NCT07319260

Brief Summary

I. Research Objective To verify the efficacy of an animated nurse-patient interaction model in alleviating postoperative pain in children with congenital heart disease, optimize non-pharmacological analgesic nursing processes for children post-surgery, and improve family nursing satisfaction. II. Research Subjects Thirty-five children aged 3-7 years who underwent curative surgery for congenital heart disease were selected and randomly divided into an observation group and a control group, each consisting of 35 cases.

  • Inclusion criteria: Normal cognitive function, admitted to the intensive care unit post-surgery, and family informed consent obtained.
  • Exclusion criteria: Concurrent severe organ or neurological diseases, occurrence of severe postoperative complications, or resistance to animated intervention. III. Research Methods
  • Intervention Measures
  • Control group: Implemented routine postoperative pain management for congenital heart disease (pharmacological analgesia + basic nursing).
  • Observation group: On the basis of routine nursing, preoperative assessment of children's animated preferences was conducted. Appropriate-age animations were played 15-30 minutes per session, 3-4 times per day when the child's vital signs were stable post-surgery. Nurses synchronized interactive activities, and pain was assessed every 2 hours, with intervention strategies adjusted based on scoring.
  • Observation Index
  • Statistical Analysis: SPSS 26.0 software was used. t-test was performed for measurement data, and χ² test was performed for counting data. P \< 0.05 was considered as statistically significant difference.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 9, 2025

Last Update Submit

December 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Assessment in Children with Congenital Heart Disease

    Pain scores at 1 hour, 6 hours, 24 hours, and 48 hours after extubation

    1 hours after tube removal to 48 hours after surgery

  • Pain Assessment

    This study used the Wong-Baker FACES Pain Rating Scale for pain assessment in children. The Wong-Baker FACES Pain Rating Scale was originally developed by Donna Wong and Dr. Connie Baker for measuring children's pain. It was later revised to form the FPS-R scale. This method began to be used in clinical assessment in 1990. It uses six facial expressions ranging from smiling to crying to represent different degrees of pain. During assessment, the child only needs to select one expression that represents their pain level (see Figure 1 for details). The total score is 10 points, where 0-3 indicates no pain or mild pain; 4-7 indicates moderate pain; and 8-10 indicates severe pain. This scale has a wide range of applications, suitable for children of all ages, does not require the child to have a specific cultural background, and is easy to master. Studies by Garra et al.have validated the effectiveness of the Wong-Baker FACES Pain Rating Scale. Studies by Newman et al.

    The responsible nurse used the Wong-Baker Facial Expression Scale to assess pain at 1 hour, 6 hours after tube removal, 24 hours, and 48 hours post-operation, and recorded the scores on the corresponding assessment forms. The researchers reviewed these a

Study Arms (1)

Based on the nurse-patient interaction model in animated cartoons

EXPERIMENTAL

Establish an animation database: Since children of different ages prefer different cartoons, and considering that each child has different individual psychological characteristics, each child likes different cartoons. When using cartoons, to ensure that the cartoons have a certain level of appeal to the children and capture each child's attention, the research team established an animation database before the intervention group was implemented. This allows nursing staff to watch and select the 3 favorite cartoons with the child before the procedure.They were cared for by the same group of nursing staff as the control group, but before the intervention, during the interval period, the researchers completed training on the implementation plan of the patient-nurse interaction model based on animated films and the data collection methods for the intervention group.

Other: Routine care

Interventions

Routine care

Also known as: Control group Routine postoperative care
Based on the nurse-patient interaction model in animated cartoons

Eligibility Criteria

Age3 Weeks - 7 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with CHD and treated with surgical intervention according to the 'Pediatric Congenital Heart Disease Diagnosis and Treatment Guidelines' and echocardiographic images \[100\];
  • Age between 3 to 7 years, including 3 years and 7 years;
  • Surgical procedure is thoracotomy;
  • Diagnosed with ventricular septal defect, atrial septal defect, or atrial septal defect combined with ventricular septal defect, patent ductus arteriosus, or tetralogy of Fallot;

You may not qualify if:

  • Children diagnosed with CHD and treated with surgical intervention according to the 'Pediatric Congenital Heart Disease Diagnosis and Treatment Guidelines' and echocardiographic images \[100\];
  • Age between 3 to 7 years, including 3 years and 7 years;
  • Surgical procedure is thoracotomy;
  • ④ Diagnosed with ventricular septal defect, atrial septal defect, or atrial septal defect combined with ventricular septal defect, patent ductus arteriosus, or tetralogy of Fallot;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study on the effect of cartoon nurse-patient interaction mode on postoperative pain in children with congenital heart disease

Beijing, China

Location

Related Publications (1)

  • Chen Y, Guo Y, Zhu YB, Kang X, Liu JH. Animation-Based Caregiver-Patient Interaction Model for Postoperative Pain Management in Preschool Children with Congenital Heart Disease. J Vis Exp. 2026 Mar 13;(229). doi: 10.3791/69592.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 6, 2026

Study Start

August 22, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations