ChiCTR2500103215 版本V1.0 版本创建时间2025/05/27 09:05:13 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：

ChiCTR2500103215 

最近更新日期：

Date of Last Refreshed on：

2025-05-27 09:05:09 

注册时间：

Date of Registration：

2025-05-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

格林模式健康教育对心脏外科行开胸手术瓣膜置换患者疼痛管理中的应用研究

Public title：

Research on the application of Green's model health education in pain management in cardiac surgery patients undergoing thoracotomy for valve replacement

注册题目简写：

English Acronym：

研究课题的正式科学名称：

格林模式健康教育对心脏外科行开胸手术瓣膜置换患者疼痛管理中的应用研究

Scientific title：

Research on the application of Green's model health education in pain management in cardiac surgery patients undergoing thoracotomy for valve replacement

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：

李娜 

研究负责人：

李娜 

Applicant：

LI Na 

Study leader：

LI Na 

申请注册联系人电话：

Applicant telephone：

+86 156 2628 4611

研究负责人电话：

Study leader's telephone：

+86 156 2628 4611

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：

827553760@qq.com

研究负责人电子邮件：

Study leader's E-mail：

827553760@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：

广东省广州市越秀区中山二路58号

研究负责人通讯地址：

广东省广州市越秀区中山二路58号

Applicant address：

No. 58 Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 58 Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong 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：

中山大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Sun Yat sen University

研究负责人所在单位：

中山大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Sun Yat sen 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：

伦审临[2024]678 号

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：

中山大学附属第一医院临床科研和实验动物伦理委员会

Name of the ethic committee：

IEC for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-12-09 00:00:00

伦理委员会联系人：

张樊荣

Contact Name of the ethic committee：

Zhang Fanrong

伦理委员会联系地址：

广州市中山二路58号

Contact Address of the ethic committee：

No. 58 Zhongshan 2nd Road, Guangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8733 4871

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：

中山大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Sun Yat sen University

研究实施负责（组长）单位地址：

广东省广州市越秀区中山二路58号

Primary sponsor's address：

No. 58 Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong 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)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

单位(医院)：

中山大学附属第一医院

具体地址：

广东省广州市越秀区中山二路58号

Institution
hospital：

The First Affiliated Hospital of Sun Yat sen University

Address：

No. 58 Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

院级柯麟启航青苗项目

Source(s) of funding：

Academy Level Kelin sailing young crops project

Target disease：

Valvular heart disease

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：

调查对心脏外科开胸瓣膜置换患者疼痛管理不足的全方位的原因分析，基于格林模式剖析其影响因素，寻找其倾向因素、促成因素、强化因素，制定出健康教育干预方案。运用NRS疼痛评定量表（术1-术5、出院）、疼痛控制满意度、知信行问卷调查、首次下床时间评价其效果，为今后心脏外科开胸患者疼痛自我管理水平的提升提供临床依据。  

Objectives of Study：

To investigate the causes of inadequate pain management in patients with heart surgery with open chest valve replacement, analyze its influencing factors based on Green's model, find its tendency factors, contributing factors and strengthening factors, and formulate health education intervention programs. NRS pain rating scale (operation 1-operation 5, discharge), pain control satisfaction, knowledge and practice questionnaire, and time to get out of bed for the first time were used to evaluate the effect, which provided clinical basis for the improvement of pain self-management level in patients with cardiac surgery in the future.

药物成份或治疗方案详述：

1.患者术后疼痛程度：通过数字评分法（NRS）评估患者术后第1日-第5日疼痛程度，其中术后第2天作为主要终点。 2.患者知信行问卷调查：通过采用孙静[25]等人在2014年研制《疼痛知信行调查问卷》，本问卷编制了36个条目, 包括疼痛知识、疼痛信念、疼痛控制行为三个子问卷。患者疼痛知识问卷, 为判断题型, 正向题答对得1分, 其它不得分, 反向题答错得1分, 其它不得分, 满分为14分, 得分越高表示认知程度越好;患者疼痛信念问卷共15个条目,采用Linkert 5级评分法, 1~5分分别表示“非常同意”、“同意”、“一般”、“不同意”、“非常不同意”, 得分越高, 表示疼痛信念越趋于正向;患者疼痛控制行为问卷共7个条目, 为选择题采用Linkert 4级评分法, 1~4分分别表示“从不”、“很少”、“经常”、“总是”, 得分越高表示疼痛控制行为越好 3.患者术后首次下床时间:记录患者从手术结束到首次下床活动的具体时间间隔。时间段分为：24小时内、24h≤x≤48h、48h＜x≤120h、＞120h。判断标准：患者可在护士搀扶下床，可独立在床边走动≥5min且生命体征平稳，主诉无头晕头痛不适。 4.疼痛控制满意度：采用沈自制的疼痛控制情况调查表，评价术后患者疼痛控制满意度。包括3个条目；对控制或减轻疼痛方法的满意度、对控制疼痛的教育的满意度、总体满意度。采用采用Linkert 5级评分法, 1~5分分别表示“非常不满意”、“不满意”、“一般”、“满意”、“很满意”,，得分越高，疼痛控制效果越好，患者越满意。 

Description for medicine or protocol of treatment in detail：

1. postoperative pain degree of patients: the pain degree of patients from the first day to the fifth day after operation was evaluated by numerical rating system (NRS), with the second day after operation as the primary endpoint. 2. patient KAP questionnaire: by using the pain KAP questionnaire developed by Sun Jing [25] and others in 2014, this questionnaire has 36 items, including three sub questionnaires of pain knowledge, pain belief, and pain control behavior. For the patient pain knowledge questionnaire, in order to judge the question type, 1 point will be given for the correct answer of the forward question, no score for other questions, 1 point will be given for the wrong answer of the reverse question, and no score for other questions. The full score is 14 points. The higher the score, the better the cognitive level; There are 15 items in the patient's pain belief questionnaire. Using the linkert 5-level scoring method, 1-5 points indicate "strongly agree", "agree", "general", "disagree", "strongly disagree", respectively. The higher the score, the more positive the pain belief tends to be; The patient pain control behavior questionnaire has 7 items. The linkert 4-level scoring method is used for multiple-choice questions. 1-4 points indicate "never", "rarely", "often" and "always". The higher the score, the better the pain control behavior 3. time of the patient getting out of bed for the first time after surgery: record the specific time interval from the end of surgery to the first time of getting out of bed. The time period is divided into: within 24 hours, 24h ≤ x ≤ 48h, 48h < x ≤ 120h, > 120h. Judgment criteria: the patient can get out of bed with the help of the nurse, can walk independently at the bedside for ≥ 5min and have stable vital signs, and the chief complaint is no dizziness, headache or discomfort. 4. satisfaction with pain control: Shen's self-made pain control questionnaire was used to evaluate postoperative patients' satisfaction with pain control. Including 3 entries; Satisfaction with pain control or relief methods, satisfaction with pain control education, and overall satisfaction. The linkert 5-level scoring method is adopted, and 1-5 points respectively indicate "very dissatisfied", "dissatisfied", "general", "satisfied" and "very satisfied". The higher the score, the better the pain control effect, and the more satisfied the patient is. 

纳入标准：

以中山大学附属第一医院的心脏外科住院行开胸瓣膜置换患者研究对象，选取2024年12月-2025年5月份患者75例为对照组，2025年6-2025年12月份患者75例为实验组。入住患者均严格遵循本研究的纳排标准。2组患者在年龄、性别、手术名称、婚姻状况、文化程度等方面比较差异无统计学意义 (P>0.05) , 具有可比性。 纳入标准：①手术方式以正中胸骨切开心脏直术式瓣膜置换者②18≤年龄≤70岁③意识清醒，可沟通者④知情并同意本研究者。

Inclusion criteria

Taking the patients with open heart valve replacement in the First Affiliated Hospital of Sun Yat sen University as the research object, 75 patients from December 2024 to may 2025 were selected as the control group, and 75 patients from June 2025 to December 2025 were selected as the experimental group. The admission patients strictly followed the inclusion and discharge criteria of this study. There was no significant difference between the two groups in age, gender, operation name, marital status, education level and other aspects (p>0.05), Comparable. Inclusion criteria: 1. patients who underwent heart valve replacement by median sternotomy ;2. 18 <=age <= 70 years ;3.those who were conscious and communicable; 4. those who were informed and consented to the study

排除标准：

①合并有严重的肝肾功能不全者②认知障碍，无法沟通者。

Exclusion criteria：

1. Patients with severe hepatic and renal insufficiency ;2. cognitive impairment and inability to communicate

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从From 2024-12-10 00:00:00 至 To 2025-12-31 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

75

Group：

Intervention group

Sample size：

干预措施：

在对照组基础上接受基于格林模式的疼痛健康教育。主要研究者对科室医护人员小组对格林模式实施步骤方法及围手术期疼痛原因、预防、处理原则等相关知识进行反复强化培训，由运用格林模式对患者疼痛管理不当产生的倾向、促成、强化因素进行评估，采取问卷调查法了解患者对疼痛的了解程度，采用访谈法了解患者对术后疼痛的相关知识、治疗的态度、自我管理，由小组分析出3个因素，并针对其进行干预。

干预措施代码：

Intervention：

The patients in the control group received pain health education based on green model. The main researcher repeatedly strengthened the training on the implementation steps and methods of the green model and the perioperative pain causes, prevention, treatment principles and other related knowledge of the medical staff team in the Department. The green model was used to evaluate the tendency, contributing and strengthening factors of patients' improper pain management. The questionnaire survey method was used to understand the patients' understanding of pain. The interview method was used to understand the patients' relevant knowledge, treatment attitude and self-management of postoperative pain. The team analyzed three factors and intervened against them.

Intervention code：

组别：

对照组

样本量：

75

Group：

Control group

Sample size：

干预措施：

接受常规健康教育。包括入院的环境、饮食、疾病相关知识介绍。术前一天护士采取面对面的术前宣教，内容包括饮食要求、物品准备等。返回病房后介绍术后注意事项，如用药、管道、呼吸功能锻炼及运动指导，并给与相应的答疑和指导。

干预措施代码：

Intervention：

106/10000 Real time translation of document images 106/10000 to receive routine health education. Including an introduction to the environment, diet, and disease-related knowledge upon admission. The day before the surgery, the nurse conducted face-to-face preoperative education, including dietary requirements, item preparation, etc. After returning to the ward, introduce postoperative precautions such as medication, tubing, respiratory function exercise, and exercise guidance, and provide corresponding answers and guidance. Translate to receive routine health education Including the introduction of the environment, diet and disease-related knowledge of admission. The day before the operation, the nurse took face-to-face preoperative education, including dietary requirements, preparation of items, etc. After returning to the ward, introduce the postoperative precautions, such as medication, pipeline, respiratory function exercise and exercise guidance, and give corresponding answers and guidance. Receive routine health education. Including the introduction of the environment, diet and disease-related knowledge of admission. The day before the operation, the nurse took face-to-face preoperative education, including dietary requirements, preparation of items, etc. After returning to the ward, introduce the postoperative precautions, such as medication, pipeline, respiratory function exercise and exercise guidance, and give corresponding answers and guidance.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong Province 

City：

 

单位(医院)：

中山大学附属第一医院 

单位级别：

三级 

Institution
hospital：

The First Affiliated Hospital of Sun Yat sen University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

术后首次下床时间

指标类型：

次要指标

Outcome：

First time out of bed after surgery

Type：

Secondary indicator

测量时间点：

记录患者从手术结束到首次下床活动的具体时间间隔

测量方法：

患者可在护士搀扶下床，可独立在床边走动≥5min且生命体征平稳，主诉无头晕头痛不适。时间段分为：24小时内、24h≤x≤48h、48h＜x≤120h、＞120h。

Measure time point of outcome：

The specific time interval from the end of surgery to the first ambulation was recorded

Measure method：

The patient could get out of bed with the support of the nurse, walk around the bed independently for ≥5min, and the vital signs were stable, with no complaints of dizziness, headache and discomfort. The value can be within 24 hours, 24 hours ≤x≤48h, 48 hours < x≤120h, or 120h.

指标中文名：

手术第2日疼痛评分

指标类型：

主要指标

Outcome：

Pain score on day 2 of surgery

Type：

Primary indicator

测量时间点：

主诉疼痛时或者手术第2日晚上10点

测量方法：

NRS疼痛评估量表

Measure time point of outcome：

When the chief complained of pain or at 10:00 p.m. on the second day of surgery

Measure method：

NRS Pain Assessment Scale

指标中文名：

疼痛控制满意度

指标类型：

次要指标

Outcome：

Satisfaction with pain control

Type：

Secondary indicator

测量时间点：

出院前

测量方法：

采用沈自制的疼痛控制情况调查表，评价术后患者疼痛控制满意度。包括3个条目；对控制或减轻疼痛方法的满意度、对控制疼痛的教育的满意度、总体满意度。采用采用Linkert 5级评分法, 1~5分分别表示“非常不满意”、“不满意”、“一般”、“满意”、“很满意”,，得分越高，疼痛控制效果越好，患者越满意。

Measure time point of outcome：

Before discharge

Measure method：

Shen's pain control questionnaire was used to evaluate the satisfaction of postoperative patients with pain control. Includes 3 entries; Satisfaction with methods to control or reduce pain, satisfaction with education to control pain, and overall satisfaction. Linkert 5-level scoring method was adopted, with 1-5 points indicating "very dissatisfied", "dissatisfied", "general", "satisfied" and "very satisfied" respectively. The higher the score, the better the pain control effect and the more sat

指标中文名：

患者知信行问卷调查

指标类型：

主要指标

Outcome：

Patient knowledge and practice questionnaire

Type：

Primary indicator

测量时间点：

手术第14天

测量方法：

通过采用孙静等人在2014年研制《疼痛知信行调查问卷》，本问卷编制了36个条目, 包括疼痛知识、疼痛信念、疼痛控制行为三个子问卷。患者疼痛知识问卷, 为判断题型, 正向题答对得1分, 其它不得分, 反向题答错得1分, 其它不得分, 满分为14分, 得分越高表示认知程度越好;患者疼痛信念问卷共15个条目,采用Linkert 5级评分法, 1~5分分别表示“非常同意”、“同意”、“一般”、“不同意”、“非常不同意”, 得分越高, 表示疼痛信念越趋于正向;患者疼痛控制行为问卷共7个条目, 为选择题采用Linkert 4级评分法, 1~4分分别表示“从不”、“很少”、“经常”、“总是”, 得分越高表示疼痛控制行为越好

Measure time point of outcome：

Day 14 of surgery

Measure method：

By using the pain knowledge, attitude and practice questionnaire developed by Sun Jing [25] and others in 2014, this questionnaire has 36 items, including three sub questionnaires of pain knowledge, pain belief and pain control behavior. For the patient pain knowledge questionnaire, in order to judge the question type, 1 point will be given for the correct answer of the forward question, no score for other questions, 1 point will be given for the wrong answer of the reverse question, and no scor

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 70 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）：

无

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

None

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：

无

Blinding：

None

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）：

采用问卷星的方法，网址为https://www.wjx.cn/vm/h4bHtwZ.aspx

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

https://www.wjx.cn/vm/h4bHtwZ.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：

数据收集：包括患者的基本信息、疼痛评分（NRS评分）、疼痛知信行问卷、术后首次下床活动时间、疼痛控制满意度等。 收集方式：通过问卷星收集数据。 数据保存：为标准化的Excel、SPSS等，便于后续的数据管理。 质量管理：对收回的问卷逐一检查, 剔除无效问卷。问卷剔除的统一标准为:未按要求填写问卷或漏填项目的一律剔除。

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

Data collection: including patients' basic information, pain score (NRS score), pain knowledge, attitude and practice questionnaire, time of first ambulation after surgery, satisfaction with pain control, etc. Collection method: collect data through questionnaire star. Data storage: standardized excel, SPSS, etc., for subsequent data management. Quality management: check the returned questionnaires one by one and eliminate the invalid questionnaires. The unified standard for eliminating the questionnaire is: those who fail to fill in the questionnaire as required or fail to fill in the items will be eliminated.

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：

  2025-05-27 09:05:09