动机性访谈在心肌梗死PCI术后患者运动恐惧、社会支持、和运动自我效能的影响:一项随机对照实验

注册号:

Registration number:

ChiCTR2600116205 

最近更新日期:

Date of Last Refreshed on:

2026-01-06 18:03:36 

注册时间:

Date of Registration:

2026-01-06 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

动机性访谈在心肌梗死PCI术后患者运动恐惧、社会支持、和运动自我效能的影响:一项随机对照实验

Public title:

Effects of motivational interviewing on kinesiophobia,social support and exercise self-efficacy of patients with myocardial infarction after PCI : a randomized controlled trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

动机性访谈在心肌梗死PCI术后患者运动恐惧、社会支持、和运动自我效能的影响:一项随机对照实验

Scientific title:

Effects of motivational interviewing on kinesiophobia,social support and exercise self-efficacy of patients with myocardial infarction after PCI : a randomized 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:

张曦云 

研究负责人:

张曦云 

Applicant:

Xiyun Zhang 

Study leader:

Xiyun Zhang 

申请注册联系人电话:

Applicant telephone:

+86 199 6855 1849

研究负责人电话:

Study leader's
telephone:

+86 199 6855 1849

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:

15193666169@163.com

研究负责人电子邮件:

Study leader's E-mail:

15193666169@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:

甘肃省兰州市城关区天水南路222号

研究负责人通讯地址:

甘肃省兰州市城关区天水南路222号

Applicant address:

School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, China

Study leader's address:

School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, 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:

兰州大学护理学院 兰州大学第二医院

Applicant's institution:

School of Nursing, Lanzhou University

研究负责人所在单位:

兰州大学护理学院 兰州大学第二医院

Affiliation of the Leader:

School of Nursing, Lanzhou University The Second Hospital of Lanzhou 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:

LZUHLXY20250051

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:

兰州大学护理学院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the School of Nursing, Lanzhou University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-09-15 00:00:00

伦理委员会联系人:

韩琳

Contact Name of the ethic committee:

Han Lin

伦理委员会联系地址:

甘肃省兰州市城关区天水南路222号

Contact Address of the ethic committee:

School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 181 5363 0523

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:

兰州大学护理学院

Primary sponsor:

School of Nursing, Lanzhou University

研究实施负责(组长)单位地址:

甘肃省兰州市城关区天水南路222号

Primary sponsor's address:

School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, 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):

甘肃省

市(区县):

Country:

China

Province:

Gansu Province

City:

单位(医院):

兰州大学护理学院

具体地址:

甘肃省兰州市城关区天水南路222号

Institution
hospital:

School of Nursing, Lanzhou University

Address:

School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, China

经费或物资来源:

中央高校基本科研业务费项目lzujbky-2023-42

Source(s) of funding:

Central Universities Basic Research Operating Expenses Project lzujbky-2023-42

研究疾病:

心肌梗死  

Target disease:

Myocardial infarction

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:

I期临床试验 

Study phase:

1

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

探索动机性访谈对心肌梗死PCI术后患者运动恐惧、社会支持和运动自我效能等的干预效果,以期为心肌梗死PCI术后运动恐惧患者的护理干预提供借鉴。  

Objectives of Study:

To explore the effects of motivational interviewing on exercise-related fears, social support, and exercise self-efficacy among patients who underwent percutaneous coronary intervention (PCI) for myocardial infarction, with the aim of providing insights for nursing interventions targeting exercise-related fears in this patient population.

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.存在重度认知功能损害或严重精神疾患,丧失语言及非语言交流能力的患者; 2.处于术后急性不良事件期或进展性器官功能障碍的患者; 3.近期正在参与其他研究的患者。

Exclusion criteria:

1. Patients with severe cognitive impairment or serious psychiatric disorders who have lost the ability to communicate verbally or non-verbally; 2. Patients in the acute adverse event phase following surgery or experiencing progressive organ dysfunction; 3. Patients currently participating in other studies.

研究实施时间:

Study execute time:

From 2025-09-27 00:00:00 To 2028-09-27 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-01-05 00:00:00 To 2028-09-27 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

44

Group:

control group

Sample size:

干预措施:

对照组实施常规的护理干预,包括一般资料评估、休息与饮食指导、健康宣教及出院指导。 (1)一般资料评估:由研究者本人系统收集患者的完整人口学资料,同时完成生命体征监测与标准化量表测评。所有数据采集工作均采用双人核对机制以确保准确性。 (2)休息与饮食干预:对行PCI治疗的患者,实施分阶段康复干预。初期重点落实环境调控措施,维持病房光线柔化与声噪管控,规范探视制度以保障治疗性静养。同步开展营养指导计划,强调控制总热量摄入,优先选择富含不饱和脂肪酸及粗纤维的食材,建立定时定量进餐制度,配合腹部按摩等物理干预手段促进肠道蠕动功能。 (3)健康宣教:术后向患者进行健康宣教,优化健康轨迹,防控疾病相关的高危因素。 (4)出院指导:出院后通过电话、微信等方式对患者进行健康教育,叮嘱其定期复查,对因故不能复查的患者,由研究者本人跟踪随访流程,通过电话问诊与门诊复诊相结合的方式完成疗效评估数据采集。

干预措施代码:

Intervention:

The control group received routine nursing interventions, including assessment of general information, guidance on rest and diet, health education, and discharge instructions. (1) General Data Assessment: The investigator systematically collected complete demographic data from patients while monitoring vital signs and administering standardized scales. All data collection employed a dual-verification mechanism to ensure accuracy. (2) Rest and Dietary Intervention: Patients undergoing PCI received phased rehabilitation interventions. Initial focus was on environmental control measures, maintaining soft lighting and noise reduction in the ward, and standardizing visitation protocols to ensure therapeutic rest. Concurrently, a nutritional guidance plan was implemented, emphasizing total calorie intake control, prioritizing foods rich in unsaturated fatty acids and dietary fiber, establishing a regular meal schedule with fixed portions, and incorporating physical interventions such as abdominal massage to promote intestinal motility. (3) Health Education: Postoperatively, patients receive health education to optimize health trajectories and prevent disease-related risk factors. (4) Discharge Guidance: Post-discharge health education is provided via telephone or WeChat, reminding patients of scheduled follow-ups. For those unable to attend, the investigator personally tracks follow-up procedures, collecting efficacy assessment data through a combination of telephone consultations and outpatient visits.

Intervention code:

组别:

干预组

样本量:

44

Group:

Intervention group

Sample size:

干预措施:

在常规护理的基础上对心肌梗死PCI术后患者实施动机性访谈。 1.第1次访谈:术后当天,在示教室或病房,进行面对面个体干预,访谈时长为15-30分钟。该阶段的访谈目的是通过开放式提问,了解患者的核心关切和内在冲突,通过共情、非评判性态度和反应式倾听,与患者建立合作性关系,使其感到尊重和理解,帮助患者从模糊的困扰中聚焦到具体可改变的领域。访谈内容主要包括了解患者病程、治疗经历以及遇到的困难,建立信任与共情基础。了解患者对疾病的看法,扭转其的错误认知。询问患者生活方式(有无吸烟饮酒习惯、饮食口味偏好、睡眠质量如何)、个人喜好,逐步过渡到运动情况。评估、了解和接纳患者运动过程中产生的负性情绪,并逐步聚焦于运动恐惧此主题,避免与其直接争论,及时采用合适的方式对其运动恐惧心理问题进行疏导。最后对患者表示感谢并预约下次访谈时间。 2.第2次访谈:术后第1天,在示教室或病房,进行面对面个体干预,访谈时长为15-30分钟。该阶段的访谈目的是帮助患者从目标与需求中挖掘改变的深层理由,使其接纳矛盾心理的普遍性,同时引导患者对比“维持现状”与“改变”的利弊,增强其对改变的信心与承诺。访谈内容主要包括了解患者目前运动恐惧现状,评估术后运动时的困难与阻碍,探索运动恐惧的原因。与患者讨论术后不运动会造成什么影响,为让其意识到运动的重要性做好铺垫。帮助患者回顾擅长的运动种类与运动经历,唤醒运动意愿。与患者共同展望术后运动方式以及运动带来的好处,加强运动信念。让患者对增强术后运动积极性提出自己的意见,通过调动患者的参与感以增强其对于运动的热情。最后对患者表示感谢并预约下次访谈时间。 3.第3次访谈:术后第2天,在示教室或病房,进行面对面个体干预,访谈时长为15-30分钟。该阶段的访谈目的是帮助患者从抽象的改变意愿过渡到可操作的行为目标,以及与患者共同制定可行性策略,加强其参与感与自主性。访谈内容主要包括基于患者目前健康状况、运动情况和运动喜好与其共同商讨目前以及出院后的运动计划。充分发挥患者参与疾病管理的自主性,让其从被动的接受者转变为积极的参与者,激发自我效能,降低运动恐惧水平。最后对患者表示感谢并预约下次访谈时间。 4.第4次访谈:出院第1个月,利用微信或电话,进行一对一个体干预,访谈时长为15-30分钟。该阶段的访谈目的是通过患者的客观陈述,帮助患者更清晰的认识到当前改变所带来的影响,和改变过程中存在的问题并及时加以解决,从而提升自我效能感,增强其长期改变的决心。访谈内容主要包括追踪患者访谈效果,肯定运动成效,增强运动信心。了解患者最近运动过程中的感受,评估目前运动时的恐惧情况,引导患者思考坚持运动所带来的变化与益处,以增强其长期改变的决心。询问患者在运动康复过程中遇到的问题,整合优势资源,及时对运动计划进行调整,增强其长期运动的意愿与能力。最后对患者表示感谢并预约下次访谈时间。 5.第5次访谈:出院第2个月,利用微信或电话,进行一对一个体干预,访谈时长为15-30分钟。该阶段的访谈目的是帮助患者明确直接的承诺,强化内在动机,防止因矛盾情绪或短期困难而削弱改变的决心。访谈内容主要包括对患者这段时间的进步继续给予肯定,增强其继续改变的信心,强化运动带来的积极影响。了解患者当前运动状态与感受,探索潜在的运动障碍,制定应对策略。对于想放弃的患者,通过OARS技能(开放式提问、肯定、反思性倾听和总结),帮助他们重新聚焦、思考与探讨现在的问题。最后对患者表示感谢并预约下次访谈时间。 6.第6次访谈:出院第3个月,利用微信或电话,进行一对一个体干预,访谈时长为15-30分钟。该阶段的访谈目的是通过正向强化与未来导向的对话,将短期成功转化为持续动力。访谈内容主要包括对患者所取得的进步继续表示肯定,增强其长期改变的信心。了解患者目前的身心感受,带领患者回顾第1次访谈到最后1次访谈的过程中的改变。用半开放式的提问让患者描述自己目前的感受,以及对未来的信心和愿望。与其讨论未来克服运动恐惧、坚持运动锻炼的能力与方法。最后对患者表示感谢并且提供持续资源与开放性渠道。

干预措施代码:

Intervention:

Intervention Content: Conduct motivational interviewing for patients undergoing PCI for myocardial infarction, in addition to routine care. 1.First Interview: On the day of surgery, conduct a face-to-face individual intervention in the teaching room or ward, lasting 15-30 minutes. The purpose of this stage is to use open-ended questions to understand the patient's core concerns and internal conflicts. Through empathy, a non-judgmental attitude, and responsive listening, a collaborative relationship is established, making the patient feel respected and understood. This helps shift focus from vague distress to specific, actionable areas for change. Key topics include understanding the patient's medical history, treatment experiences, and encountered difficulties, laying the foundation for trust and empathy. Understand the patient's perspective on their illness and correct any misconceptions. Inquire about lifestyle habits (smoking/drinking habits, dietary preferences, sleep quality), personal preferences, and gradually transition to discussing exercise habits. Assess, acknowledge, and accept any negative emotions arising during exercise, gradually focusing on the theme of exercise-related fears. Avoid direct confrontation and promptly employ appropriate methods to address the patient's psychological concerns related to exercise anxiety. Conclude by expressing gratitude and scheduling the next appointment. 2.Second Interview: Day 1 post-surgery. Conduct a 15-30 minute face-to-face individual intervention in a teaching room or hospital ward. The purpose of this stage is to help patients uncover deeper motivations for change from their goals and needs, accept the universality of conflicting emotions, and guide them to weigh the pros and cons of "maintaining the status quo" versus "change," thereby strengthening their confidence and commitment to change. Key discussion points include: Discussions with patients about the consequences of avoiding exercise post-surgery lay the groundwork for recognizing its importance. Patients are assisted in recalling their preferred exercise types and past experiences to rekindle motivation. Jointly envisioning post-surgery exercise routines and their benefits strengthens patients' belief in exercise. Patients are encouraged to suggest ways to boost their post-surgery exercise enthusiasm, fostering engagement to heighten their passion for physical activity. The session concludes with gratitude and scheduling the next interview. 3. Third Interview: Day 2 post-surgery. Conducted face-to-face in a classroom or ward setting, lasting 15-30 minutes. This phase aims to help patients transition from abstract change intentions to actionable behavioral goals, collaboratively develop feasible strategies, and strengthen their sense of involvement and autonomy. The discussion primarily involves jointly planning current and post-discharge exercise regimens based on the patient's current health status, exercise habits, and preferences. This fully leverages the patient's autonomy in disease management, transforming them from a passive recipient to an active participant, thereby boosting self-efficacy and reducing exercise anxiety. Finally, express gratitude to the patient and schedule the next interview. 4. Fourth Interview: Conducted one month post-discharge via WeChat or phone, this one-on-one intervention lasts 15-30 minutes. The purpose is to help patients objectively assess the impact of their current changes, identify and resolve challenges encountered during the process, thereby enhancing self-efficacy and strengthening their commitment to long-term change. Key discussion points include: - Tracking interview effectiveness and affirming exercise achievements to build confidence. - Understanding recent exercise experiences and assessing current fear levels during activity. - Guiding patients to reflect on changes and benefits from consistent exercise to strengthen long-term commitment. - Identifying challenges in the exercise rehabilitation process, integrating available resources, and adjusting exercise plans as needed to enhance willingness and ability for sustained activity. - Concluding with gratitude and scheduling the next session. 5. Fifth Interview: Conducted one month post-discharge via WeChat or phone, this 15-30 minute one-on-one intervention aims to clarify immediate commitments, reinforce intrinsic motivation, and prevent wavering resolve due to conflicting emotions or short-term challenges. Key discussion points include: - Reaffirming progress made during this period to bolster confidence in continued change and highlight exercise's positive impacts. - Assessing current exercise status and feelings, identifying potential barriers, and developing coping strategies. - For patients contemplating quitting, employ OARS skills (Open-ended questions, Affirmation, Reflective listening, Summarizing) to refocus attention, reflect on, and discuss current challenges. - Conclude by thanking the patient and scheduling the next session. 6. Sixth Interview: Conducted via WeChat or phone call at three months post-discharge, lasting 15-30 minutes. This phase aims to translate short-term successes into sustained momentum through positive reinforcement and future-oriented dialogue. Key discussion points include: - Continuing to affirm the patient's progress to strengthen confidence in long-term change. - Understanding the patient's current physical and emotional state. - Guiding the patient to reflect on changes from the first to the final session. - Using semi-open-ended questions to encourage the patient to describe their current feelings, future confidence, and aspirations. - Discussing future strategies and methods for overcoming exercise-related fears and maintaining physical activity. Conclude by thanking the patient and offering ongoing resources and open communication channels.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

甘肃省 

市(区县):

 

Country:

China

Province:

Gansu Province

City:

单位(医院):

兰州大学第二医院 

单位级别:

三甲 

Institution
hospital:

The Second Hospital of Lanzhou University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

运动恐惧

指标类型:

主要指标

Outcome:

Kinesiophobia

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会支持度

指标类型:

主要指标

Outcome:

Level of social support

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自我效能感

指标类型:

主要指标

Outcome:

self-efficacy

Type:

Primary 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:

组织:

Sample Name:

no

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

为避免沾染,采用便利抽样法,按照兰州市某三甲医院心内科心肌梗死PCI术后患者的入院顺序,将2024年1月-2024年4月符合条件的患者列为对照组,将2024年5月-2024年8月符合条件的患者列为干预组。

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

To avoid contamination, a convenience sampling method was employed. Patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction at the cardiology department of a tertiary hospital in Lanzhou were enrolled in the order of their admission. Eligible patients from January to April 2024 were assigned to the control group, while those from May to August 2024 were assigned to the intervention group.

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:

开放标签

Blinding:

Open label

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

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):

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:

EDC

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

EDC

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:

 2026-01-06 18:03:30