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NOT YET RECRUITING
NCT07643168
NA

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

Sponsor: First Affiliated Hospital of Kunming Medical University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

0 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2026-06

Completion Date

2026-12

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Routine Preoperative Nursing

Standard preoperative care including fasting guidance, medication preparation, and health education.