集体讨论，并进行咨询专家的基础，最终制作健康教育手册、PPT、视频、图片、思维导图等资料，确保各阶段不同教育方式的内容保持统一，供患者学习。

干预措施代码：

Intervention：

The intervention group implemented health education intervention based on the LEARNS model on the basis of routine care. Based on literature research, referring to relevant guidelines and other references, the research team conducted collective discussions in combination with clinical practice and consulted experts. Eventually, they produced health education manuals, PPTS, videos, pictures, mind maps and other materials to ensure that the content of different educational methods at each stage remains consistent for patients to learn from.

Intervention code：

组别：

对照组

样本量：

 58

Group：

Control group

Sample size：

干预措施：

对照组接受泌尿外科常规健康教育，以口头宣教为主，发放纸质版宣传手册、观看视频等为辅。患者住院期间护士给予人文关怀，并为其进行入院指导，对患者进行泌尿系结石疾病、相关手术、留置双J管、引流管护理、留置双J管后自我管理行为指导、日常生活管理相关基础知识，并为患者发放健康教育手册；患者出院前责任护士对患者进行出院宣教，包括居家带双J管的自我维管行为，如体位、饮食、运动等要求和拔管的注意事项并定期复查，为患者提供科室电话，让患者有问题及时打电话进行咨询；宣教过程以医护为主，由当班责任护士成员负责到床边，针对教育知识给予讲解与动作示范。时间为患者入院术后第一天至出院当天。以及离院后电话随访2周一次，并督促其按时返院复查与取管，干预时间为一个月。

干预措施代码：

Intervention：

The control group received routine health education in urology, mainly through oral education, supplemented by the distribution of paper promotional brochures and watching videos, etc. During the patient's hospitalization, the nurse provided humanistic care and admission guidance for the patient, including care for urinary calculi diseases, related surgeries, indwelling double-J tubes, drainage tubes, self-management behaviors after indwelling double-J tubes, and basic knowledge related to daily life management. The nurse also distributed health education handbooks to the patient. Before the patient is discharged from the hospital, the responsible nurse provides discharge education to the patient, including self-maintenance behaviors for wearing double J tubes at home, such as requirements for position, diet, exercise, etc., as well as precautions for extubation, and conducts regular follow-ups. The nurse also provides the patient with the department's phone number, allowing the patient to call for consultation in a timely manner if they have any questions. The educational process is mainly carried out by medical staff. The on-duty nurse members are responsible for going to the bedside to explain the educational knowledge and demonstrate the actions. The period is from the first day after the patient's admission to the day of discharge. After discharge, they will be followed up by phone every two weeks and urged to return to the hospital on time for re-examination and tube removal. The intervention period is one month.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 十堰市 

Country：

China

Province：

Hubei

City：

Shiyan

单位(医院)：

 十堰市人民医院(湖北医药学院附属人民医院) 

单位级别：

 三甲 

Institution
hospital：

Shiyan People's Hospital (Affiliated People's Hospital of Hubei Medical University)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自我管理能力

指标类型：

主要指标

Outcome：

Self-management skills

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Living quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

并发症发生率

指标类型：

次要指标

Outcome：

Incidence of complications

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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）：

采取单盲抽签法将患者随机分组：在一个不透明纸箱中放入1～116号数字签，抽到1～58号的患者分为对照组，抽到59～116号的患者分为干预组。根据随机数对应的序号将研究对象纳入对照组和实验组。若纳入实验组与对照组的患者刚好在同一病房，则进行病房的调整，避免实验组和对照组在同一房间，若无法调整，则将其剔除研究。

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

The patients were randomly divided into groups by single-blind lottery method: the number 1~116 was put into an opaque carton, the patients drawn with numbers 1~58 were divided into the control group, and the patients with numbers 59~116 were divided into the intervention group. The study subjects were included in the control group and the experimental group according to the serial number corresponding to the random number. If the patients included in the experimental group and the control group happen to be in the same ward, the ward should be adjusted to avoid the experimental group and the control group being in the same room, and if it cannot be adjusted, they will be excluded from the study.

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，对研究参与者设盲

Blinding：

Single blind, blinded to study participants

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

否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：

EDC

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

  2025-09-04 08:26:19