Congenital Heart Disease (CHD)TP-CHDNCT07643168
The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease
A study testing Therapeutic Play Intervention and Routine Preoperative Nursing in people with Congenital Heart Disease (CHD), run by First Affiliated Hospital of Kunming Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Therapeutic Play Intervention and Routine Preoperative Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Therapeutic Play Intervention, Routine Preoperative Nursing
- Keywords
- therapeutic play, anxiety, Congenital Heart Disease, pediatric patient
- Medical subject headings
- Heart Defects, Congenital, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Play InterventionBehavioural
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 NursingBehavioural
Standard preoperative care including fasting guidance, medication preparation, and health education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Preoperative Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)
Secondary outcomes (1)
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.
Measured: At discharge from the preoperative ward (assessed up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li QingLan, First Affiliated Hospital of Kunming Medical University
- Investigators
- Fang Ma, PhD, Principal investigator, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643168
- Sponsor's protocol ID
- KMMU-2026-001
- Other IDs
- 72364022
- Acronym
- TP-CHD
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to patient privacy and confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07643168
- Acronym / sponsor ID
- TP-CHD / KMMU-2026-001
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- therapeutic play, anxiety, Congenital Heart Disease, pediatric patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Play Group | Experimental | Behavioral: Therapeutic Play Intervention, Behavioral: Routine Preoperative NursingChildren 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. |
| Routine Preoperative Care Group | Active comparator | Behavioral: Routine Preoperative NursingChildren in this group receive routine preoperative care, including fasting guidance, medication preparation, and standard health education. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Play InterventionIntervention 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. | Behavioural | Therapeutic Play Group |
| Routine Preoperative NursingStandard preoperative care including fasting guidance, medication preparation, and health education. | Behavioural | Routine Preoperative Care Group, Therapeutic Play Group |
Primary outcome
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.
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.
1 secondary outcome
Preoperative hospital satisfaction
Time frame: At discharge from the preoperative ward (assessed up to 5 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to patient privacy and confidentiality requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Ma, PhD principal investigator
First Affiliated Hospital of Kunming Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Play Intervention and Routine Preoperative Nursing in people with Congenital Heart Disease (CHD), run by First Affiliated Hospital of Kunming Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinglan Li (+86 15912992590, 1057385776@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels of children (time frame: Baseline (T0, pre-intervention), immediately post-intervention (T1), and during anesthesia induction (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.