|
注册号: Registration number: |
ChiCTR2600126427 |
|
最近更新日期: Date of Last Refreshed on: |
2026-06-09 10:46:51 |
|
注册时间: Date of Registration: |
2026-06-09 00:00:00 |
|
注册号状态: |
预注册 |
|
Registration Status: |
Prospective registration |
|
注册题目: |
生涯适应促进满意度的干预研究 |
|
Public title: |
Intervention Study on Promoting Satisfaction Through Career Adaptability |
|
注册题目简写: |
|
|
English Acronym: |
|
|
研究课题的正式科学名称: |
生涯适应促进满意度的潜在机制与干预研究 |
|
Scientific title: |
Underlying Mechanisms Linking Career Adaptability to Life Satisfaction and Intervention Approaches |
|
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: |
王静诗 |
研究负责人: |
苗淼 |
|
Applicant: |
Wang Jingshi |
Study leader: |
Miao Miao |
|
申请注册联系人电话: Applicant telephone: |
+86 130 9123 6559 |
研究负责人电话:
Study leader's |
+86 188 1158 6075 |
|
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: |
2411220029@stu.pku.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
miaomiao@bjmu.edu.cn |
|
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: |
北京市海淀区学院路38号 |
研究负责人通讯地址: |
北京市海淀区学院路38号 |
|
Applicant address: |
38 Xueyuan Road, Haidian District, Beijing |
Study leader's address: |
38 Xueyuan Road, Haidian District, Beijing |
|
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: |
北京大学医学人文学院 |
||
|
Applicant's institution: |
School of Health Humanities, Peking University |
||
|
研究负责人所在单位: |
北京大学医学人文学院 |
||
|
Affiliation of the Leader: |
School of Health Humanities, Peking University |
||
|
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: |
IRB00001052-25166 |
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: |
北京大学生物医学伦理委员会 |
||
|
Name of the ethic committee: |
Peking University Institutional Review Board |
||
|
伦理委员会批准日期: Date of approved by ethic committee: |
2025-12-03 00:00:00 | ||
|
伦理委员会联系人: |
李洁 |
||
|
Contact Name of the ethic committee: |
Li Jie |
||
|
伦理委员会联系地址: |
北京大学医学部逸夫教学楼501室 |
||
|
Contact Address of the ethic committee: |
Room 501, Shaw Teaching Building, Peking University Health Science Center |
||
|
伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 8280 5751 |
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: |
北京大学医学人文学院 |
||||||||||||||||||||||
|
Primary sponsor: |
School of Health Humanities, Peking University |
||||||||||||||||||||||
|
研究实施负责(组长)单位地址: |
北京市海淀区学院路38号 |
||||||||||||||||||||||
|
Primary sponsor's address: |
38 Xueyuan Road, Haidian District, Beijing |
||||||||||||||||||||||
|
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||
|
经费或物资来源: |
北医-OPPO 创新基金 |
||||||||||||||||||||||
|
Source(s) of funding: |
Graduate research project |
||||||||||||||||||||||
|
研究疾病: |
无 |
||||||||||||||||||||||
|
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: |
其它 | ||||||||||||||||||||||
|
Study phase: |
N/A |
||||||||||||||||||||||
|
研究设计: |
随机平行对照 |
||||||||||||||||||||||
|
Study design: |
Parallel |
||||||||||||||||||||||
|
研究目的: |
本研究聚焦职场人士生涯适应对满意度的影响,设计干预方案并评估干预方案的有效性。 |
||||||||||||||||||||||
|
Objectives of Study: |
This study focuses on the impact of career adaptability on satisfaction among working professionals, with the aim of designing an intervention program and evaluating its effectiveness. |
||||||||||||||||||||||
|
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: |
自我报告有严重的躯体或精神疾病。 |
||||||||||||||||||||||
|
Exclusion criteria: |
Self-reported severe physical or psychiatric illness. |
||||||||||||||||||||||
|
研究实施时间: Study execute time: |
从 From 2026-06-10 00:00:00至 To 2026-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-06-10 00:00:00 至 To 2026-12-31 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): |
本研究采用计算机简单随机化方法对被试进行分组。具体而言,在被试完成基线测量后,由研究者使用 R 软件(set.seed() 固定随机种子以确保可重复性)预先生成随机分配序列,按照被试完成基线测量的先后顺序,依次将其分配至干预组或等待控制组,分配比例为 1:1。整个分配过程由计算机自动执行,研究者无法预判或干预分配结果,从而确保分配隐藏。 |
||||||||
|
Randomization Procedure (please state who generates the random number sequence and by what method): |
Following the completion of baseline assessment, participants were randomly assigned to either the intervention group or the waitlist control group at a 1:1 ratio using simple computerized randomization. A random allocation sequence was generated in advance by the researcher using R software, with a fixed random seed (via set.seed()) to ensure reproducibility. Participants were assigned to conditions sequentially according to the order in which they completed the baseline measures. The entire allocation process was executed automatically by the system, preventing the researcher from predicting or influencing group assignments, thereby ensuring allocation concealment. |
||||||||
|
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: |
本研究采用开放标签设计(open-label design),不对被试及结果评估者设盲。在知情同意阶段,所有被试均被告知本研究将采用随机分组方式,可能被分配至干预组或等待控制组。被试在完成基线测量并提交后获知具体分组结果。由于结局指标均通过线上问卷系统收集,结果评估者知晓被试分组情况。为降低由此带来的评估偏倚风险,所有统计分析均依据预先注册的分析方案执行。 |
|
Blinding: |
The present study employed an open-label design; neither participants nor outcome assessors were blinded to group allocation. During the informed consent process, all participants were informed that they would be randomly assigned to either the intervention group or the waitlist control group. Participants were notified of their specific group assignment upon completion and submission of the baseline assessment. As outcome measures were collected via an online survey system, outcome assessors were aware of participants' group assignments. To mitigate the potential risk of assessment bias, all statistical analyses were conducted in accordance with the pre-registered analysis plan. |
|
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): |
因为考虑到患者隐私的保密,我们不共享原始数据,如有需要,可以联系本研究的通讯作者。 |
|
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The sharing of raw data is restricted to protect participant confidentiality, as underscored by our ethical approvals. Researchers may submit a methodologically sound proposal to the corresponding author to request data under a formal data use agreement. |
|
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: |
所有问卷通过问卷星在线收集并存储于其加密服务器。电子知情同意在线完成,仅授权研究成员可访问。 |
|
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The questionnaires were administered online via Wenjuanxing and the collected data were stored on its encrypted servers. Electronic informed consent was obtained online, with access restricted to authorized research members. |
|
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |