Pain, Exercise and Psychological Well-being in Pectus Excavatum
- Conditions
- Pectus Excavatum
- Interventions
- Other: No intervention
- Registration Number
- NCT02337621
- Lead Sponsor
- Phoenix Children's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pectus excavatum surgical candidates No intervention Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum
- Primary Outcome Measures
Name Time Method Improvement in pain scores 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 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
- Secondary Outcome Measures
Name Time Method mood change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months) child self report and parental report via questionnaires
body image change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months) child self report and parental report via modified Y-BOCS ; increased scores mean worse body image
Trial Locations
- Locations (1)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States