ChiCTR2400094247 版本V1.0 版本创建时间2024/12/19 10:00:37 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：

 ChiCTR2400094247 

最近更新日期：

Date of Last Refreshed on：

 2024-12-19 09:59:38 

注册时间：

Date of Registration：

 2024-12-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Efficacy of Online Gamified Pain Management for Adults with Chronic Pain in Mainland China: A Randomized Control Trial

Public title：

Efficacy of Online Gamified Pain Management for Adults with Chronic Pain in Mainland China: A Randomized Control Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Efficacy of Online Gamified Pain Management for Adults with Chronic Pain in Mainland China: A Randomized Control Trial

Scientific title：

Efficacy of Online Gamified Pain Management for Adults with Chronic Pain in Mainland China: 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：

Jiafan He 

研究负责人：

Mimi Mun Yee Tse 

Applicant：

Jiafan He 

Study leader：

Mimi Mun Yee Tse 

申请注册联系人电话：

Applicant telephone：

 +86 151 4267 0120

研究负责人电话：

Study leader's
telephone：

+852 5615 2810

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：

 aquamarine.127@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

 s1350029@live.hkmu.edu.hk

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：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, Hong Kong

研究负责人通讯地址：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, Hong Kong

Applicant address：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, Hong Kong

Study leader's address：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 121000

研究负责人邮政编码：

Study leader's postcode：

 999077

申请人所在单位：

School of Nursing and Health, Hong Kong Metropolitan University

Applicant's institution：

School of Nursing and Health, Hong Kong Metropolitan University

研究负责人所在单位：

School of Nursing and Health, Hong Kong Metropolitan University

Affiliation of the Leader：

School of Nursing and Health, Hong Kong Metropolitan 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：

 HE-SF2024/34

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：

HONG KONG METROPOLITAN UNIVERSITY - Research Ethics Committee (REC)

Name of the ethic committee：

HONG KONG METROPOLITAN UNIVERSITY - Research Ethics Committee (REC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-01 00:00:00

伦理委员会联系人：

Sandy LAM Oi Kwan

Contact Name of the ethic committee：

Sandy LAM Oi Kwan

伦理委员会联系地址：

HONG KONG METROPOLITAN UNIVERSITY - Research Ethics Committee (REC)

Contact Address of the ethic committee：

HONG KONG METROPOLITAN UNIVERSITY - Research Ethics Committee (REC)

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2768 6083

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 soklam@hkmu.edu.hk

研究实施负责（组长）单位：

Hong Kong Metropolitan University

Primary sponsor：

Hong Kong Metropolitan University

研究实施负责（组长）单位地址：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University

Primary sponsor's address：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Hong Kong Metropolitan University

具体地址：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University

Institution
hospital：

Hong Kong Metropolitan University

Address：

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

chronic pain  

Target disease：

chronic pain

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The study aims to develop and examine the effectiveness of the online gamified pain management (GPM) for chronic pain among adults in mainland China. To this end, the objectives will be: 1) examine the effects of the GPM intervention on the levels of pain intensity, pain interference, psychological outcomes and quality of life among adults in mainland China. 2) identify the relationships between the effects of the intervention and socio-demographic factors. 3) explore the perceptions, attitudes and experiences after participating in the intervention.  

Objectives of Study：

The study aims to develop and examine the effectiveness of the online gamified pain management (GPM) for chronic pain among adults in mainland China. To this end, the objectives will be: 1) examine the effects of the GPM intervention on the levels of pain intensity, pain interference, psychological outcomes and quality of life among adults in mainland China. 2) identify the relationships between the effects of the intervention and socio-demographic factors. 3) explore the perceptions, attitudes and experiences after participating in the 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：

1) Aged older than 18 years old 2) Able to read and understand the Mandarin Chinese language 3) Owners of smartphones with internet access 4) Have a previously diagnosed chronic non-cancer pain condition lasting more than three months (Treede et al., 2019) 5) Report a score of ≥2 on the VAS scale

Inclusion criteria

1) Aged older than 18 years old 2) Able to read and understand the Mandarin Chinese language 3) Owners of smartphones with internet access 4) Have a previously diagnosed chronic non-cancer pain condition lasting more than three months (Treede et al., 2019) 5) Report a score of >=2 on the VAS scale

排除标准：

1) Patients with associated pathologies that make it impossible to perform physical exercise (myopathies, neurological diseases, cardiac disease, pregnancy, pulmonary diseases, infection and fracture) 2) Individuals undergoing surgery or invasive treatments in the last three months 3) Concurrent participation (or participation within the preceding 3 months) in a supervised exercise programme or multidisciplinary treatment

Exclusion criteria：

1) Patients with associated pathologies that make it impossible to perform physical exercise (myopathies, neurological diseases, cardiac disease, pregnancy, pulmonary diseases, infection and fracture) 2) Individuals undergoing surgery or invasive treatments in the last three months 3) Concurrent participation (or participation within the preceding 3 months) in a supervised exercise programme or multidisciplinary treatment

研究实施时间：

Study execute time：

从 From 2024-12-31 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-31 00:00:00 至 To 2025-01-31 00:00:00

干预措施：

Interventions：

组别：

Experimental group: Online Gamified pain management (GPM)

样本量：

 110

Group：

Experimental group: Online Gamified pain management (GPM)

Sample size：

干预措施：

The GPM intervention is an 8-week program designed to manage chronic pain by incorporating games, educational information, and progressive exercise. Each week includes two sessions, with each session consisting of a maximum of 15 minutes of game-based and educational content Additionally, participants perform 5 minutes of progressive exercise two to three times per week, with the option to increase exercise duration after meeting the minimum intervention requirements.

干预措施代码：

Intervention：

The GPM intervention is an 8-week program designed to manage chronic pain by incorporating games, educational information, and progressive exercise. Each week includes two sessions, with each session consisting of a maximum of 15 minutes of game-based and educational content Additionally, participants perform 5 minutes of progressive exercise two to three times per week, with the option to increase exercise duration after meeting the minimum intervention requirements.

Intervention code：

组别：

Control group

样本量：

 110

Group：

Control group

Sample size：

干预措施：

The control group will receive routine care. Participants will be provided two leaflets, which includes the same pain educational information involving pain mechanism, effects of chronic pain, pharmacological and non-pharmacological intervention and exercise guidance. The leaflets will be delivered by WeChat, participants are encouraged to read the leaflets and conduct exercises.

干预措施代码：

Intervention：

The control group will receive routine care. Participants will be provided two leaflets, which includes the same pain educational information involving pain mechanism, effects of chronic pain, pharmacological and non-pharmacological intervention and exercise guidance. The leaflets will be delivered by WeChat, participants are encouraged to read the leaflets and conduct exercises.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Hong Kong Metropolitan University 

单位级别：

 大学 

Institution
hospital：

Hong Kong Metropolitan University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Pain intensity

指标类型：

主要指标

Outcome：

Pain intensity

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Pain Catastrophizing

指标类型：

次要指标

Outcome：

Pain Catastrophizing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Adherence

指标类型：

次要指标

Outcome：

Adherence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Depression and Anxiety

指标类型：

次要指标

Outcome：

Depression and Anxiety

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Perception and experiences of the intervention

指标类型：

次要指标

Outcome：

Perception and experiences of the intervention

Type：

Secondary 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：

None

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 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）：

Eligible participants will be randomly assigned to either the GPM intervention (experimental group) or the online handout intervention (control group) using an online randomizer (True Random Number Service) with a 1:1 ratio by a blinded student member who is not involved in study design, assessment or the intervention delivery.

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

Eligible participants will be randomly assigned to either the GPM intervention (experimental group) or the online handout intervention (control group) using an online randomizer (True Random Number Service) with a 1:1 ratio by a blinded student member who is not involved in study design, assessment or the intervention delivery.

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：

All participants will be blinded to their group allocation until the intervention delivered.

Blinding：

All participants will be blinded to their group allocation until the intervention delivered.

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

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）：

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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：

None

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

None

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：

  2024-12-19 09:59:38