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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease (CHD)
• Intervention / Treatment: Behavioral: Therapeutic Play Intervention; Behavioral: Routine Preoperative Nursing

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinglan Li; Phone Number: +86 15912992590; Email: 1057385776@qq.com
• Study Contact Backup: Name: Ruijie Yanglan; Phone Number: +89 18887278258; Email: 1052076436@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Routine Preoperative Care Group; Children in this group receive routine preoperative care, including fasting guidance, medication preparation, and standard health education.	Behavioral: Routine Preoperative Nursing; Standard preoperative care including fasting guidance, medication preparation, and health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At discharge from the preoperative ward (assessed up to 5 days)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Kunming Medical University
• Investigators: Principal Investigator: Fang Ma, PhD, First Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; anxiety; pediatric patient; therapeutic play
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anxiety Disorders; Heart Defects, Congenital
• Other Study ID Numbers: KMMU-2026-001; 72364022 (Other Grant/Funding Number: National Natural Science Foundation of China (NSFC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly due to patient privacy and confidentiality requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No