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The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease (TP-CHD)

2026年6月9日 更新者:Li QingLan、First Affiliated Hospital of Kunming Medical University

The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease: A Randomized Controlled Trial

Congenital Heart Disease (CHD) is the most common congenital malformation in children and the leading cause of death from birth defects in infancy. Preoperative anxiety is prevalent in children with CHD, but current preoperative care mainly focuses on physical preparation, with insufficient attention to psychological stress, and conventional intervention measures have limitations. As a non-pharmacological method, therapeutic play has been proven effective in relieving children's anxiety, but randomized controlled trials (RCTs) of therapeutic play for preoperative anxiety in children with CHD are still lacking in China. This study adopts a randomized controlled design, in which children with CHD before surgery are randomly divided into the experimental group and the control group. The experimental group receives therapeutic play (including parents' participation, with intervention content designed according to children's cognitive characteristics), while the control group receives routine preoperative nursing. The effect of therapeutic play on relieving preoperative anxiety in children with CHD will be evaluated multi-dimensionally through anxiety scale scores, vital signs, and salivary cortisol levels, providing scientific evidence for clinical intervention of preoperative anxiety in children with CHD.

研究概览

研究类型

介入性

注册 (估计的)

204

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

Children diagnosed with congenital heart disease via clinical and imaging examinations, scheduled for elective cardiac surgery (e.g., open-heart surgery under cardiopulmonary bypass, open chest device closure, or percutaneous interventional treatment).

  • Aged 0 to 12 years old, with basic communication and comprehension abilities to respond to play interventions and complete anxiety scale assessments.
  • Clear consciousness, no severe intellectual, hearing, or speech communication disorders, or pervasive developmental disorders (e.g., autism), and being able to interact with researchers.
  • Primary caregivers (father or mother) provide written informed consent and have the ability to understand the study and assist the child with the intervention.

Exclusion Criteria:

  • Children with complex critical CHD requiring emergency surgery or admission to the intensive care unit (ICU) upon hospitalization.
  • Children with severe neurological disorders (e.g., cerebral palsy, epilepsy), severe hepatic/renal insufficiency, or other major congenital diseases that may affect psychological status or perioperative progress.
  • Children who have taken sedatives, anxiolytics, or antidepressants long-term preoperatively, whose anxiety levels have been altered by medication.
  • Participants who cannot complete the intervention or outcome assessments for any reason (e.g., surgery cancellation, withdrawal of consent).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Therapeutic Play Group
Children in this group receive routine preoperative preparation plus a structured therapeutic play intervention. The play intervention is tailored to the child's cognitive level, with parental involvement, to reduce preoperative anxiety.
Intervention Description :children receive routine preoperative preparation plus a structured, age-appropriate therapeutic play intervention. The play activities, involving parent-child interaction, are tailored to the child's cognitive level to distract attention, reduce fear, and relieve preoperative anxiety before congenital heart disease surgery.
Standard preoperative care including fasting guidance, medication preparation, and health education.
有源比较器:Routine Preoperative Care Group
Children in this group receive routine preoperative care, including fasting guidance, medication preparation, and standard health education.
Standard preoperative care including fasting guidance, medication preparation, and health education.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Anxiety levels of children
大体时间:Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
For children: Chinese Version of the Modified Yale Preoperative Anxiety Scale (m-YPAS), full scale range 23 ~ 100 points. Higher scores indicate greater preoperative anxiety (worse outcome); lower scores represent milder anxiety.
Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
Anxiety levels of primary caregivers
大体时间:Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
For primary caregivers: State-Trait Anxiety Inventory (STAI, State Anxiety Subscale), full scale range 20 ~ 80 points. Higher scores indicate higher caregiver anxiety (worse outcome); lower scores mean less anxiety.
Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)

次要结果测量

结果测量
措施说明
大体时间
Preoperative hospital satisfaction
大体时间:At discharge from the preoperative ward (assessed up to 5 days)
Satisfaction with preoperative care will be assessed via self-developed satisfaction questionnaire completed by primary caregivers, with scores ranging from 0 to 100; higher scores correspond to better preoperative care satisfaction.
At discharge from the preoperative ward (assessed up to 5 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Fang Ma, PhD、First Affiliated Hospital of Kunming Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • KMMU-2026-001
  • 72364022 (其他赠款/资助编号:National Natural Science Foundation of China (NSFC))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared publicly due to patient privacy and confidentiality requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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