中国住院患者对纳米医学的态度:一项多中心、横断面临床研究

注册号:

Registration number:

ChiCTR2500109481 

最近更新日期:

Date of Last Refreshed on:

2025-09-19 08:30:35 

注册时间:

Date of Registration:

2025-09-19 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

中国住院患者对纳米医学的态度:一项多中心、横断面临床研究

Public title:

Attitudes Toward Nanomedicine Among Hospitalized Patients in China: A Multicenter Cross-Sectional Clinical Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中国住院患者对纳米医学的态度:一项多中心、横断面临床研究

Scientific title:

Attitudes Toward Nanomedicine Among Hospitalized Patients in China: A Multicenter Cross-Sectional Clinical Study

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:

詹泽江 

研究负责人:

尹海燕 

Applicant:

Ze-Jiang Zhan 

Study leader:

Haiyan Yin 

申请注册联系人电话:

Applicant telephone:

+86 13268101204

研究负责人电话:

Study leader's
telephone:

+86 13318831222

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:

zhanzj@jnu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

haiyanyin1867@126.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:

广州市黄埔大道西613号,广州市天河区车陂北街22号之一,广州市中山大道中245号

研究负责人通讯地址:

广州市黄埔大道西613号,广州市天河区车陂北街22号之一,广州市中山大道中245号

Applicant address:

No. 613, Huangpu Avenue West, Guangzhou, No. 22-1, Chebei North Street, Tianhe District, Guangzhou, No. 245, Zhongshan Avenue Middle, Guangzhou

Study leader's address:

No. 613, Huangpu Avenue West, Guangzhou, No. 22-1, Chebei North Street, Tianhe District, Guangzhou, No. 245, Zhongshan Avenue Middle, Guangzhou

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:

暨南大学附属第一医院

Applicant's institution:

The First Affiliated Hospital of Jinan University

研究负责人所在单位:

暨南大学附属第一医院(广州华侨医院)

Affiliation of the Leader:

The First Affiliated Hospital, Jinan University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

KY-2025-157;KY-2025-210

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:

暨南大学附属第一医院涉人的科学研究伦理审查委员会

Name of the ethic committee:

Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-06-25 00:00:00

伦理委员会联系人:

黄瑶

Contact Name of the ethic committee:

Huang Yao

伦理委员会联系地址:

广州市黄埔大道西613号,广州市天河区车陂北街22号之一,广州市中山大道中245号

Contact Address of the ethic committee:

No. 613, Huangpu Avenue West, Guangzhou, No. 22-1, Chebei North Street, Tianhe District, Guangzhou, No. 245, Zhongshan Avenue Middle, Guangzhou

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 38688217

伦理委员会联系人邮箱:

Contact email of the ethic committee:

1522479395@qq.com

研究实施负责(组长)单位:

暨南大学附属第一医院(广州华侨医院)

Primary sponsor:

The First Affiliated Hospital, Jinan University

研究实施负责(组长)单位地址:

广州市黄埔大道西613号,广州市天河区车陂北街22号之一,广州市中山大道中245号

Primary sponsor's address:

No. 613, Huangpu Avenue West, Guangzhou, No. 22-1, Chebei North Street, Tianhe District, Guangzhou, No. 245, Zhongshan Avenue Middle, Guangzhou

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):

Country:

China

Province:

Guangdong

City:

单位(医院):

暨南大学附属第一医院(广州华侨医院)

具体地址:

广州市黄埔大道西613号,广州市天河区车陂北街22号之一,广州市中山大道中245号

Institution
hospital:

The First Affiliated Hospital, Jinan University

Address:

No. 613, Huangpu Avenue West, Guangzhou, No. 22-1, Chebei North Street, Tianhe District, Guangzhou, No. 245, Zhongshan Avenue Middle, Guangzhou

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-selected topic (self-funded)

研究疾病:

无  

Target disease:

None

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

评价中国住院患者对纳米医学的重要性认识、接受度、临床担忧以及对纳米医学研究的支持度,为纳米医学的临床实践提供思路指导。  

Objectives of Study:

To assess hospitalized patients’ perceptions of the importance of nanomedicine, their acceptance, clinical concerns, and level of support for nanomedicine research, in order to inform the future clinical implementation of nanomedicine in China.

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:

1.既往患精神类疾病且未治愈者;
2.有残疾或认知障碍;
3.参与其他类似的研究项目;
4.不愿合作者;

Exclusion criteria:

1.History of psychiatric disorders that remain unresolved;
2.Presence of disabilities or cognitive impairments;
3.Participation in other similar research studies;
4.Unwilling to cooperate;

研究实施时间:

Study execute time:

From 2025-10-01 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-10-01 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

对纳米医学的态度

样本量:

2477

Group:

Attitudes toward nanomedicine

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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

City:

单位(医院):

暨南大学附属第一医院(广州华侨医院) 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Jinan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广东医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Guangdong Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

珠海市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhuhai People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College, Guangzhou University of Traditional Chinese Medicine)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

吉林省 

市(区县):

 

Country:

China

Province:

Jilin

City:

单位(医院):

吉林大学中日联谊医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Union Hospital of Jilin University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

暨南大学附属第一医院(广州华侨医院) 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Jinan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The 2nd Affiliated Hospital of Chongqing Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属涪陵医院 

单位级别:

三级甲等 

Institution
hospital:

Chongqing University FuLing Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省 

市(区县):

 

Country:

China

Province:

Shanxi

City:

单位(医院):

山西医科大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The first hospital of Shanxi Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省 

市(区县):

 

Country:

China

Province:

Shanxi

City:

单位(医院):

山西省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Provincial People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省 

市(区县):

 

Country:

China

Province:

Shanxi

City:

单位(医院):

山西省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Provincel Cancer Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

普宁市人民医院 

单位级别:

三级甲等 

Institution
hospital:

PuNing Renming Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital,Sun Yat-sen University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

揭阳市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Jieyang People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市第五人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Fifth People Hospital of Chongqing

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

海南省 

市(区县):

 

Country:

China

Province:

Hainan

City:

单位(医院):

广东省中医院海南医院 

单位级别:

三级甲等 

Institution
hospital:

Hainan Hospital, Guangdong Provincial Hospital of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市急救医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Chongqing Emergency Medical Center

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

南方医科大学皮肤病医院(广东省皮肤病医院) 

单位级别:

三级甲等 

Institution
hospital:

Dematology Hospital of Southern Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市沙坪坝区人民医院 

单位级别:

三级医院 

Institution
hospital:

Shapingba District People's Hospital of Chongqing

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广州医科大学附属妇女儿童医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou Women and Children's Medical Center,Guangzhou Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

山东第一医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Shandong First Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Chongqing University Cancer Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属三峡医院(重庆三峡中心医院) 

单位级别:

三级甲等 

Institution
hospital:

Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省 

市(区县):

 

Country:

China

Province:

Shanxi

City:

单位(医院):

临汾市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Linfen Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省第二人民医院(广东省卫生应急医院) 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市黔江中心医院 

单位级别:

三级甲等 

Institution
hospital:

Qianjiang Central of Chongqing

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市江津区中心医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangjin Central Hospital of Chongqing

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

对纳米医学重要性的认识度

指标类型:

主要指标

Outcome:

Awareness of the importance of nanomedicine

Type:

Primary indicator

测量时间点:

住院期间

测量方法:

采用李克特五级量表衡量个体对纳米医学重要性的认识度。受访者根据自身感受在五个等级上作答,通常包括“非常不同意”“不同意”“一般”“同意”“非常同意”。该量表通过将主观态度数值化,便于统计分析和跨样本比较。

Measure time point of outcome:

during hospitalization

Measure method:

The 5-point Likert scale is used to measure individuals’ awareness of the importance of nanomedicine toward specific statements. Respondents rate their agreement on a five-level scale, typically including “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.” This scale quantifies subjective attitudes into numerical values, facilitating statistical analysis and cross-sample comparisons.

指标中文名:

对纳米医学的接受度

指标类型:

主要指标

Outcome:

Acceptance of Nanomedicine

Type:

Primary indicator

测量时间点:

住院期间

测量方法:

采用李克特五级量表衡量个体对纳米医学的接受度。受访者根据自身感受在五个等级上作答,通常包括“非常不同意”“不同意”“一般”“同意”“非常同意”。该量表通过将主观态度数值化,便于统计分析和跨样本比较。

Measure time point of outcome:

during hospitalization

Measure method:

The 5-point Likert scale is used to measure individuals’ acceptance of nanomedicine toward specific statements. Respondents rate their agreement on a five-level scale, typically including “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.” This scale quantifies subjective attitudes into numerical values, facilitating statistical analysis and cross-sample comparisons.

指标中文名:

对纳米医学的临床担忧

指标类型:

主要指标

Outcome:

Clinical Concerns Regarding Nanomedicine

Type:

Primary indicator

测量时间点:

住院期间

测量方法:

采用李克特五级量表衡量个体对纳米医学的临床担忧。受访者根据自身感受在五个等级上作答,通常包括“非常不同意”“不同意”“一般”“同意”“非常同意”。该量表通过将主观态度数值化,便于统计分析和跨样本比较。

Measure time point of outcome:

during hospitalization

Measure method:

The 5-point Likert scale is used to measure individuals’ clinical concerns regarding nanomedicine toward specific statements. Respondents rate their agreement on a five-level scale, typically including “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.” This scale quantifies subjective attitudes into numerical values, facilitating statistical analysis and cross-sample comparisons.

指标中文名:

对纳米医学研究的支持度

指标类型:

主要指标

Outcome:

Support for Nanomedicine Research

Type:

Primary indicator

测量时间点:

住院期间

测量方法:

采用李克特五级量表衡量个体对纳米医学研究的支持度。受访者根据自身感受在五个等级上作答,通常包括“非常不同意”“不同意”“一般”“同意”“非常同意”。该量表通过将主观态度数值化,便于统计分析和跨样本比较。

Measure time point of outcome:

during hospitalization

Measure method:

The 5-point Likert scale is used to measure individuals’ support for nanomedicine research toward specific statements. Respondents rate their agreement on a five-level scale, typically including “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.” This scale quantifies subjective attitudes into numerical values, facilitating statistical analysis and cross-sample comparisons.

指标中文名:

医疗卫生知识认知情况

指标类型:

次要指标

Outcome:

Awareness and Understanding of Medical and Health Knowledge

Type:

Secondary indicator

测量时间点:

住院期间

测量方法:

1. HLS-SF12 用于临床实践中衡量填表者对卫生健康知识的掌握度,是一种经过充分验证的涉及 12 项题目的量表,综合每项题目的回答最终计算填表者对卫生健康知识的掌握度。 2. 媒体使用情况量表(社交媒体使用强度问卷) 该量表包括 6 个项目(社会交流、自我展示、社会行动、休闲和娱乐、通过媒体获取信息和商业交易)。

Measure time point of outcome:

during hospitalization

Measure method:

1. HLS-SF12 The 12-item Short-Form Health Literacy Questionnaire (HLS-SF12) is a validated tool used in clinical practice to assess respondents’ health literacy. The overall score is calculated based on responses to 12 items and reflects the individual’s ability to understand and apply health-related information. 2. Media Use Scale (Social Media use within medical education) This scale includes six items covering different aspects of media use: social interaction, self-presentation, social activ

指标中文名:

生活质量评分

指标类型:

次要指标

Outcome:

Quality of Life Score

Type:

Secondary indicator

测量时间点:

住院期间

测量方法:

EQ-5D-5L 包含一个由五个健康维度组成的描述系统,包括行动能力、自我照顾、日常活动、疼痛或不舒服、焦虑或沮丧

Measure time point of outcome:

during hospitalization

Measure method:

The European Quality of Life 5-Dimension 5-Level version (EQ-5D-5L) includes a descriptive system consisting of five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

指标中文名:

简要疾病感知情况

指标类型:

次要指标

Outcome:

Brief Illness Perception

Type:

Secondary indicator

测量时间点:

住院期间

测量方法:

BIPQ 的全称为疾病感知问卷简化版量表,该量表根据 9 个问题评估了患者对自己疾病的感知[16]。问卷主要分为认知状态(第 1-5 项)、情绪状态(第 6、7 项)、理解(第 8 项)和因果感知(第 9 项)。

Measure time point of outcome:

during hospitalization

Measure method:

is a simplified tool designed to assess patients’ perceptions of their illness through nine items. The questionnaire is structured into four components: cognitive representation (Items 1–5), emotional representation (Items 6 and 7), illness comprehension (Item 8), and causal attribution (Item 9).

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NA

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 years
最大 Max age 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):

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:

Blinding:

None

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):

原始数据不会公开

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

The original data will not be made publicly available.

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:

每个患者的各项资料除了保存在问卷星平台,还应记录在 CRF 表上。为控制不同研究中心的问卷收集质量并减少因为医患双方对问卷信息的理解等存在的偏倚,统一对各中心的主要研究者和调查者(获得 GCP 证书)进行培训,确保问卷收集过程、对问卷中每一条目的理解的均一化。为确保患者对问卷中题目的正确理解和作答,问卷调查者与受访者需面对面进行,以便充分沟通和交流。

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

Patient data will be recorded both on the Wenjuanxing platform and in Case Report Forms (CRFs). To ensure consistent questionnaire quality and reduce bias from varying interpretations by investigators and patients, principal investigators and surveyors at each center (all GCP-certified) will undergo standardized training. Questionnaires will be administered face-to-face to ensure patients correctly understand and accurately respond to each item.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2025-09-19 08:29:29