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Factors Influencing Parents' Readiness for Hospital Discharge in Children Under Five with Severe Pneumonia

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注册号：

Registration number：

ChiCTR2500115306 

最近更新日期：

Date of Last Refreshed on：

2025-12-24 16:03:18 

注册时间：

Date of Registration：

2025-12-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

影响五岁以下重症肺炎患儿家长出院准备度的相关因素

Public title：

Factors Influencing Parents' Readiness for Hospital Discharge in Children Under Five with Severe Pneumonia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

影响五岁以下重症肺炎患儿家长出院准备度的相关因素

Scientific title：

Factors Influencing Parents' Readiness for Hospital Discharge in Children Under Five with Severe Pneumonia

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：

张双红 

研究负责人：

张双红 

Applicant：

Shuanghong Zhang 

Study leader：

Shuanghong Zhang 

申请注册联系人电话：

Applicant telephone：

+86 13736391537

研究负责人电话：

Study leader's telephone：

+86 577 88002715

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：

zshsandy@163.com

研究负责人电子邮件：

Study leader's E-mail：

zshsandy@163.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：

浙江省温州市龙湾区温州大道(东段)1111号

研究负责人通讯地址：

浙江省温州市龙湾区温州大道(东段)1111号

Applicant address：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang Province

Study leader's address：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang 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：

温州医科大学附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属第二医院

Affiliation of the Leader：

The Second Affiliated Hospital of Wenzhou Medical 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：

伦审（2025-K-420-01）

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：

温州医科大学附属第二医院 温州医科大学附属育英儿童医院医学伦理委员会

Name of the ethic committee：

Research Ethics Committee of of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-18 00:00:00

伦理委员会联系人：

陈苑

Contact Name of the ethic committee：

Chen Yuan

伦理委员会联系地址：

浙江省温州市龙湾区温州大道(东段)1111号

Contact Address of the ethic committee：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 577 85676879

伦理委员会联系人邮箱：

Contact email of the ethic committee：

feykjkcy@126.com

研究实施负责（组长）单位：

温州医科大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市龙湾区温州大道(东段)1111号

Primary sponsor's address：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属第二医院

具体地址：

浙江省温州市龙湾区温州大道(东段)1111号

Institution
hospital：

The Second Affiliated Hospital of Wenzhou Medical University

Address：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-paying

Target disease：

Community-acquired severe pneumonia

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

1.描述5岁以下重症肺炎患儿家长的出院准备度水平。 2.探讨儿童疾病严重程度、父母压力、父母自我效能、家庭支持、出院指导质量、家庭收入和父母教育程度如何影响5岁以下重症肺炎患儿家长的出院准备度。  

Objectives of Study：

1.To describe the parent’s readiness for hospital discharge among children under five years old with severe pneumonia.2.To examine the severity of the child's illness, parenting stress, parental self-efficacy, family support, quality of discharge teaching, family income, and Parental educational attainment influencing the parent’s readiness for hospital discharge among children under five years old with severe pneumonia.

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.家长年龄≥18周岁。
2.家长为患儿的主要照顾者，满足以下条件之一： 在普通病房住院期间：家长在本次住院期间提供至少48小时的照护； 从PICU转入普通病房：在PICU期间参与所有允许的探视时间的80%以上，转入普通病房后提供陪护时间≥普通病房住院时间的80%； 仅在PICU住院：参与所有允许的探视时间的80%以上，并将在出院后承担主要照护责任。
3.家长具备中文阅读和交流能力。
4.有5岁以下被诊断为重症社区获得性肺炎并住院至少48小时的子女。

Inclusion criteria

1.Parents is 18 years old or older; 2. Parents are the primary caregivers for the child patients, meeting one of the following conditions: During hospitalization in general wards: Parents provide at least 48 hours of care during the current hospitalization; When transferred from PICU to general ward: Parents participated in more than 80% of all permitted visiting hours during the PICU stay, and provided companionship time >= 80% of the general ward hospitalization time after transfer; For patients hospitalized only in the PICU: Parents participated in more than 80% of all permitted visiting hours, and will assume primary caregiving responsibilities after discharge; 3. Parents have the ability to read and communicate in Chinese; 4. Have children under five years old diagnosed with severe community-acquired pneumonia and hospitalized for at least 48 hours.4. Have children under five years old diagnosed with severe community-acquired pneumonia and hospitalized for at least 48 hours.

排除标准：

1.家长被诊断患有严重的身体或精神疾病，影响问卷完成能力。
2．家长有听力、视力或认知障碍，无法独立交流。
3．患儿患有严重先天性心脏病、神经肌肉疾病、免疫缺陷或慢性肺部疾病。
4.转院、自动出院及其他非计划性出院病例。

Exclusion criteria：

1. Parents has been diagnosed with severe physical or mental illness that affects the completion of the questionnaire;
2. Parents has hearing, vision, or cognitive disabilities that prevent independent communication;
3. The child has severe congenital heart disease, neuromuscular disease, immune deficiency, or chronic lung disease;
4.Cases of transfer to another hospital, automatic discharge and other unplanned discharges.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-03-31 00:00:00  

干预措施：

Interventions：

组别：

观察组

样本量：

184

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

温州医科大学附属第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

父母受教育程度

指标类型：

次要指标

Outcome：

Parental educational attainment（highest formal education of parents）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

通过自编《人口学与家庭特征问卷》询问父亲和母亲的最高学历，分为：初中及以下、高中/大专、本科、研究生及以上等等级，并可根据需要计算“父母最高学历”或分别纳入分析。学历越高通常意味着健康素养和信息理解能力越好。

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

Educational attainment of both parents was assessed using a self-designed Demographic and Family Characteristics Questionnaire, which categorized the highest education levels into: junior high school or below, high school/vocational college, bachelor's degree, and postgraduate degree or above. Depending on analytical requirements, either the "highest parental education level" may be computed or maternal and paternal education levels may be incorporated separately into analyses. Higher educationa

指标中文名：

父母养育压力

指标类型：

次要指标

Outcome：

Parenting stress（Chinese Parenting Stress Index/Short Form, C?PSI/SF）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

采用中文版《养育压力量表–简表》（Chinese Parenting Stress Index/Short Form, C?PSI/SF），共 36 个条目，包含“父母困扰、亲子互动功能失调、困难儿童”3 个维度，每题 1～5 分，总分 36～180 分。 ＜85 分为正常水平，86–90 分为临界高水平，91–98 分为高水平，＞99 分为极高水平，总分越高表示父母在养育患儿过程中承受的心理应激

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

The study utilized the Chinese Parenting Stress Index/Short Form (C?PSI/SF), which comprises 36 items spanning three dimensions: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each item is scored on a 1–5 point scale, yielding a total score range of 36–180. Scores below 85 are classified as normal, 86–90 as borderline high, 91–98 as high, and above 99 as clinically significant. Higher total scores indicate greater psychological stress experienced by parents in

指标中文名：

家庭支持

指标类型：

次要指标

Outcome：

Family support（family subscale of Multidimensional Scale of Perceived Social Support, SPSS）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

采用中文版《感知社会支持量表》（Scale of Perceived Social Support, SPSS/MSPSS）的“家庭支持”维度，共 4 个条目，每题 1～7 分，总分 4～28 分。 4–11 分为低支持，12–19 分为中等支持，20–28 分为高支持，得分越高表示父母感受到的家庭情感支持和工具性支持越充分。

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

The "Family Support" subscale of the Chinese version of the Scale of Perceived Social Support (SPSS) was utilized, comprising four items. Each item is rated on a 7-point Likert scale (1-7), yielding a total score range of 4–28. Scores of 4–11 indicate low support, 12–19 indicate moderate support, and 20–28 indicate high support. Higher scores reflect greater perceived family emotional and instrumental support by parents.

指标中文名：

父母出院准备度总分

指标类型：

主要指标

Outcome：

Parent Readiness for Hospital Discharge score（C?RHDS?Parent Form ）

Type：

Primary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

使用中文版《住院出院准备度量表–父母版》（Chinese version of Readiness for Hospital Discharge Scale?Parent Form，C?RHDS?Parent Form）进行自填问卷评估，共 22 个条目，分为知识、身心状况、预期支持和疼痛状况 4 个维度。 每题 0～10 分，计算总分（0～220 分），得分越高表示父母对儿童出院后的照护准备度越

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

The self-administered questionnaire assessment was conducted using the Chinese version of the Readiness for Hospital Discharge Scale - Parent Form (C-RHDS-Parent Form), which consists of 22 items and is divided into four dimensions: knowledge, physical and mental condition, expected support, and pain condition. Each item is scored from 0 to 10, and the total score (0 to 220) is calculated. The higher the score, the higher the parents' readiness for caring for their children after discharge.

指标中文名：

家庭收入

指标类型：

次要指标

Outcome：

Family monthly income（self?reported household income）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

通过自编《人口学与家庭特征问卷》收集家庭经济状况，包括夫妻个人收入和家庭月总收入等。家庭月收入按人民币分档，用于反映家庭可支配经济资源水平。

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

Data on household economic status, including individual income of both spouses and total monthly household income, were collected using the self-designed Demography and Family Characteristics Questionnaire. Monthly household income was categorized into ranges in Chinese yuan to reflect the level of disposable economic resources available to the household.

指标中文名：

儿童疾病严重程度

指标类型：

次要指标

Outcome：

Severity of child’s illness（Pediatric Risk of Mortality Score III, PRISM III）

Type：

Secondary indicator

测量时间点：

入院后前 24 小时内，依据病历中记录的最异常生命体征和实验室指标计算 1 次

测量方法：

采用《儿童死亡风险评分量表 第三版》（Pediatric Risk of Mortality Score III, PRISM III）。 根据患儿入院后 24 小时内最异常的 17 项生理指标（血压、心率、体温、呼吸状况、血气、电解质、肝肾功能、凝血等）进行评分，总分 0–75 分，分值越高表示病情越重、死亡风险越高。

Measure time point of outcome：

Within the first 24 hours after admission, calculate once based on the most abnormal vital signs and

Measure method：

The Pediatric Risk of Mortality Score III (PRISM III) was employed for assessment. Evaluation was conducted based on the most abnormal values of 17 physiological parameters (including blood pressure, heart rate, body temperature, respiratory status, blood gas analysis, electrolytes, hepatic and renal function, coagulation profiles, etc.) recorded within the first 24 hours of hospital admission. The total score ranges from 0 to 75, with higher scores indicating greater severity of illness and e

指标中文名：

出院宣教质量

指标类型：

次要指标

Outcome：

Quality of discharge teaching（Chinese Quality of Discharge Teaching Scale, C?QDTS）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

采用中文版《出院宣教质量量表》（Chinese Quality of Discharge Teaching Scale, C?QDTS），共 18 个条目，分为“获得的内容”和“宣教方式”2 个维度，每题 0～10 分，总分 0–180 分。 0–36 分为极低，37–72 分为较低，73–108 分为中等，109–144 分为较高，145–180 分为极高，得分越高说明家长感知的出院宣教内容越全

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

The study employed the Chinese version of the Quality of Discharge Teaching Scale (C-QDTS), which comprises 18 items categorized into two dimensions: "Content Received" and "Teaching Delivery Method." Each item is scored on a scale of 0 to 10, yielding a total score ranging from 0 to 180. Scores are interpreted as follows: 0–36 indicates an extremely low level, 37–72 a relatively low level, 73–108 a moderate level, 109–144 a relatively high level, and 145–180 an extremely high level. Higher scor

指标中文名：

父母自我效能

指标类型：

次要指标

Outcome：

Parental self-efficacy（Chinese General Self?Efficacy Scale, C?GSES）

Type：

Secondary indicator

测量时间点：

计划出院前 24 小时内测量一次

测量方法：

采用中文版《一般自我效能感量表》（Chinese General Self?Efficacy Scale, C?GSES），共 10 个条目，每题 1～4 分，总分 10～40 分。 10–19 分为低自我效能，20–29 分为中等，30–40 分为高自我效能，得分越高表示父母在面对困难和照护挑战时越有信心。

Measure time point of outcome：

Measure once within 24 hours before the planned discharge.

Measure method：

The Chinese version of the General Self-Efficacy Scale (C-GSES) was employed, consisting of 10 items scored from 1 to 4 points each, yielding a total score ranging from 10 to 40. A score of 10–19 indicates low self-efficacy, 20–29 denotes moderate self-efficacy, and 30–40 reflects high self-efficacy. Higher scores signify greater confidence among parents in coping with difficulties and caregiving challenges.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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）：

无

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

None

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：

开放标签

Blinding：

Open-label study

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）：

2028年1月共享，通过邮箱申请

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

Shared in January 2028, apply via email.

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：

病理记录表

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-24 16:02:43
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