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

NCT07643168 | Not Yet Recruiting

• 2 other identifiers: KMMU-2026-00172364022
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Keywords

therapeutic play; anxiety; Congenital Heart Disease; pediatric patient

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Preoperative hospital satisfaction

  At discharge from the preoperative ward (assessed up to 5 days)

Study Arms (2)

Therapeutic Play Group

EXPERIMENTAL

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; Behavioral: Routine Preoperative Nursing

Routine Preoperative Care Group

ACTIVE COMPARATOR

Children in this group receive routine preoperative care, including fasting guidance, medication preparation, and standard health education.

Behavioral: Routine Preoperative Nursing

Interventions

Therapeutic Play Intervention BEHAVIORAL

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.

Therapeutic Play Group

Routine Preoperative Nursing BEHAVIORAL

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

Routine Preoperative Care Group; Therapeutic Play Group

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

MeSH Terms

Conditions

Heart Defects, Congenital; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Officials

• Fang Ma, PhD

  First Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglan Li

CONTACT

+86 15912992590; 1057385776@qq.com

Ruijie Yanglan

CONTACT

+89 18887278258; 1052076436@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share