ChiCTR2500115876 版本V1.0 版本创建时间2025/12/31 18:02:59 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：

ChiCTR2500115876 

最近更新日期：

Date of Last Refreshed on：

2025-12-31 18:02:44 

注册时间：

Date of Registration：

2025-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

儿童医疗游戏在基层儿科住院患儿中的推广及效果研究

Public title：

Promotion and Effectiveness Research of Child Life (Therapeutic Medical Play) in Hospitalized Children at Primary Care Pediatric Settings

注册题目简写：

English Acronym：

研究课题的正式科学名称：

儿童医疗游戏辅导在儿科住院患儿中的应用实践与循证评估

Scientific title：

Application practice and evidence-based evaluation of children's medical game counseling in pediatric inpatients

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：

周小琴 

研究负责人：

周小琴 

Applicant：

Xiaoqin Zhou 

Study leader：

Xiaoqin Zhou 

申请注册联系人电话：

Applicant telephone：

+86 173 1311 8652

研究负责人电话：

Study leader's telephone：

+86 173 1311 8652

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：

3881191@qq.com

研究负责人电子邮件：

Study leader's E-mail：

3881191@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：

四川省成都市双流区涧槽中街386号

研究负责人通讯地址：

四川省成都市双流区涧槽中街386号

Applicant address：

No. 386, Jiancao Zhongjie, Shuangliu District, Chengdu City, Sichuan Province, China

Study leader's address：

No. 386, Jiancao Zhongjie, Shuangliu District, Chengdu City, Sichuan Province, China

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：

四川省成都市双流区妇幼保健院

Applicant's institution：

Sichuan Province Chengdu City Shuangliu District Maternal and Child Health Hospital

研究负责人所在单位：

四川省成都市双流区妇幼保健院

Affiliation of the Leader：

Sichuan Province Chengdu City Shuangliu District Maternal and Child Health Hospital

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：

[2025]伦审字(ky)-24号

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：

成都市双流区妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Chengdu Shuangliu District Maternal and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-25 00:00:00

伦理委员会联系人：

袁佳英

Contact Name of the ethic committee：

Jiaying Yuan

伦理委员会联系地址：

四川省成都市双流区涧槽中街386号

Contact Address of the ethic committee：

No. 386, Jiancao Zhongjie, Shuangliu District, Chengdu City, Sichuan Province, China?

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 181 8069 7116

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：

四川省成都市双流区妇幼保健院

Primary sponsor：

Sichuan Province Chengdu City Shuangliu District Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

四川省成都市双流区涧槽中街386号

Primary sponsor's address：

No. 386, Jiancao Zhongjie, Shuangliu District, Chengdu City, Sichuan Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川省成都市双流区妇幼保健院

具体地址：

成都市双流区涧槽中街386号

Institution
hospital：

Chengdu Shuangliu District Maternal and Child Health Hospital

Address：

No. 386, Jiancao Zhongjie, Shuangliu District, Chengdu City, Sichuan Province, China

经费或物资来源：

四川省妇幼保健协会科研课题（编号2025FX10）资助和单位配套经费

Source(s) of funding：

Supported by the Sichuan Provincial Maternal and Child Health Care Association Scientific Research Project (Grant No. 2025FX10) and unit matching funds

Target disease：

Pediatric bronchopneumonia, acute bronchitis

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：

本研究依据2024年版《儿童友好医院建设指南》中关于“就医环境友好”和“健康服务友好”的条款，针对儿科住院患儿在医疗环境中可能遇到的恐惧和焦虑问题，以儿童友好医疗的核心原则（包括儿童参与、情感支持和家庭中心照护）为理论基础，科学地设计并实施了结构化的医疗游戏干预措施，系统地评估儿童医疗游戏在儿科住院部的规范化实践及效果评估。 研究目标具体包括：①显著降低住院患儿的恐惧与焦虑水平；②有效提升患儿在诊疗操作（尤其是侵入性操作及检查）及日常治疗（如服药、雾化）中的依从性；③改善患儿家属的就医体验感知与满意度；④促进医护人员对儿童友好理念及游戏辅导技能的掌握与应用能力。最终，基于循证评估结果，构建一套本土化、可推广的儿科住院部儿童医疗游戏规范化服务方案与操作指南，为优化患儿就医体验、提升儿科服务质量、推动儿童友好医院建设中“游戏辅导”服务的专业化与标准化进程提供科学依据和实践路径。  

Objectives of Study：

Based on the provisions of the 2024 Edition of the Guidelines for the Construction of Child-Friendly Hospitals regarding 'Friendly Medical Environment' and 'Friendly Health Services', this study addresses the fear and anxiety that pediatric inpatients may encounter in medical settings. Grounded in the core principles of child-friendly healthcare (including child participation, emotional support, and family-centered care), the research scientifically designed and implemented structured medical play interventions. It systematically evaluated the standardized practice and effectiveness of children's medical play in pediatric inpatient departments. The specific research objectives include:1. Significantly reducing the fear and anxiety levels of hospitalized children;2. Effectively improving children's compliance during medical procedures (especially invasive procedures and examinations) and daily treatments (such as medication administration and nebulization); 3. Enhancing the perceived medical experience and satisfaction of children's families; 4.Promoting healthcare providers' mastery and application of child-friendly concepts and play guidance skills. Ultimately, based on evidence-based evaluation results, a localized, promotable standardized service plan and operational guidelines for children's medical play in pediatric inpatient departments will be constructed. This will provide a scientific basis and practical path for optimizing children's medical experience, improving pediatric service quality, and advancing the professionalization and standardization of 'play guidance' services in the construction of child-friendly hospitals.

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.医院儿科住院部办理入院的需要治疗的患儿； 2.患儿意识清醒，能正常沟通； 3.患儿监护人已充分了解研究内容并签署书面知情同意书； 4.符合《儿童社区获得性肺炎诊疗规范（2019年版）》中关于支气管肺炎或急性支气管炎的诊断标准，且经临床评估确需住院治疗。

Inclusion criteria

1. the pediatric inpatient department of the hospital handles the hospitalized children who need treatment; 2. the child is conscious and can communicate normally; 3. the child's guardian has fully understood the research content and signed the written informed consent; 4. it meets the diagnostic criteria for bronchopneumonia or acute bronchitis in the code for the diagnosis and treatment of community acquired pneumonia in children (2019 version), and it is indeed necessary to be hospitalized after clinical evaluation.

排除标准：

1.严重基础疾病：排除患有严重心肺功能障碍、肾功能不全等基础疾病的患儿。 2.急腹症（如高热抽搐、肠套叠、肠梗阻、急性胃肠炎、急性肠系膜淋巴结炎等）。 3.精神或心理障碍：排除患有严重精神或心理障碍的患儿，如精神分裂症、重度抑郁症等。 4.免疫功能低下或传染病：排除免疫功能低下或患有传染性疾病的患儿，以避免在医疗辅导过程中出现交叉感染或其他并发症，保障患儿的安全。 5.家长或患儿拒绝参与研究。 6.已纳入并分组，但因各种原因（家属放弃等）未按规定完成治疗的观察者。 7.观察者发生严重不良事件或反应，临床研究过程中出现严重的其他并发疾病或病情恶化，不宜继续接受试验者。 8.资料不全，无法判断疗效者。不予合作，自行退出者。

Exclusion criteria：

1. Severe underlying diseases: Exclude children with underlying conditions such as severe cardiorespiratory dysfunction, renal insufficiency, etc. 2. Acute abdomen (e.g., high fever convulsions, intussusception, intestinal obstruction, acute gastroenteritis, acute mesenteric lymphadenitis, etc.). 3. Mental or psychological disorders: Exclude children with severe mental or psychological disorders, such as schizophrenia, severe depression, etc. 4. Immunodeficiency or infectious diseases: Exclude children with immunodeficiency or infectious diseases to avoid cross-infection or other complications during medical guidance and ensure the safety of the children. 5. Parents or children refuse to participate in the study. 6. Observers who have been included and grouped but failed to complete treatment as required for various reasons (e.g., family withdrawal). 7. Observers who experience serious adverse events or reactions, develop other serious concurrent diseases, or have deteriorating conditions during clinical research, making it unsuitable for them to continue with the trial. 8. Observers with incomplete data that cannot be used to judge efficacy; observers who do not cooperate or withdraw on their own.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-06-30 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

120

Group：

Control group

Sample size：

干预措施：

对照组患儿将接受常规的诊疗和护理，不包括儿童医疗游戏服务。

干预措施代码：

Intervention：

The control group children will receive routine diagnosis, treatment, and nursing care, excluding pediatric medical play services.

Intervention code：

组别：

试验组

样本量：

120

Group：

Experimental group

Sample size：

干预措施：

试验组患儿在接受常规诊疗和护理服务的同时将接受儿童医疗游戏服务。

干预措施代码：

Intervention：

While receiving routine medical treatment and nursing services, the children in the experimental group will also receive children's medical play services.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

 成都市 

Country：

China 

Province：

Sichuan 

City：

Chengdu  

单位(医院)：

成都市双流区妇幼保健院 

单位级别：

三甲 

Institution
hospital：

Chengdu Shuangliu District Maternal and Child Health Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

儿童焦虑性情绪障碍筛查表得分

指标类型：

主要指标

Outcome：

SCARED,Score of children's anxiety mood disorder screening form

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童医疗恐惧量表

指标类型：

主要指标

Outcome：

CMFS,Children's medical fear scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童治疗依从性观察量表

指标类型：

主要指标

Outcome：

Pediatric Treatment Compliance Observation Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童睡眠紊乱量表

指标类型：

次要指标

Outcome：

SDSC,Children's sleep disorder scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院期间患儿家长满意度

指标类型：

次要指标

Outcome：

Parents' satisfaction during hospitalization

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

评估患儿疼痛

指标类型：

次要指标

Outcome：

Wong-Bake

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：

无

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 岁 years
最大 Max age 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）：

参与研究的病房按照1:1比例，随机分配至干预组或对照组（常规处理）。随机序列由与试验实施无关的独立统计师使用计算机随机数表生成，分配方案封存于按顺序编号的不透明密封信封中，由试验实施护士在所有参与病房确定后依次启封。一旦某一病房完成随机分配，该病房在研究期间内所有符合纳入标准并签署知情同意的患者，均接受该病房所对应的干预或常规处理；因此，个体患者并不单独随机，而是继承其所在病房的分组，从而减少同一病房内不同处理之间的干预污染。

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

The wards participating in the study were randomly assigned in a 1:1 ratio to either the intervention group or the control group (routine care). The random sequence was generated by an independent statistician using a computer-generated random number table, unrelated to the implementation of the trial. The allocation scheme was sealed in sequentially numbered opaque envelopes, which were opened by the trial implementation nurses one by one after all participating wards were determined. Once a ward completed random assignment, all patients in that ward during the study period who met the inclusion criteria and signed informed consent received either the intervention corresponding to the ward or routine care; therefore, individual patients were not randomized separately but inherited the group assignment of their ward, thereby reducing intervention contamination between different treatments within the same ward.

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：

为减少评估偏倚，本研究设立了独立的评估环节。所有问卷类结局指标（如SCARED、CMFS、治疗依从性、睡眠紊乱及家长满意度）的收集工作，均由不知晓分组信息的研究助理采用单盲法完成。唯一例外的是针对侵入性操作（如静脉留置针穿刺、皮试）的疼痛评估，该指标需由执行操作的治疗护士在操作前后即刻完成。

Blinding：

To minimize assessment bias, an independent evaluation procedure was established. All questionnaire-based outcome measures—including the Screen for Child Anxiety Related Emotional Disorders (SCARED), the Children's To reduce assessment bias, this study established an independent evaluation phase. The collection of all questionnaire-based outcome measures (such as SCARED, CMFS, treatment compliance, sleep disturbances, and parental satisfaction) was conducted by research assistants who were unaware of the group allocation using a single-blind method. The only exception was the pain assessment for invasive procedures (such as intravenous cannulation and skin tests), which required the treating nurse to complete immediately before and after the procedure.

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）：

根据需要联系项目负责人，可以提供相关数据。

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

Please contact the project leader as needed to obtain relevant data.

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：

一部分数据通过问卷调查获取，一部分从电子病历提取，最后形成数据库。

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

Some of the data was obtained through questionnaires, and some was extracted from electronic medical records, finally forming a database.

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：

  2025-12-31 18:02:44