ChiCTR2500103568 版本V1.0 版本创建时间2025/05/30 16:12:49 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:

ChiCTR2500103568 

最近更新日期:

Date of Last Refreshed on:

2025-05-30 16:12:45 

注册时间:

Date of Registration:

2025-05-30 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

正念对城市公园游客心理幸福感的影响:来自三项实验研究的证据

Public title:

The Effects of Mindfulness on Psychological Thriving among Urban Park Visitors: Evidence from Three Experimental Studies.

注册题目简写:

English Acronym:

研究课题的正式科学名称:

正念对城市公园游客心理幸福感的影响:来自三项实验研究的证据

Scientific title:

The Effects of Mindfulness on Psychological Thriving among Urban Park Visitors: Evidence from Three Experimental Studies.

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:

芮唱 

研究负责人:

芮唱 

Applicant:

Rui Chang 

Study leader:

Rui Chang 

申请注册联系人电话:

Applicant telephone:

+86 198 1080 0708

研究负责人电话:

Study leader's telephone:

+86 198 1080 0708

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:

454039345@qq.com

研究负责人电子邮件:

Study leader's E-mail:

454039345@qq.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:

安徽省淮南市田家庵区洞山西路 33 号

研究负责人通讯地址:

安徽省淮南市田家庵区洞山西路 33 号

Applicant address:

No. 33, Dongshan West Road, Tianjia'an District, Huainan City, Anhui Province

Study leader's address:

No. 33, Dongshan West Road, Tianjia'an District, Huainan City, Anhui 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:

淮南师范学院

Applicant's institution:

Huainan Normal University

研究负责人所在单位:

淮南师范学院

Affiliation of the Leader:

Huainan Normal University

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

无独立伦理批件,由淮南师范学院学术委员会合并完成伦理审核(见附件审查批件)

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:

淮南师范学院学术委员会

Name of the ethic committee:

Academic Committee of Huainan Normal University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-05-29 00:00:00

伦理委员会联系人:

方曙光

Contact Name of the ethic committee:

Shuguang Fang

伦理委员会联系地址:

安徽省淮南市田家庵区洞山西路 33 号

Contact Address of the ethic committee:

No. 33, Dongshan West Road, Tianjia'an District, Huainan City, Anhui Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 138 5548 3930

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:

淮南师范学院

Primary sponsor:

Huainan Normal University

研究实施负责(组长)单位地址:

安徽省淮南市田家庵区洞山西路 33 号

Primary sponsor's address:

No. 33, Dongshan West Road, Tianjia'an District, Huainan City, Anhui Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

安徽省

市(区县):

田家庵区

Country:

China

Province:

Anhui Province

City:

单位(医院):

淮南师范学院

具体地址:

安徽省淮南市田家庵区洞山西路 33 号

Institution
hospital:

Huainan Normal University

Address:

No. 33, Dongshan West Road, Tianjia'an District, Huainan City, Anhui Province

经费或物资来源:

自筹资金

Source(s) of funding:

Self-funded

Target disease:

None

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:

比较不同正念训练形式的效果:探讨数字正念训练与传统正念训练对城市公园游客心理幸福感(Thriving)的影响差异。 揭示心理机制:验证毅力(Perseverance)和生命意义感(Sense of life meaning)在正念训练形式与心理幸福感之间的链式中介作用。 明确边界条件:考察身体欣赏(Body Appreciation)对正念训练形式与心理幸福感关系的调节作用。  

Objectives of Study:

Comparison of the Effects of Different Mindfulness Training Formats This study explores the differences in the effects of digital mindfulness training and traditional mindfulness training on the psychological well-being (Thriving) of urban park visitors. Revealing Psychological Mechanisms It validates the serial mediating role of perseverance and sense of life meaning in the relationship between mindfulness training formats and psychological well-being (Thriving). Specifically, it examines how these two factors sequentially mediate the impact of training formats on Thriving. Clarifying Boundary Conditions This research investigates the moderating role of body appreciation in the relationship between mindfulness training formats and psychological well-being (Thriving). It aims to determine how individual levels of body appreciation influence the effectiveness of different training formats on Thriving.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1、年龄与行为能力 参与者须年满 18 周岁,具备完全民事行为能力,能够独立理解研究流程并签署知情同意书,符合成年人群的心理研究基本要求。 2、城市公园使用经验 实验 1–2(线上):参与者需在过去 1 个月内至少访问过 1 次城市公园(含湿地公园),以确保其对研究聚焦的 “城市湿地公园” 自然场景有基本认知,符合实验中虚拟正念训练的场景预设。 实验 3(现场):参与者需在招募时位于城市 A 湿地公园内,且过去 1 周内有公园游览经历,以强化现场实验中 “沉浸式环境互动” 的生态效度(论文实验 3 描述为 “in-person experiment”)。 3、数字设备操作能力 实验 1–2:需熟练使用智能手机或电脑,以完成线上问卷填写及虚拟正念训练(论文中数字组干预通过 “AI 语音引导的移动端程序” 实施,需参与者具备基础设备操作能力)。 实验 3:愿意配合使用研究团队提供的手机完成数字正念训练(传统组接受志愿者现场指导),无需额外技术门槛,适应现场实验的便捷性要求。 4、心理健康状态 通过简易心理筛查排除严重精神疾病史(如采用 K10 量表筛查,总分≤16 分)。尽管论文未明确临床排除标准,但为避免极端心理状态干扰数据有效性,需排除可能影响正念训练效果或量表作答的个体。 5、语言与文化背景 母语为中文或能流利使用中文,确保参与者理解中文版本的量表与指导语(论文样本为国内城市公园游客,语言环境以中文为核心)。 6、实验分组适配性 所有参与者通过随机抽样分配至数字正念训练组或传统正念训练组,符合论文中 “随机分组” 的实验设计原则。

Inclusion criteria

1. Age and Legal Capacity Participants must be at least 18 years old and possess full civil capacity to independently understand study procedures and sign the informed consent form, meeting the basic requirements for psychological research on adult populations. 2. Urban Park Experience Online Experiments (1–2): Participants must have visited an urban park (including wetland parks) at least once in the past month to ensure familiarity with the "urban wetland park" natural scenes focused in the study, aligning with the scenario presets of virtual mindfulness training in the experiments. On-Site Experiment (3): Participants must be physically present in City A’s wetland park at the time of recruitment and have visited a park within the past week to enhance the ecological validity of "immersive environmental interaction" in the on-site experiment (Experiment 3 in the paper is described as an "in-person experiment"). 3. Digital Device Proficiency -Online Experiments (1–2): Proficiency in using smartphones or computers is required to complete online questionnaires and virtual mindfulness training (the digital group intervention in the paper is implemented via an "AI voice-guided mobile application," requiring participants to have basic device operation capabilities). -On-Site Experiment (3): Willingness to use mobile phones provided by the research team to complete digital mindfulness training (the traditional group receives on-site guidance from volunteers), with no additional technical barriers, adapting to the convenience requirements of on-site experiments. 4. Mental Health Status Severe mental illness history is excluded through simple psychological screening (e.g., screening with the K10 scale, total score ≤ 16). Although the paper does not explicitly state clinical exclusion criteria, individuals who may affect the effectiveness of mindfulness training or scale responses are excluded to avoid data validity interference from extreme psychological states. 5. Language and Cultural Background Participants must be native Chinese speakers or fluent in Chinese to ensure they can understand the Chinese versions of the scales and instructions (the paper’s samples are domestic urban park visitors, with Chinese as the core language environment). 6. Experimental Group Allocation Compatibility All participants are assigned to either the digital mindfulness training group or the traditional mindfulness training group through random sampling, adhering to the "random grouping" experimental design principle in the paper.

排除标准:

1、年龄不符合要求:未满 18 周岁或无法提供有效身份证明以证明具备完全民事行为能力者。 2、城市公园使用经验不足: 实验 1-2(线上):过去 1 个月内未访问过任何城市公园(含湿地公园)者。 实验 3(现场):招募时不在城市 A 湿地公园内,或过去 1 周内无公园游览经历者。 3、数字设备操作障碍: 实验 1-2:无法熟练使用智能手机或电脑完成线上问卷及虚拟正念训练(如因视力、听力障碍或技术能力不足导致无法配合)。 实验 3:拒绝使用研究团队提供的手机完成数字正念训练,且无法参与传统组现场指导者。 4、心理健康风险: 经简易心理筛查(如 K10 量表总分 > 16 分)或自我报告显示存在严重精神疾病史(如抑郁症、焦虑症急性发作期、精神分裂症等)者。 正接受精神科药物治疗或心理咨询,可能影响正念训练效果或心理量表测量准确性者。 5.语言障碍:无法理解中文量表或指导语,且无法通过翻译辅助完成研究者。 6、实验流程不配合:拒绝签署知情同意书,或在实验过程中拒绝完成关键任务(如正念训练、问卷填写)者。 7、注意力检查未通过:在实验前测或过程中未能通过注意力筛查任务(如随机插入的无效题项回答错误率过高),可能导致数据无效者。

Exclusion criteria:

1.Ineligible Age or Legal Capacity Participants under 18 years of age or unable to provide valid identification to demonstrate full civil capacity. 2.Insufficient Urban Park Experience Online Experiments (1–2): Participants who have not visited any urban park (including wetland parks) in the past month. On-Site Experiment (3): Participants not physically present in City A’s wetland park at recruitment or without a park visit within the past week. 3.Digital Device Operational Barriers Online Experiments (1–2): Inability to use smartphones or computers proficiently to complete online questionnaires and virtual mindfulness training (e.g., due to visual/hearing impairments or technical incompetence). On-Site Experiment (3): Refusal to use research-provided smartphones for digital mindfulness training and inability to participate in live-guided traditional group sessions. 4.Mental Health Risks Participants with positive screening for severe mental illness history via brief psychological assessment (e.g., K10 scale total score > 16) or self-reported history (e.g., acute depression/anxiety episodes, schizophrenia). Individuals currently undergoing psychiatric medication or counseling that may interfere with mindfulness training efficacy or psychological scale accuracy. 5.Language Barriers Inability to understand Chinese scales/instructions and inability to complete the study with translation assistance. 6.Non-Compliance with Procedures Refusal to sign the informed consent form. Refusal to complete key tasks (e.g., mindfulness training, questionnaire administration) during the experiment. 7.Failed Attention Checks Participants who fail attention screening tasks (e.g., excessively high error rates on randomly inserted invalid items) during pre-testing or the experiment, potentially compromising data validity..

研究实施时间:

Study execute time:

From 2025-06-01 00:00:00 To 2025-06-20 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-06-04 00:00:00 To 2025-06-20 00:00:00  

干预措施:

Interventions:

组别:

数字正念训练组

样本量:

307

Group:

Digital Mindfulness Training Group

Sample size:

干预措施:

数字正念训练:参与者使用专门设计的手机应用程序进行正念训练,程序包含引导语、冥想音频等内容,在城市公园场景中引导参与者进行 15 分钟的正念练习。

干预措施代码:

Intervention:

Digital Mindfulness Training: Participants engage in mindfulness training using a specially - designed mobile app. The app contains guiding instructions and meditation audios, and it leads participants through a 15 - minute mindfulness practice session in the urban park setting.

Intervention code:

组别:

传统正念训练组

样本量:

306

Group:

Traditional Mindfulness Training Group

Sample size:

干预措施:

传统正念训练:由专业指导人员现场带领,通过口头引导的方式,在城市公园场景中进行 15 分钟的正念冥想练习。

干预措施代码:

Intervention:

Traditional Mindfulness Training: Led on - site by professional instructors, participants conduct a 15 - minute mindfulness meditation practice through verbal guidance in the urban park setting.

Intervention code:

组别:

无干预对照组

样本量:

306

Group:

Non - intervention Control Group

Sample size:

干预措施:

无干预:对照组在城市公园中自由活动 15 分钟,不接受任何正念训练干预。

干预措施代码:

Intervention:

No Intervention: The control group freely moves around in the urban park for 15 minutes without receiving any mindfulness training intervention.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui Province 

City:

 

单位(医院):

淮南城市湿地公园 

单位级别:

无 N/A 

Institution
hospital:

Huainan Urban Wetland Park

Level of the institution:

no administrative level

测量指标:

Outcomes:

指标中文名:

心理幸福感

指标类型:

主要指标

Outcome:

Psychological Thriving

Type:

Primary indicator

测量时间点:

实验 1 - 3 干预后立即测量

测量方法:

使用综合蓬勃发展量表(CIT),采用 7 点 Likert 量表(1 = 强烈不同意,7 = 强烈同意 )

Measure time point of outcome:

Measure method:

指标中文名:

毅力

指标类型:

主要指标

Outcome:

Perseverance

Type:

Primary indicator

测量时间点:

实验 2 - 3 干预后立即测量

测量方法:

使用毅力量表(Grit Scale),采用 7 点 Likert 量表(1 = 强烈不同意,7 = 强烈同意 )

Measure time point of outcome:

Measure method:

指标中文名:

生命意义感

指标类型:

主要指标

Outcome:

Sense of Life Meaning

Type:

Primary indicator

测量时间点:

实验 2 - 3 干预后立即测量

测量方法:

使用生命意义问卷(MLQ),采用 7 点 Likert 量表(1 = 强烈不同意,7 = 强烈同意 )

Measure time point of outcome:

Measure method:

指标中文名:

身体欣赏

指标类型:

主要指标

Outcome:

Body Appreciation

Type:

Primary indicator

测量时间点:

实验 3 干预后立即测量

测量方法:

使用身体欣赏量表(BAS - 2),采用 7 点 Likert 量表(1 = 强烈不同意,7 = 强烈同意

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:

None

Tissue:

None

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

None

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 years
最大 Max age 70 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):

由研究人员使用专业统计软件(如 SPSS )中的随机数生成功能,将符合纳入标准的参与者随机分配至数字正念训练组、传统正念训练组和无干预对照组。

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

Researchers use the random number generation function in professional statistical software (such as SPSS) to randomly assign participants who meet the inclusion criteria to the Digital Mindfulness Training Group, Traditional Mindfulness Training Group, and Non - intervention Control 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:

双盲

Blinding:

Double blinded

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

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):

计划在研究论文发表后的 3个月,通过开放获取的数据存储库Figshare共享原始数据。在共享时,将同时提供元数据和研究方案,以便其他研究人员理解数据内容和研究背景。

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

The raw data will be shared via the open - access data repository Figshare three months after the publication of the research paper. Metadata and the research protocol will be provided simultaneously to enable other researchers to understand the data content and research context.

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(Case Record Form, CRF):设计了专门的问卷,用于收集游客的基本信息(如年龄、性别、教育程度等)、正念训练前后的心理状态数据(包含心理蓬勃发展水平、毅力、生命意义感、身体欣赏等相关量表得分 )。问卷在实验干预前后由游客现场填写或通过线上平台填写,确保信息准确、完整。 电子采集和管理系统(Electronic Data Capture, EDC):采用 Credamo 平台进行线上数据采集。该平台具备数据实时录入、逻辑校验等功能,可有效避免数据录入错误。数据收集后,通过加密技术存储于安全服务器,由研究团队专人负责管理,定期进行备份,以保障数据的安全性和完整性。

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

For this study, data collection and management are carried out as follows: Case Record Form (CRF): Specialized questionnaires are designed to collect visitors' basic information (such as age, gender, educational level, etc.) and psychological state data before and after mindfulness training (including scores from scales related to psychological thriving, perseverance, sense of life meaning, body appreciation, etc.). The questionnaires are filled out by visitors on - site or through an online platform before and after the experimental intervention to ensure accurate and complete information. Electronic Data Capture (EDC): The Credamo platform is used for online data collection. This platform has functions such as real - time data entry and logical verification, which can effectively prevent data entry errors. After data collection, the data are stored on a secure server using encryption technology. A dedicated person from the research team is responsible for management, and regular backups are made to ensure the security and integrity of the data.

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:

 2025-05-30 16:12:45