ChiCTR2600126721 版本V1.0 版本创建时间2026/06/15 09:52:39 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:

ChiCTR2600126721 

最近更新日期:

Date of Last Refreshed on:

2026-06-15 09:52:24 

注册时间:

Date of Registration:

2026-06-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

全明格局ICU对医护人员职业倦怠的影响

Public title:

The impact of fully illuminated ICU layout on burnout among healthcare workers

注册题目简写:

English Acronym:

研究课题的正式科学名称:

全明格局ICU对医护人员职业倦怠的影响

Scientific title:

The impact of fully illuminated ICU layout on burnout among healthcare workers

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:

周晓 

研究负责人:

周晓 

Applicant:

Xiao Zhou 

Study leader:

Xiao Zhou 

申请注册联系人电话:

Applicant telephone:

+86 10 8083 8814

研究负责人电话:

Study leader's telephone:

+86 10 63138814

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:

nj20zx@163.com

研究负责人电子邮件:

Study leader's E-mail:

nj20zx@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:

中国北京市西城区永安路95号

研究负责人通讯地址:

中国北京市西城区永安路95号

Applicant address:

No. 95, Yong'an Road, Xicheng District, Beijing, China

Study leader's address:

No. 95, Yong'an Road, Xicheng District, Beijing, China

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:

首都医科大学附属北京友谊医院

Applicant's institution:

Beijing Friendship Hospital Affiliated to Capital Medical University

研究负责人所在单位:

首都医科大学附属北京友谊医院

Affiliation of the Leader:

Beijing Friendship Hospital ,Capital Medical 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:

2026-P2-293-01

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:

首都医科大学附属北京友谊医院生命伦理委员会

Name of the ethic committee:

Bioethics Committee, Beijing Friendship Hospital, Capital Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-05-20 00:00:00

伦理委员会联系人:

李悦

Contact Name of the ethic committee:

Li Yue

伦理委员会联系地址:

中国北京市西城区永安路95号

Contact Address of the ethic committee:

No. 95, Yong'an Road, Xicheng District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 63139006

伦理委员会联系人邮箱:

Contact email of the ethic committee:

13661202501@163.com

研究实施负责(组长)单位:

首都医科大学附属北京友谊医院

Primary sponsor:

Beijing Friendship Hospital ,Capital Medical University

研究实施负责(组长)单位地址:

中国北京市西城区永安路95号

Primary sponsor's address:

No. 95, Yong'an Road, Xicheng District, Beijing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院

具体地址:

中国北京市西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital ,Capital Medical University

Address:

No. 95, Yong'an Road, Xicheng District, Beijing, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

Target disease:

Bunrout

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:

在ICU职业倦怠问题突出、人文执业需求提升的背景下,深入探讨全明格局ICU对医护人员职业倦怠的影响,具有重要理论与实践意义。本文基于环境心理学与重症医学理论,分析全明格局在缓解压力、降低职业倦怠中的作用,为优化ICU建设、改善执业环境、构建科学干预策略提供依据,从而提升医疗质量,促进学科可持续发展。  

Objectives of Study:

Against the backdrop of prominent job burnout in the ICU and an increasing demand for humanistic clinical practice, a thorough investigation into the impact of a fully illuminated ICU layout on healthcare workers’ job burnout holds significant theoretical and practical value. Drawing on theories from environmental psychology and critical care medicine, this paper analyzes the role of the fully illuminated layout in alleviating stress and reducing burnout, thereby providing a basis for optimizing ICU design, improving the work environment, and developing scientific intervention strategies. Ultimately, this contributes to enhancing healthcare quality and promoting the sustainable development of the discipline.

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.北京某三甲医院综合ICU执业工作≥6个月的医生、护士;

Inclusion criteria

1.Doctors and nurses who have worked for >=6 months in the general ICU of a tertiary hospital in Beijing.

排除标准:

进修、轮转人员及近期发生重大负性生活事件者。

Exclusion criteria:

Those who are on further education or rotation programs, as well as those who have recently experienced significant negative life events.

研究实施时间:

Study execute time:

From 2026-05-01 00:00:00 To 2027-05-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-15 00:00:00 To 2026-06-30 00:00:00  

干预措施:

Interventions:

组别:

传统格局ICU组

样本量:

120

Group:

Traditional layout group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

全明格局组

样本量:

120

Group:

Full-light group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital ,Capital Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

个人成就感

指标类型:

主要指标

Outcome:

Personal Accomplishment

Type:

Primary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

指标中文名:

感知压力量表

指标类型:

主要指标

Outcome:

Perceived Stress Scale

Type:

Primary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index

Type:

Secondary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

指标中文名:

去人格化

指标类型:

主要指标

Outcome:

Depersonalization

Type:

Primary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

指标中文名:

ICU 光环境与空间舒适度自评量表

指标类型:

次要指标

Outcome:

Self-Rated Scale of Light Environment and Spatial Comfort in the ICU

Type:

Secondary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

指标中文名:

情绪衰竭

指标类型:

主要指标

Outcome:

Emotional Exhaustion

Type:

Primary indicator

测量时间点:

入组即刻

测量方法:

问卷调查获得

Measure time point of outcome:

At the time of enrollment

Measure method:

Acquired via questionnaires

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

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 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

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):

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:

应用电子调查问卷收集信息,导出为病历记录表,应用SPSS26.0进行电子数据采集和管理。

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

Electronic questionnaires were used to collect information, which was exported as a medical record form. SPSS 26.0 was applied for electronic data collection and management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-06-15 09:52:24