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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
204
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.
Anxiety levels of children
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.
Time frame: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
Anxiety levels of primary caregivers
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.
Time frame: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
Preoperative hospital satisfaction
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.
Time frame: At discharge from the preoperative ward (assessed up to 5 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.