ChiCTR2500111345 版本V1.0 版本创建时间2025/10/30 08:29:26 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：

 ChiCTR2500111345 

最近更新日期：

Date of Last Refreshed on：

 2025-10-30 08:29:21 

注册时间：

Date of Registration：

 2025-10-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

「正念關懷計劃（MBCP）對減輕護士壓力、提升工作滿意度及留職意願的效果：隨機對照試驗」

Public title：

Effects of a Mindfulness-based Caring program (MBCP) on reducing nurse stress, enhancing job satisfaction and retention: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

「正念關懷計劃（MBCP）對減輕護士壓力、提升工作滿意度及留職意願的效果：隨機對照試驗」

Scientific title：

Effects of a Mindfulness-based Caring program (MBCP) on reducing nurse stress, enhancing job satisfaction and retention: A randomized controlled trial

研究课题代号(代码)：

Study subject ID：

 2025.437

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：

UW 25-403

申请注册联系人：

王詠怡 

研究负责人：

王詠怡 

Applicant：

Wong wing yee 

Study leader：

Wong wing yee 

申请注册联系人电话：

Applicant telephone：

 +852 6048 8665

研究负责人电话：

Study leader's
telephone：

+852 6048 8665

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：

 1155074919@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1155074919@link.cuhk.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：

香港新界沙田赤泥坪村127號地下

研究负责人通讯地址：

香港新界沙田赤泥坪村127號地下

Applicant address：

G/F, 127, CHEK NAI PING VILLAGE, SHATIN, NT, HONG KONG

Study leader's address：

G/F, 127, CHEK NAI PING VILLAGE, SHATIN, NT, 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：

香港中文大學護理部

Applicant's institution：

The Chinese University of Hong Kong, The Nethersole School of Nursing

研究负责人所在单位：

香港中文大學護理部

Affiliation of the Leader：

The Chinese University of Hong Kong, The Nethersole School of Nursing

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：

 Joint CUHK-NTEC CREC (2025.437) and HKU/ HA HKW IRB (UW 25-403)

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：

本研究已通過 香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會(Joint CUHK-NTEC CREC) [CRE參考編號： 2025.437] 以及香港大學及醫院管理局港島西醫院聯網研究倫理委員會(HKU/ HA HKW IRB) [CRE 參考編號: UW 25-403] 的審批。委員會是獲授權機構之一，可為倫理審查目的查閱與本研究相關的受試者記錄。

Name of the ethic committee：

Joint CUHK-NTEC CREC and HKU/ HA HKW IRB

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-03 00:00:00

伦理委员会联系人：

新界東醫院聯網臨床研究倫理聯席委員會

Contact Name of the ethic committee：

Joint CUHK-NTEC CREC

伦理委员会联系地址：

香港沙田威爾斯親王醫院呂志和臨床醫學大樓8樓香港中文大學 – 新界東醫院聯網臨床研究倫理 聯席委員會

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

香港中文大學護理部

Primary sponsor：

The Chinese University of Hong Kong, The Nethersole School of Nursing

研究实施负责（组长）单位地址：

香港新界沙田赤泥坪村127號地下

Primary sponsor's address：

G/F, 127, CHEK NAI PING VILLAGE, SHATIN, NT, HONG KONG

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong

City：

单位(医院)：

葛量洪醫院

具体地址：

葛量洪醫院, 香港仔黃竹坑125號

Institution
hospital：

Grantham Hospital

Address：

125 Wong Chuk Hang Road, Aberdeen, HK

经费或物资来源：

沒有

Source(s) of funding：

nil sponsor

研究疾病：

護士壓力  

Target disease：

Nurse stress

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

研究目標是探討該計劃是否能有效減輕壓力、提升工作滿意度及護士留職意願，以促進護士的心理健康與職業福祉。  

Objectives of Study：

The aim of this study is to determine whether the Mindfulness-based caring program (MBCP) can help reduce stress and improve job satisfaction among nurses, ultimately contributing to better retention in the nursing profession.

药物成份或治疗方案详述：

「正念關懷計劃（MBCP）」為期四週，每週進行一次，每次兩小時的課程於醫院會議室舉行，旨在將正念練習與關懷科學原則相結合。每節課程由一名護士及一名具臨床心理學家資格的正念教練共同帶領，聚焦於Jean Watson「人性關懷理論」中的特定關懷過程（Caritas Processes）。正念教練負責指導正念練習的教學，參與者將學習多種正念技巧，包括「慈心禪」、「正念呼吸」及「慈悲冥想」，以提升自我覺察、同理心及情緒韌性。而受過正念與關懷科學培訓的護士則會模擬真實臨床情境，引導討論環節，協助參與者將正念技巧應用於實際工作中，以有效管理壓力並預防職業倦怠。 除每週課程外，參與者需每日進行至少10分鐘的家居練習，鞏固所學概念並鼓勵將正念融入日常生活中。我們將透過 WhatsApp 向參與者發送正念語錄、音頻或視頻等資料，以強化課程中所學的練習內容，並提醒他們持續進行每日家居練習。此外，鼓勵參與者每週撰寫簡短反思，分享如何將正念練習應用於日常工作中。本研究旨在應對醫護人員（尤其是護士）因病人及家屬期望而日益增加的壓力。「正念關懷計劃（MBCP）」特別為護士設計，幫助他們深入理解正念練習，並將其應用於日常護理工作中。課程結束後，流程評估將包括一份匿名回饋調查及一場 15 至 20 分鐘的半結構式訪談，以探討參與者的經驗及實施忠實度。 通過參與此計劃，護士將學習緩解工作壓力的技巧，提升有效應對挑戰的能力。同時，計劃強調以慈悲之心照護病人，使護士能在關懷患者的同時，兼顧自身福祉。最終，此計劃期望為護士創造更健康的工作環境，並提升病人照護的質素。  

Description for medicine or protocol of treatment in detail：

This research study aims to evaluate the effectiveness of a 4-week Mindfulness-Based Caring Program (MBCP) designed specifically for nurses. The program is based on Jean Watson’s Theory of Human Caring, which emphasizes the importance of mindfulness practice in healthcare to facilitate nurses' well-being. We are inviting registered or enrolled nurses currently working in Grantham Hospital to participate in this study. Participants will be randomly assigned to one of two groups, in a one-to-one ratio: the intervention group, which will receive the MBCP, or the waitlist control group, who will continue to voluntarily participate in the usual training offered by the corporate and cluster staff training programs. A pilot study with a sample size of 24 participants (12 participants in each arm, intervention and control groups) will be conducted, aiming to evaluate the feasibility and preliminary effectiveness of a 4-week Mindfulness-Based Caring Program (MBCP) for reducing stress among nurses. The sample size calculation of the pilot study was based on guidelines for pilot RCTs (Julious, 2005; Whitehead et al., 2014), the need to assess feasibility and estimate variability, and the context of the main study’s sample size planning. This sample size is sufficient to evaluate recruitment, retention, intervention delivery, and outcome measurement while accounting for potential attrition (up to 20%). It also aligns with the main study’s effect size (Cohen’s d = 0.682) and provides a practical, resource-efficient approach to inform the design of the larger RCT. By testing these elements in a smaller cohort, the pilot study will enhance the methodological rigor and feasibility of the main study evaluating mindfulness-based interventions for stress reduction in nurses. The Mindfulness-Based Caring Program (MBCP) consists of four weekly sessions, each lasting 2 hours, located at the hospital conference room, designed to integrate mindfulness practices with caring science principles. Each session, facilitated by a nurse and a qualified mindfulness coach who is a clinical psychologist, focuses on specific Caritas Processes derived from Jean Watson’s theory of Human Caring. The mindfulness coach supports mindfulness practice delivery, participants will learn mindfulness techniques, including Meditation, Mindful Breathing, designed to enhance self-awareness, empathy, and emotional resilience. While the nurse, trained in mindfulness and caring science, demonstrates real-life scenarios, fostering discussions that help participants apply mindfulness skills in clinical settings to manage stress. In addition to the weekly sessions, participants will engage in daily home practice for at least 5 minutes, reinforcing the concepts covered and encouraging consistent mindfulness application in their daily lives. Information such as mindfulness quotes, audio, or videos will be sent to participants via WhatsApp to reinforce the practices they learned during the sessions and to remind them of their daily home practice. Additionally, participants are encouraged to write a brief reflection weekly to share how they have applied mindfulness practices in their daily work. This study aims to address the increasing levels of stress faced by healthcare workers, particularly nurses, due to patients’ and families’ expectations. The Mindfulness-Based Caring Program (MBCP) is designed to foster a deeper understanding of mindfulness practices, specifically tailored to help nurses integrate mindfulness into their daily work. After the program, the process evaluation will include an anonymous feedback survey and a 15-20 minute semi-structured interview to explore participants' experiences and implementation fidelity. By participating in this program, nurses will learn techniques to relieve work-related stress, enhancing their ability to manage challenges effectively. Additionally, the program promotes a compassionate presence in patient care, enabling nurses to provide better support to their patients while also prioritizing their own well-being. Ultimately, this approach seeks to create a healthier work environment for nurses and improve the quality of care delivered to patients. During the study, participants will complete three sets of questionnaires to assess their stress levels, job satisfaction, and retention intentions at three different times: before the program starts (Week 0), immediately after the program ends (Week 4), and three months later (Week 16). The intervention group will also attend four online mindfulness sessions and keep a brief weekly reflective journal. The goal of this study is to determine whether the MBCP can help reduce stress and improve job satisfaction among nurses, ultimately contributing to better retention in the nursing profession. 

纳入标准：

參與資格: 符合以下條件即可參與本研究： ? 現職於香港醫療機構的登記或註冊護士 ? 具備至少六個月臨床經驗的護士，並於住院病房或診所環境工作的護士 ? 能閱讀及理解中文/英文 ? 擁有智能手機或電腦，可進行網上參與

Inclusion criteria

This study will include registered or enrolled nurses currently working at Grantham Hospital. Nurses with at least 6 months of clinical experience, working in either in-patient wards or clinic settings, who have finished the cluster orientation program and ward induction program that are routinely performed for all new graduates. Participants can listen, speak, read, write and understand Chinese and English, and have access to a smartphone or computer for online participation. The participants could be able to complete the outcome assessment tools in English, and the Principal Investigator will be onsite to assist the participants for completing the outcome assessment tools if any queries.

排除标准：

排除標準包括護理學生或正在接受培訓的護理人員，以及目前正在接受輔導或其他壓力管理療法，可能干擾研究的護理人員。

Exclusion criteria：

Exclusion criteria include nurse students or those under training, or nurses who are currently undergoing counseling or other stress management therapies that might interfere with the study.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2026-11-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-01 00:00:00 至 To 2026-11-20 00:00:00

干预措施：

Interventions：

组别：

干预組

样本量：

 12

Group：

intervention

Sample size：

干预措施：

「正念關懷計劃（MBCP）」

干预措施代码：

 MBCP

Intervention：

Mindfulness-Based Caring Program

Intervention code：

组别：

等候對照組

样本量：

 12

Group：

control

Sample size：

干预措施：

沒有干预

干预措施代码：

 Control

Intervention：

no intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 葛量洪醫院 

单位级别：

 N/A 

Institution
hospital：

Grantham Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

壓力感受

指标类型：

主要指标

Outcome：

Perceived stress

Type：

Primary indicator

测量时间点：

介入前、為期四週的計劃完成後，以及在計劃完成後三個月

测量方法：

壓力感受量表（PSS-10）

Measure time point of outcome：

before, after intervention, 3 months after the 4-week program completed

Measure method：

Perceived stress scale (PSS-10)

指标中文名：

工作满意度调查（JSS）

指标类型：

次要指标

Outcome：

Job Satisfaction Survey, JSS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

护士留任量表 (NRS)

指标类型：

次要指标

Outcome：

Nurse Retention Scale, NRS

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 65 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）：

隨機分配程序旨在確保參與者在介入組和對照組之間的均等分配，同時滿足值班安排的後勤要求。本研究從6個病房招募護理人員，每個病房提名4名工作人員參加該計劃。 為了實現平衡的組別分配，採用了區塊隨機化方法。每個病房構成一個單獨的區塊，每個區塊中隨機分配2名參與者至介入組，另外2名參與者分配至對照組。此方法確保每個病房的參與者數量在兩組之間均勻分配，從而在病房內部及病房之間保持平衡。 隨機分配過程通過電腦隨機數生成器為每個區塊（病房）生成隨機序列，並根據這些序列將參與者分配到各自的組別中。一名文書人員協助生成隨機數序列並執行隨機分配程序，將參與者分配到相應的組別。區塊隨機化方法確保了分配的隨機性和公平性，最大限度地減少了潛在的選擇偏倚，並支持病房的後勤需求。

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

The randomisation procedure was designed to ensure equal allocation of participants to the intervention and control groups while accommodating the logistical requirements of duty arrangements. The study involved nurses recruited from 6 wards, with each ward nominating 4 staff members to participate in the program. To achieve balanced group allocation, a block randomisation method was employed. Each ward constituted a separate block, with 2 participants randomly assigned to the intervention group and the remaining 2 participants assigned to the control group. This approach ensured that equal numbers of participants from each ward were distributed across the two groups, thereby maintaining balance within and across wards. The randomisation process involved generating random sequences for each block (ward) using a computer-based random number generator. These sequences were used to assign participants within each ward to their respective groups. A clerical staff will assist to generate the random number sequence for randomization and assign to each participants. The block randomisation methodology ensured that allocation was both random and equitable, minimizing potential selection bias and supporting the logistical requirements of the wards.

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：

資料輸入人員並未被告知參與者的組別分配（介入組或對照組）。此舉確保了資料輸入與分析的客觀性，不會受到分組資訊的影響。通過採用此方法，在資料處理階段觀察者偏倚或確認偏倚的風險被降至最低，從而提高了研究結果的整體有效性與可靠性。

Blinding：

The data input staff were not informed of the participants' group assignments (intervention or control). This ensured that data entry and analysis were conducted objectively, without any influence from knowledge of group allocation. By implementing this approach, the risk of observer or confirmation bias during the data handling phase was minimized, enhancing the overall validity and reliability of the study's findings.

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）：

資料將在主要研究結果發表後進行共享。

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

The data will be shared after the primary study results have been published.

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：

本研究將使用標準的數據收集和管理系統，以確保試驗數據的準確性、一致性和安全性。數據將通過結構化的病例報告表（CRF）進行收集，該表格將專門為本次試驗設計，用於記錄所有相關的參與者數據，包括基線人口統計資料、臨床結果和不良事件。

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

The study will use a standard data collection and management system to ensure the accuracy, consistency, and security of trial data. Data will be collected using a structured Case Report Form (CRF), which will be designed specifically for this trial to capture all relevant participant data, including baseline demographics, clinical outcomes, and adverse events.

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：

  2025-10-30 08:29:21