格林模式护理在妇科腹腔镜术后早期离床活动中的运用研究

注册号:

Registration number:

ChiCTR2500102594 

最近更新日期:

Date of Last Refreshed on:

2025-05-16 11:18:31 

注册时间:

Date of Registration:

2025-05-16 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

格林模式护理在妇科腹腔镜术后早期离床活动中的运用研究

Public title:

Research on the Application of Green Model Nursing in Early Bedding Activities after Gynecological Laparoscopic Surgery

注册题目简写:

English Acronym:

研究课题的正式科学名称:

格林模式护理在妇科腹腔镜术后早期离床活动中的运用研究

Scientific title:

Research on the Application of Green Model Nursing in Early Bedding Activities after Gynecological Laparoscopic 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:

王麒麟 

研究负责人:

王麒麟 

Applicant:

Wang Qilin 

Study leader:

Wang Qilin 

申请注册联系人电话:

Applicant telephone:

+86 182 8040 5211

研究负责人电话:

Study leader's
telephone:

+86 182 8040 5211

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:

18280405211@163.com

研究负责人电子邮件:

Study leader's E-mail:

18280405211@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:

成都市龙泉驿区董朗路669号

研究负责人通讯地址:

成都市龙泉驿区董朗路669号

Applicant address:

669 Donglang Road, Longquanyi District, Chengdu City

Study leader's address:

669 Donglang Road, Longquanyi District, Chengdu City

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:

成都市龙泉驿区第一人民医院

Applicant's institution:

The First People's Hospital of Longquanyi District, Chengdu

研究负责人所在单位:

成都市龙泉驿区第一人民医院

Affiliation of the Leader:

The First People's Hospital of Longquanyi District, Chengdu

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:

AF-KY-2023020

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:

成都市龙泉驿区第一人民医院医院伦理审查委员会

Name of the ethic committee:

Ethics Review Committee of the First People's Hospital of Longquanyi District, Chengdu City

伦理委员会批准日期:

Date of approved by ethic committee:

2023-06-21 00:00:00

伦理委员会联系人:

郑冬梅

Contact Name of the ethic committee:

Zheng Dongmei

伦理委员会联系地址:

成都市龙泉驿区董朗路669号

Contact Address of the ethic committee:

669 Donglang Road, Longquanyi District, Chengdu City

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 182 8017 2004

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:

成都市龙泉驿区第一人民医院

Primary sponsor:

The First People's Hospital of Longquanyi District, Chengdu

研究实施负责(组长)单位地址:

成都市龙泉驿区董朗路669号

Primary sponsor's address:

The First People's Hospital of Longquanyi District, Chengdu

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都市龙泉驿区第一人民医院

具体地址:

成都市龙泉驿区董朗路669号

Institution
hospital:

The First People's Hospital of Longquanyi District, Chengdu

Address:

669 Donglang Road, Longquanyi District, Chengdu City

经费或物资来源:

自筹

Source(s) of funding:

raise independently

研究疾病:

妇科腹腔镜手术患者  

Target disease:

Patients undergoing gynecological laparoscopic surgery

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:

探讨格林模式联合路径式健康教育这一联合的健康教育模式对盆腔良性肿物切除术患者早期下床活动有效执行与落实的效果,寻找更能有效推进我科加速康复、减少术后并发症的健康教育方法,追踪提高患者自理能力、增加患者舒适度、提高医护人员健康教育能力、提高患者满意度,促使护理质量得到持续改进。  

Objectives of Study:

Exploring the effectiveness of the Green model combined with pathway based health education in the early mobilization and implementation of patients undergoing pelvic benign tumor resection surgery, and seeking more effective health education methods to accelerate rehabilitation and reduce postoperative complications in our department. We aim to track and improve patients' self-care ability, increase patient comfort, enhance the health education ability of medical staff, improve patient satisfaction, and promote continuous improvement in nursing quality.

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.精神疾病、认知障碍、语言障碍、沟通障碍; 2.合并全身严重器质性疾病者; 3.不同意此次研究方案或未签署知情同意书者。

Exclusion criteria:

1. Mental illness, cognitive impairment, language barrier, communication barrier; 2.Patients with severe systemic organic diseases; 3.Those who do not agree with the research protocol or have not signed the informed consent form.

研究实施时间:

Study execute time:

From 2023-06-21 00:00:00 To 2024-06-19 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-08-24 00:00:00 To 2024-06-19 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

90

Group:

Experimental group

Sample size:

干预措施:

采取格林模式联合路径式健康教育模式进行健康宣教

干预措施代码:

01

Intervention:

Adopt the Green Model joint pathway health education model for health promotion

Intervention code:

组别:

对照组

样本量:

90

Group:

Control group

Sample size:

干预措施:

常规模式

干预措施代码:

02

Intervention:

Regular mode

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

四川 

市(区县):

成都 

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都市龙泉驿区第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu Longquanyi District People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

术后首次离床时间

指标类型:

主要指标

Outcome:

The first time out of bed after surgery

Type:

Primary indicator

测量时间点:

术后返回病房时间至首次下床时间

测量方法:

Measure time point of outcome:

Time from postoperative return to the ward to the first time getting out of bed

Measure method:

指标中文名:

术后首次肛门排气时间

指标类型:

主要指标

Outcome:

Time of first flatus after surgery

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后肩背疼痛发生情况

指标类型:

主要指标

Outcome:

Postoperative shoulder and back pain occurrence

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹胀发生率

指标类型:

附加指标

Outcome:

Postoperative abdominal distension rate

Type:

Additional 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:

血液

组织:

Sample Name:

Blood

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

Table of random numbers

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

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):

研究结束后6个月,以邮件的形式联系研究者

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

Contact the researchers by email 6 months after the end of the study.

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:

CRF

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-05-16 11:18:23