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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postoperative Pain Assessment in Children with Congenital Heart Disease
研究概览
简要总结
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
- 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.
详细描述
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.
2. To explore the impact of this model on anxiety levels and nursing satisfaction among family members of pediatric patients.
3. Develop a standardized and scalable animated nursing process for postoperative patient-nurse interaction in children with congenital heart disease.
2. Study Subjects and Methods (1) Study Subjects The study subjects were children undergoing radical surgery for congenital heart disease in the Department of Cardiac Surgery of a tertiary Grade A children's hospital. The inclusion and exclusion criteria were as follows: 1. Inclusion Criteria-Age 3-7 years, with normal cognitive function and the ability to normally watch animations; -Scheduled for elective radical surgery for congenital heart disease, requiring postoperative admission to the intensive care unit (ICU) for observation; -Informed consent from the child's family members, with voluntary participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Weeks 至 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •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;
排除标准
- •Inclusion criteria:
- •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;
研究组 & 干预措施
Based on the nurse-patient interaction model in animated cartoons
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.
干预措施: Routine care (Other)
结局指标
主要结局
Postoperative Pain Assessment in Children with Congenital Heart Disease
时间窗: 1 hours after tube removal to 48 hours after surgery
Pain scores at 1 hour, 6 hours, 24 hours, and 48 hours after extubation
Pain Assessment
时间窗: 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.
次要结局
未报告次要终点