|
注册号: Registration number: |
ChiCTR2500105950 |
|
最近更新日期: Date of Last Refreshed on: |
2025-07-15 09:56:13 |
|
注册时间: Date of Registration: |
2025-07-15 00:00:00 |
|
注册号状态: |
预注册 |
|
Registration Status: |
Prospective registration |
|
注册题目: |
针刺及运动对高拖延水平大学生作用的脑电特征与认知控制研究 |
|
Public title: |
Effects of Acupuncture and Exercise on EEG Characteristics and Cognitive Control in College Students with High Procrastination Tendency |
|
注册题目简写: |
|
|
English Acronym: |
|
|
研究课题的正式科学名称: |
针刺及有氧运动对高拖延水平大学生作用的脑电特征与认知控制研究 |
|
Scientific title: |
Effects of Acupuncture and Aerobic Exercise on EEG Characteristics and Cognitive Control in College Students with High Procrastination Tendency |
|
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: |
陈新旺 |
研究负责人: |
陈新旺 |
|
Applicant: |
Chen Xinwang |
Study leader: |
Chen Xinwang |
|
申请注册联系人电话: Applicant telephone: |
+86 135 2665 2895 |
研究负责人电话:
Study leader's |
+86 135 2665 2895 |
|
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: |
cxw23161@126.com |
研究负责人电子邮件: Study leader's E-mail: |
cxw23161@126.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: |
河南省郑州市金水区东明路63号 |
研究负责人通讯地址: |
河南省郑州市金水区东明路63号 |
|
Applicant address: |
63 Dongming Road, Jinshui District, Zhengzhou City, Henan Province |
Study leader's address: |
63 Dongming Road, Jinshui District, Zhengzhou City, Henan Province |
|
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: |
河南中医药大学第三附属医院 |
||
|
Applicant's institution: |
Third Affiliated Hospital of Henan University of traditional Chinese Medicine |
||
|
研究负责人所在单位: |
河南中医药大学第三附属医院 |
||
|
Affiliation of the Leader: |
Third Affiliated Hospital of Henan University of traditional Chinese Medicine |
||
|
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: |
2025HL-017 |
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: |
河南中医药大学第三附属医院伦理委员会 |
||
|
Name of the ethic committee: |
Ethics Committee of the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine |
||
|
伦理委员会批准日期: Date of approved by ethic committee: |
2025-02-27 00:00:00 | ||
|
伦理委员会联系人: |
张晓东 |
||
|
Contact Name of the ethic committee: |
Zhang Xiaodong |
||
|
伦理委员会联系地址: |
河南省郑州市金水区东明路63号 |
||
|
Contact Address of the ethic committee: |
63 Dongming Road, Jinshui District, Zhengzhou City, Henan Province |
||
|
伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 371 5628 3080 |
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: |
河南中医药大学第三附属医院 |
||||||||||||||||||||||
|
Primary sponsor: |
Third Affiliated Hospital of Henan University of traditional Chinese Medicine |
||||||||||||||||||||||
|
研究实施负责(组长)单位地址: |
河南省郑州市金水区东明路63号 |
||||||||||||||||||||||
|
Primary sponsor's address: |
63 Dongming Road, Jinshui District, Zhengzhou City, Henan Province |
||||||||||||||||||||||
|
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||
|
经费或物资来源: |
河南中医药大学双一流学科建设项目 |
||||||||||||||||||||||
|
Source(s) of funding: |
The Double First-Class Discipline Construction Project of Henan University of Chinese Medicine |
||||||||||||||||||||||
|
研究疾病: |
拖延症 |
||||||||||||||||||||||
|
Target disease: |
Procrastination |
||||||||||||||||||||||
|
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: |
观察拖延症人群的ERP特征,评价针刺干预拖延症认知功能的临床疗效,探索针刺干预对拖延症人群认知功能影响的ERP变化。 |
||||||||||||||||||||||
|
Objectives of Study: |
To observe the ERP (Event-Related Potentials) characteristics in individuals with procrastination, evaluate the clinical efficacy of acupuncture intervention on the cognitive function of procrastination, and explore the ERP changes in the cognitive function of individuals with procrastination influenced by acupuncture intervention. |
||||||||||||||||||||||
|
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) 器质性精神障碍,或与手术史、精神活性物质相关的疾病; (2) 有家族其他精神病史如:痴呆、精神分裂、躁狂、瘾症等; (3) 存在意识障碍或躁动不能配合完成范式任务及EEG采集的受试者; (4) 合并有皮损或皮肤病患者。 健康志愿者排除标准 (1) 有急性或慢性疼痛的受试者、服用止痛药或精神药物的受试者; (2) 有妊娠、哺乳、或皮损或皮肤病患者; (3) 存在意识障碍或躁动不能配合完成范式任务及EEG采集的受试者; |
||||||||||||||||||||||
|
Exclusion criteria: |
(1) Organic mental disorders, or diseases related to surgical history or psychoactive substances; (2) Having other family histories of mental illnesses such as dementia, schizophrenia, mania, hysteria, etc.; (3) Subjects with disturbances of consciousness or restlessness who are unable to cooperate in completing paradigm tasks and EEG collection; (4) Patients with concurrent skin lesions or skin diseases. Exclusion criteria for healthy volunteers (1) Subjects with acute or chronic pain, subjects taking painkillers or psychotropic drugs; (2) Patients who are pregnant, breastfeeding, or have skin lesions or skin diseases; (3) Subjects with consciousness disorders or restlessness who are unable to cooperate in completing paradigm tasks and EEG collection. |
||||||||||||||||||||||
|
研究实施时间: Study execute time: |
从 From 2025-07-25 00:00:00至 To 2028-06-20 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-07-25 00:00:00 至 To 2028-06-20 00:00:00 |
|
干预措施: Interventions: |
|
|
研究实施地点: Countries of recruitment and research settings: |
|
||||||||||||||||||||||||||||
|
测量指标: Outcomes: |
|
|
采集人体标本:
Collecting sample(s)
|
|
|
征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
|
||||||
|
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): |
采用计算机简单随机化方法,把估算的样本含量输入SPSS 21.0 统计软件包,生成随机种子、生成随机数字、得到排列顺序转换得到分组结果,制作随机卡片,放入不透光信封密封。临床实施时将合格病例纳入试验的先后顺序对应信封上的序号顺序拆开信封,依照随机卡片上的提示进行分组。 |
||||||||
|
Randomization Procedure (please state who generates the random number sequence and by what method): |
Computerized simple randomization method was used to input the estimated sample content into the SPSS 21.0 statistical software package, generate random seeds, generate random numbers, get the order of conversion to get the grouping results, make random cards, and put them into opaque envelopes for sealing. During clinical implementation, the order of inclusion of qualified cases in the trial corresponded to the order of the serial number on the envelope to open the envelope, in accordance with the prompts on the randomization card for grouping. |
||||||||
|
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: |
单盲 |
|
Blinding: |
Single blindeded |
|
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): |
接受河南中医药大学伦理委员会和相关人员的数据监察 |
|
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Accept data monitoring by Ethics Committee of Henan University of Chinese Medicine and relevant personnel. |
|
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: |
病例记录表 |
|
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form, CRF |
|
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |