The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Post-operative pain score
研究概览
简要总结
The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain.
Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively.
Specific Aim 2: To compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving.
Specific Aim 3: To examine potential moderators of pain response in the massage intervention group before and after receiving massage.
详细描述
We used a two-group randomized clinical trial design with a sample of 60 infants with complex congenital heart disease (CCHD) between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group 1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Research assistants scoring participant pain were blinded to group.
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born with complex congenital heart disease requiring surgical intervention
- •less than 12 months old
- •undergoing first surgical procedure
排除标准
- •on paralytics post-operatively
- •cardiorespiratory instability
- •on-going cardiac pacing
结局指标
主要结局
Post-operative pain score
时间窗: Daily average for 7 days
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Heart rate
时间窗: Daily average for 7 days
heart rate in beats per minute
Respiratory rate
时间窗: Daily average for 7 days
respiratory rate in breaths per minute
Change in respiratory rate with intervention
时间窗: Daily for 7 days
respiratory rate in beats per minute
Change in oxygen saturation with intervention
时间窗: Daily for 7 days
oxygen saturation percentage
Change in post-operative pain score with intervention
时间窗: Daily for 7 days
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Oxygen saturation
时间窗: Daily average for 7 days
oxygen saturation percentage
Change in heart rate with intervention
时间窗: Daily for 7 days
heart rate in beats per minute
次要结局
未报告次要终点
研究者
Tondi Harrison
Principal Investigator
Ohio State University