Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
NCT Number: NCT02337621
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.
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Notify Me12 year–17 year
All sexes
Observational
Phoenix, Arizona, 85016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
child self report and parental report via PedsQL; increased scores mean better outcomes
Phoenix Children's Hospital
Other
Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being
Acronym: PEP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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