中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600121304
最近更新日期： Date of Last Refreshed on：	2026-03-29 18:36:35
注册时间： Date of Registration：	2026-03-27 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	基于信息-知识-信念-行为(IKAP)模式的护理干预在肺炎支原体(MP)感染患儿住院管理中的应用研究
Public title：	Application of nursing intervention based on information-knowledge-belief-behavior (IKAP) model in hospital management of children infected with mycoplasma pneumoniae (MP)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于信息-知识-信念-行为(IKAP)模式的护理干预在肺炎支原体(MP)感染患儿住院管理中的应用研究
Scientific title：	Application of nursing intervention based on information-knowledge-belief-behavior (IKAP) model in hospital management of children infected with mycoplasma pneumoniae (MP)
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：	马瑞	研究负责人：	张月霞
Applicant：	Ma Rui	Study leader：	Zhang Yuexia
申请注册联系人电话： Applicant telephone：	+86 150 9535 7739	研究负责人电话： Study leader's telephone：	+86 139 0946 7979
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：	marui5744@126.com	研究负责人电子邮件： Study leader's E-mail：	zyx7980@163.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：	甘肃省兰州市城关区南滨河东路5666号	研究负责人通讯地址：	甘肃省兰州市城关区南滨河东路5666号
Applicant address：	5666 Nanbinhe East Road, Chengguan District, Lanzhou City, Gansu Province	Study leader's address：	5666 Nanbinhe East Road, Chengguan District, Lanzhou City, Gansu 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：	兰州市妇幼保健院
Applicant's institution：	Lanzhou Maternal and Child Health Hospital
研究负责人所在单位：	兰州市妇幼保健院
Affiliation of the Leader：	Lanzhou Maternal and Child Health 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：	20240008	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：	兰州市妇幼保健院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Lanzhou Maternal and Child Health Care Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-08-01 00:00:00
伦理委员会联系人：	赵云
Contact Name of the ethic committee：	Zhao Yun
伦理委员会联系地址：	甘肃省兰州市城关区南滨河东路5666号
Contact Address of the ethic committee：	5666 Nanbinhe East Road, Chengguan District, Lanzhou City, Gansu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 180 8931 7705	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：

兰州市妇幼保健院

Primary sponsor：

Lanzhou Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

甘肃省兰州市城关区南滨河东路5666号

Primary sponsor's address：

5666 Nanbinhe East Road, Chengguan District, Lanzhou City, Gansu 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)：	甘肃	市(区县)：
Country：	China	Province：	Gansu	City：
单位(医院)：	兰州市妇幼保健院	具体地址：	甘肃省兰州市城关区南滨河东路5666号
Institution hospital：	Lanzhou Maternal and Child Health Hospital	Address：	5666 Nanbinhe East Road, Chengguan District, Lanzhou City, Gansu Province

经费或物资来源：

项目基金

Source(s) of funding：

Project Grant

研究疾病：

儿科肺炎支原体肺炎

Target disease：

Pediatric Mycoplasma Pneumoniae Pneumonia

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：

探讨基于信息-知识-态度-实践（IKAP）模型的个体化护理对肺炎支原体感染住院患儿预后的影响

Objectives of Study：

To explore the influence of individualized nursing based on information-knowledge-attitude-practice (IKAP) model on the prognosis of hospitalized children with mycoplasma pneumoniae infection.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

符合以下任一标准的儿童将被排除：①有严重神经精神障碍病史，如精神疾病或认知障碍；②儿童或主要照护者因语言或认知障碍导致无法有效沟通，致使无法完成随访及问卷评估；③同时参与可能影响住院治疗结果的其他临床研究或护理干预；④因转院、自行出院或其他原因导致无法完成干预或结局评估，从而产生大量缺失数据。

Exclusion criteria：

Children meeting any of the following criteria will be excluded: 1. A history of severe neuropsychiatric disorders, such as mental illness or cognitive impairment; 2. The child or the primary caregiver has language or cognitive impairments that prevent effective communication, making it impossible to complete follow-up and questionnaire assessments; 3. Participation in other clinical studies or care interventions that may affect the outcome of hospitalization; 4. Transfer to another hospital, self-discharge, or other reasons that prevent the completion of the intervention or outcome assessment, resulting in a large amount of missing data.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2026-10-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-07-01 00:00:00 至 To 2026-10-01 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	100
Group：	Control Group	Sample size：	100
干预措施：	在研究启动前，参与试验的儿科医师、初级护士和研究助理均接受了标准化培训。培训内容包括纳入与排除标准、随机化流程、常规护理路径、 IKAP 护理模式，以及结局指标的定义与记录规范，以确保干预措施实施的一致性。对照组（常规护理）：住院期间，对照组患儿接受医院标准的儿科呼吸专科护理，主要包括： (1) 一般状况及生命体征的入院评估，并按医嘱完成血液检测、影像学检查及微生物学检查； (2) 按医嘱实施抗感染治疗、雾化吸入、氧疗及对症处理（退热药、镇咳药和祛痰药），并密切监测临床状态的任何异常变化并记录； (3) 向监护人提供关于受监护环境、医院规章制度及基本安全注意事项的信息，并解答有关用药、诊断程序及疾病进展的问题； (4) 在患儿病情稳定后实施基础健康教育，内容包括合理用药、保持气道通畅、休息指导及饮食建议； (5) 当符合出院标准时协助办理出院手续，并口头告知监护人随访安排及关键注意事项； (6) 按照科室常规操作规范，通过电话或门诊随访进行出院后随访。	干预措施代码：
Intervention：	Before study initiation, pediatricians, primary nurses, and research assistants participating in the trial received standardized training. The training covered the inclusion and exclusion criteria, randomization procedures, usual care pathways, the IKAP nursing model, and the definitions and recording protocols for outcome measures, to ensure consistency in intervention delivery. Control group (usual care): During hospitalization, children in the control group received the hospital’s standard pediatric respiratory specialist nursing care, which mainly included: (1) admission assessment of general condition and vital signs, and completion of blood tests, imaging, and microbiological examinations as ordered; (2) administration of anti-infective therapy, nebulization, oxygen therapy, and symptomatic treatment (antipyretics, antitussives, and expectorants) according to medical orders, with close monitoring and documentation of any abnormal changes in clinical status; (3) providing guardians with information about the ward environment, hospital regulations, and basic safety precautions, and addressing questions regarding medication use, diagnostic procedures, and disease progression; (4) delivering general health education once the child’s condition had stabilized, including appropriate medication use, maintenance of airway patency, rest, and dietary advice; (5) assisting with discharge procedures when discharge criteria were met, and verbally informing guardians of follow-up schedules and key precautions; (6) conducting post-discharge follow-up by telephone or outpatient visits according to routine departmental practice.	Intervention code：

组别：	干预组	样本量：	100
Group：	Intervention Group	Sample size：	100
干预措施：	干预组（常规护理+ IKAP 干预）：干预组儿童接受与上述相同的常规护理。此外，经过培训的专科护士为患儿及其主要照护者提供基于 IKAP 的个体化护理，主要包括两个方面： (1) IKAP 护理团队的组建：组建了 IKAP 护理团队，成员包括儿科呼吸专科医师、初级儿科护士、资深专科护士、心理健康/健康教育护士以及负责营养与康复指导的工作人员。所有成员均具备相应专业资质，经过统一培训后，根据其专业特长被分配具体职责。住院期间，团队协同开展患儿及照护者的信息评估、健康教育和行为指导工作。 (2) IKAP 护理的实施：在常规护理基础上，围绕四个核心要素——信息收集、知识教育、信念支持和行为指导——实施结构化个体化护理措施。入院24小时内，由初级护士完成初步信息评估，内容包括患儿年龄、疾病严重程度、呼吸系统疾病史、家庭照护能力及照护者健康素养。基于评估结果，以分层分阶段方式提供疾病相关教育（如MP感染特征、药物治疗要点、雾化与氧疗注意事项及并发症早期预警信号）。通过示范教学、情景模拟沟通及问答互动，护士致力于提升照护者对治疗方案的理解与信任，缓解其焦虑与无助感。根据患儿病情变化，指导照护者在住院期间及出院后采取特定照护行为，如保持正确体位、配合雾化治疗与呼吸训练、加强环境与饮食管理。出院前，照护者接受结构化出院准备教育，内容包括居家观察要点、随访安排及再次就医指征。必要时提供额外咨询渠道（如通过微信）。	干预措施代码：
Intervention：	Intervention group (usual care + IKAP intervention): Children in the intervention group received the same usual care as above. In addition, trained specialist nurses provided individualized IKAP-based nursing for the child and primary caregiver, consisting of two main components: (1) Establishment of an IKAP nursing team: An IKAP care team was formed, comprising pediatric respiratory specialists, primary pediatric nurses, senior specialist nurses, mental health/health education nurses, and staff responsible for nutrition and rehabilitation guidance. All members held appropriate professional qualifications and, after unified training, were assigned specific roles according to their expertise. During hospitalization, the team collaboratively conducted information assessment, health education, and behavioral guidance for children and caregivers. (2) Implementation of IKAP-based nursing: On top of usual care, structured and individualized nursing measures were delivered around four components — information collection, knowledge education, belief support, and behavioral guidance. Within 24 hours of admission, the primary nurse performed an initial information assessment, including the child’s age, disease severity, history of respiratory disease, family caregiving capacity, and the caregiver’s health literacy. Based on this assessment, disease-related education was provided in a stratified and staged manner (e.g., characteristics of MP infection, key points of pharmacotherapy, precautions for nebulization and oxygen therapy, and early warning signs of complications). Through demonstrations, scenario-based communication, and question-and-answer interactions, nurses sought to improve caregivers’ understanding and trust in the treatment plan and alleviate anxiety and helplessness. In line with changes in the child’s condition, caregivers were guided in specific caregiving behaviors during hospitalization and after discharge, such as maintaining appropriate positioning, cooperating with nebulization and respiratory exercises, and strengthening environmental and dietary management. Before discharge, caregivers received structured discharge preparation education, including home observation points, follow-up arrangements, and indications for seeking medical attention again. When necessary, additional counseling channels (e.g., via WeChat) were offered.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	甘肃省	市(区县)：
Country：	China	Province：	Gansu	City：
单位(医院)：	兰州市妇幼保健院	单位级别：	三级
Institution hospital：	Lanzhou Maternal and Child Health Hospital	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	住院天数	指标类型：	主要指标
Outcome：	Length of hospital stay	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	医疗总费用	指标类型：	主要指标
Outcome：	Total medical expenses	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	家属满意度	指标类型：	主要指标
Outcome：	Family satisfaction	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	年龄	指标类型：	次要指标
Outcome：	Age	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	性别	指标类型：	次要指标
Outcome：	Gender	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	入院诊断	指标类型：	次要指标
Outcome：	Admission Diagnosis	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	症状数量	指标类型：	次要指标
Outcome：	Number of Symptoms	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	医保统筹费用	指标类型：	次要指标
Outcome：	Medical Insurance Pooling Expenses	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	自筹费用	指标类型：	次要指标
Outcome：	Self-Paid Expenses	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	30天再入院	指标类型：	次要指标
Outcome：	30-Day Readmission	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	0	岁 years
最大 Max age	13	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）：

在研究启动前，所有参与的医护人员均接受了关于纳入与排除标准、干预流程及数据收集方案的标准化培训。随机分组由未参与临床护理或结局评估的研究人员执行。具体而言，所有符合入选标准且签署书面知情同意书的住院MP感染患儿，均按入院顺序分配连续识别编号。随后采用随机数字表进行1:1比例分组。从表中任意条目开始，按从左至右顺序读取随机数字。对于每个获得的随机数字，取其模2余数：若余数为0，则将对应患儿分配至对照组；若余数为1，则分配至 IKAP 组。该过程重复进行直至所有入组患儿完成分组。为最大限度减少组间污染，患者被安置在病房两端的房间内，同一房间内的所有儿童均属于同一研究组，从而在常规护理和健康教育过程中降低交叉暴露风险。

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

Before study initiation, all participating medical and nursing staff received standardized training on the inclusion and exclusion criteria, intervention procedures, and data collection protocols. Randomization was conducted by research personnel who were not involved in clinical care or outcome assessment. Specifically, all hospitalized children with MP infection who met the eligibility criteria and provided written informed consent were assigned a serial identification number according to their order of admission. Group allocation then followed a 1:1 ratio using a random-number table. Starting from an arbitrary entry in the table, random numbers were read sequentially from left to right. For each random number obtained, the number was taken modulo 2: if the remainder was 0, the corresponding child was allocated to the control group; if the remainder was 1, the child was allocated to the IKAP group. This process was repeated until all enrolled children had been assigned. To minimize contamination between groups, patients were placed in rooms located at opposite ends of the ward, and all children within the same room belonged to the same study group, thereby reducing cross-exposure during routine nursing care and health education.

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：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	预计2028年12月在临床试验公共管理平台公开原始数据，网址：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)：	It is expected that the raw data will be publicly available on the public administration platform for clinical trials in December 2028. Website: 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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-03-27 17:37:54