Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07643168

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Routine Preoperative Nursing

Behavioral

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

Primary outcomes

  1. Anxiety levels of children

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

    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.

  2. Anxiety levels of primary caregivers

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

    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.

Secondary outcomes

  1. Preoperative hospital satisfaction

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qinglan Li

CONTACT

[email protected]

+86 15912992590

Ruijie Yanglan

CONTACT

[email protected]

+89 18887278258

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

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

Acronym: TP-CHD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.