Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Improvement in pain scores
研究概览
简要总结
Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.
详细描述
Major surgery has a drastic impact on the lives of patients and their families. Often, patients undergoing the Nuss procedure have lingering pain which can complicate recovery. Depending on the nature of the surgery and the severity of disease, this recovery period can be as short as a few days, or it can take several weeks and even months. Few studies have demonstrated the benefit of physical activity and exercise postoperatively on returning to normal function. Additionally, research has suggested that pain and recovery can be influenced by psychological factors.
The investigators will use wireless activity monitors to assess the activity levels of children who undergo major musculoskeletal surgery, specifically the Nuss procedure. The investigators will also evaluate this population for psychological well-being. In this pilot study, the investigators identify goals and objectives which will provide preliminary evidence for physical and psychological recommendations to reduce post-operative pain and improve recovery.
Families will be asked to complete questionnaires at different phases in the surgery (pre-surgery, post bar insertion, post bar removal). Children will be instructed to record any pain they are experiencing as a result of their condition or the surgery at various time points. The activity levels will also be followed over the course of the recovery period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum
排除标准
- •History of chronic pain disorders
- •History of major mental illness such as psychosis or bipolar disorder
- •Cognitive impairment significantly below average age and/or grade level
- •Non-English speaking parent or child
- •Unable to obtain and keep access to a cellular phone
- •Loss of wireless electronic activity monitor and refusal to replace to remain in the study
结局指标
主要结局
Improvement in pain scores
时间窗: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
pain diary and self report via questionnaires
Increase in activity level/exercise
时间窗: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
wireless activity monitor and physical therapy notes
次要结局
- mood(change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months))
- body image(change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months))
研究者
Lisa McMahon, MD
Attending
Phoenix Children's Hospital