Study on the effect of cartoon nurse-patient interaction mode on postoperative pain in children with congenital heart disease
Beijing, China
NCT Number: NCT07319260
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
1. 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. 2. Observation Index
- Secondary indicators: Child anxiety score, family anxiety score (SAS), nursing satisfaction. 3. 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.
IV. Implementation Steps 1. Preparation Phase: Form a team, develop the protocol and informed consent form, and train the researchers. 2. Intervention phase: Recruitment and grouping of subjects, implementation of interventions, and data collection. 3. Analysis and Summary Phase: Conduct statistical analysis of data, prepare reports, and establish standardized nursing procedures.
V. Ethics and Expected Outcomes Ethics: With approval from the hospital's ethics committee and after obtaining informed consent from the family, the child may voluntarily withdraw from the study. The control group will receive equivalent intervention opportunities after completing the study.
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All sexes
Interventional
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Beijing, China
Research Protocol for Postoperative Pain Management in Children with Congenital Heart Disease Based on the Animation-Patient Interaction Model Background and Objectives (1) Research Background Congenital heart disease is one of the common congenital malformations in children, with surgical intervention being the primary treatment modality. Postoperative wound pain and catheter irritation can easily trigger crying and agitation in pediatric patients, not only impairing wound healing and postoperative recovery but also increasing psychological burden on parents. Traditional pain management primarily relies on pharmacological analgesia, which carries certain side effects. Moreover, young patients exhibit limited capacity for pain expression, making precise assessment and intervention challenging. The animation-patient interaction model represents an innovative approach that integrates age-appropriate animated content into perioperative care. By diverting children's attention and alleviating negative emotions, this method reduces pain perception, providing a novel non-pharmacological intervention direction for postoperative pain management in pediatric patients.
(2) Research Objectives 1. To evaluate the efficacy of the animated nurse-patient interaction model in improving postoperative pain scores, crying duration, and sleep quality in children with congenital heart disease.
A controlled trial was conducted, with eligible pediatric patients divided into an observation group and a control group at a 1:1 ratio, each comprising 35 cases. (II) Research Methods 1. Intervention Method-Control Group: The conventional postoperative pain management protocol for congenital heart disease was implemented, including prescribed analgesics, positional care, wound care, and basic psychological reassurance.
Secondary indicators: anxiety scores of pediatric patients, anxiety scores of family members (using the Self-Rating Anxiety Scale, SAS); nursing satisfaction scores (using a hospital-developed nursing satisfaction questionnaire).
-Data analysis was performed using SPSS 26.0 statistical software. Measurement data were expressed as mean ± standard deviation, and intergroup comparisons were conducted using t-test. Categorical data were expressed as rates, and intergroup comparisons were performed using χ² test. A P-value <0.05 was considered statistically significant.
III. Research Content and Implementation Steps (1) Research Content 1. Standardization process construction of the animated patient-nurse interaction model, including animation screening criteria, playback timing, interaction methods, and effect evaluation dimensions.
(2) Implementation Steps 1. Preparation Phase: Establish a research team comprising cardiac surgery nurses, pediatric nursing researchers, and statistical analysts; develop the research protocol and informed consent form; train researchers to standardize intervention methods and data collection criteria.
IV. Ethical Considerations 1. This research protocol was implemented after approval by the hospital ethics committee.
V. Promotional Value This model is characterized by its simplicity, low cost, and high safety, making it suitable for widespread application in pediatric and cardiac surgery departments across all levels of hospitals. It not only enhances the quality of postoperative pain management in children but also optimizes the nurse-patient relationship and improves family satisfaction.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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;
Routine care
Other names: Control group Routine postoperative care
Time frame: 1 hours after tube removal to 48 hours after surgery
Pain scores at 1 hour, 6 hours, 24 hours, and 48 hours after extubation
Time frame: 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
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.
Beijing Children's Hospital
Other
All Children Underwent Congenital Heart Disease (CHD) Surgery Under General Anesthesia. The Intervention Group and Control Group Each Had 35 Children. The Control Group Received Routine Pain Care, While the Intervention Group Received Nursing Based on Animated Film-based Nurse-patient Interactive Mode in Addition to Routine Pain Care.
Acronym: CCU
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