Not Yet RecruitingNot Applicable

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

204 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

0 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety levels of children

Timeframe: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)

Anxiety levels of primary caregivers

Timeframe: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)

Trial details

NCT IDNCT07643168

SponsorFirst Affiliated Hospital of Kunming Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Qinglan Li

+86 15912992590 1057385776@qq.com

View on ClinicalTrials.gov More Congenital Heart Disease (CHD) trials