The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Therapeutic Play Intervention
  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.
• Поведенческое Routine Preoperative Nursing
  Standard preoperative care including fasting guidance, medication preparation, and health education.

Первичные конечные точки

• Anxiety levels of children [Срок оценки: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)]
• Anxiety levels of primary caregivers [Срок оценки: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)]

Вторичные конечные точки (1)

• Preoperative hospital satisfaction [Срок оценки: At discharge from the preoperative ward (assessed up to 5 days)]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07643168 · KMMU-2026-001 · 72364022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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