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注册号: Registration number: |
ChiCTR2600116205 |
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最近更新日期: Date of Last Refreshed on: |
2026-01-06 18:03:36 |
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注册时间: Date of Registration: |
2026-01-06 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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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 |
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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 |
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注册题目简写: |
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English Acronym: |
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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 |
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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 |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
张曦云 |
研究负责人: |
张曦云 |
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Applicant: |
Xiyun Zhang |
Study leader: |
Xiyun Zhang |
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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 |
+86 199 6855 1849 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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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 |
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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): |
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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 |
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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 |
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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: |
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申请人所在单位: |
兰州大学护理学院 兰州大学第二医院 |
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Applicant's institution: |
School of Nursing, Lanzhou University |
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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 |
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Affiliation of the Leader: |
School of Nursing, Lanzhou University The Second Hospital of Lanzhou University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of the School of Nursing, Lanzhou University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-09-15 00:00:00 | ||
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伦理委员会联系人: |
韩琳 |
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Contact Name of the ethic committee: |
Han Lin |
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伦理委员会联系地址: |
甘肃省兰州市城关区天水南路222号 |
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Contact Address of the ethic committee: |
School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, China |
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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: |
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研究实施负责(组长)单位: |
兰州大学护理学院 |
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Primary sponsor: |
School of Nursing, Lanzhou University |
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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 |
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Primary sponsor's address: |
School of Nursing, Lanzhou University, No. 222, Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
中央高校基本科研业务费项目lzujbky-2023-42 |
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Source(s) of funding: |
Central Universities Basic Research Operating Expenses Project lzujbky-2023-42 |
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研究疾病: |
心肌梗死 |
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Target disease: |
Myocardial infarction |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
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Study phase: |
1 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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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。 |
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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. |
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研究实施时间: Study execute time: |
从 From 2025-09-27 00:00:00至 To 2028-09-27 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-01-05 00:00:00 至 To 2028-09-27 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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。 |
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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. |
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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 |
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盲法: |
开放标签 |
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Blinding: |
Open label |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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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 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
EDC |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |