Coping After Pediatric Scoliosis Surgery: How Does it Affect Pain and Function?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Post-Operative Pain
研究概览
简要总结
This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.
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
- Single (Care Provider)
盲法说明
All clinicians and care providers are blinded to participants randomized group
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Non-English speaking
- •Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.
- •Other comorbidity, including developmental delay.
- •Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.
- •Unplanned admission within 6 weeks of index operation.
- •Active treatment psychotherapy and/or cognitive behavioral therapy for any reason
结局指标
主要结局
Post-Operative Pain
时间窗: Up to 6-weeks post-operatively
Outcome #1 will evaluate the intervention's impact on post-operative pain via completion of the computer-adaptive NIH PROMIS measures on pain intensity and pain behavior. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
次要结局
- Patient Reported Outcomes - Physical Activity(Up to 6-weeks post-operatively)
- Patient Reported Outcomes - Global Health(Up to 6-weeks post-operatively)
- Patient Reported Outcomes - Mobility(Up to 6-weeks post-operatively)
- Patient Reported Outcomes - Positive Affect(Up to 6-weeks post-operatively)
- Patient Reported Outcomes - Strength Impact(Up to 6-weeks post-operatively)