简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Effects of a nurse-led stress management and resilience training programme: A randomised wait-list controlled trial
下载XML文档

注册号：

Registration number：

 ChiCTR2400092712 

最近更新日期：

Date of Last Refreshed on：

 2024-11-21 16:30:20 

注册时间：

Date of Registration：

 2024-11-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of a nurse-led stress management and resilience training programme: A randomised wait-list controlled trial

Public title：

Effects of a nurse-led stress management and resilience training programme: A randomised wait-list controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effects of a nurse-led stress management and resilience training programme: A randomised wait-list controlled trial

Scientific title：

Effects of a nurse-led stress management and resilience training programme: A randomised wait-list controlled trial

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：

Wong Sze Wing Julia 

研究负责人：

Wong Sze Wing Julia 

Applicant：

Wong Sze Wing Julia 

Study leader：

Wong Sze Wing Julia 

申请注册联系人电话：

Applicant telephone：

 +852 9100 2535

研究负责人电话：

Study leader's
telephone：

+852 9100 2535

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：

 juliawong@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 juliawong@twc.edu.hk

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：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

研究负责人通讯地址：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

Applicant address：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

Study leader's address：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

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：

Tung Wah College

Applicant's institution：

Tung Wah College

研究负责人所在单位：

Tung Wah College

Affiliation of the Leader：

Tung Wah College

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：

 REC2024195

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：

Research Ethics Committee, Tung Wah College

Name of the ethic committee：

Research Ethics Committee, Tung Wah College

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-13 00:00:00

伦理委员会联系人：

Lorna SUEN

Contact Name of the ethic committee：

Lorna SUEN

伦理委员会联系地址：

Tung Wah College, 31 Wylie Road, Homantin, Hong Kong

Contact Address of the ethic committee：

Tung Wah College, 31 Wylie Road, Homantin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3190 6686

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ro@twc.edu.hk

研究实施负责（组长）单位：

Tung Wah College

Primary sponsor：

Tung Wah College

研究实施负责（组长）单位地址：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

Primary sponsor's address：

16/F, School of Nursing, Tung Wah College, 31 Wylie Road, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

University Grants Committee

具体地址：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong

Institution
hospital：

University Grants Committee

Address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong

经费或物资来源：

Faculty Development Scheme

Source(s) of funding：

Faculty Development Scheme

研究疾病：

None  

Target disease：

None

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. Examine the change in the nursing undergraduates’ resilience level across four time points after they have completed the SMART programme. 2. Examine changes in the nursing undergraduates’ stress, anxiety, and depression levels across four time points after they have completed the SMART programme.  

Objectives of Study：

1. Examine the change in the nursing undergraduates’ resilience level across four time points after they have completed the SMART programme. 2. Examine changes in the nursing undergraduates’ stress, anxiety, and depression levels across four time points after they have completed the SMART programme.

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：

Those who are undergoing psychiatric treatment or have participated in other studies or programmes related to psychosocial support will be excluded from the data analysis because their data may contaminate the results.

Exclusion criteria：

Those who are undergoing psychiatric treatment or have participated in other studies or programmes related to psychosocial support will be excluded from the data analysis because their data may contaminate the results.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2025-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-01 00:00:00 至 To 2025-04-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 200

Group：

Intervention group

Sample size：

干预措施：

Stress management and resilience training programme with three 2.5-hour face-to-face training sessions every two weeks will be added into the pre-clinical practicum training

干预措施代码：

Intervention：

Stress management and resilience training programme with three 2.5-hour face-to-face training sessions every two weeks will be added into the pre-clinical practicum training

Intervention code：

组别：

Wait-list control group

样本量：

 200

Group：

Wait-list control group

Sample size：

干预措施：

Usual pre-clinical practicum training

干预措施代码：

Intervention：

Usual pre-clinical practicum training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Tung Wah College 

单位级别：

 University 

Institution
hospital：

Tung Wah College

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Resilience level

指标类型：

主要指标

Outcome：

Resilience level

Type：

Primary indicator

测量时间点：

T0, T1, T2 and T3

测量方法：

Connor–Davidson Resilience Scale 10

Measure time point of outcome：

T0, T1, T2 and T3

Measure method：

Connor–Davidson Resilience Scale 10

指标中文名：

Depression, anxiety, and stress levels

指标类型：

次要指标

Outcome：

Depression, anxiety, and stress levels

Type：

Secondary indicator

测量时间点：

T0, T1, T2 and T3

测量方法：

Depression Anxiety and Stress Scale 21

Measure time point of outcome：

T0, T1, T2 and T3

Measure method：

Depression Anxiety and Stress Scale 21

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

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 18 岁 years
最大 Max age 30 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）：

The research assistant will randomly assign the participants into wait-list control and intervention groups at a 1:1 ratio using a web-based application www.randomizer.org.

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

The research assistant will randomly assign the participants into wait-list control and intervention groups at a 1:1 ratio using a web-based application www.randomizer.org.

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：

None

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

The data will be available upon request.

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

The data will be available upon request.

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：

None

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

None

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：

  2024-11-21 16:29:38
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

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

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统