An observational study in Pectus Excavatum, sponsored by Phoenix Children's Hospital. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Phoenix Children's Hospital · Observational
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.
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 6 is below the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum
Other: No intervention
Improvement in pain scores
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)
Increase in activity level/exercise
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)
mood
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)
body image
child self report and parental report via modified Y-BOCS ; increased scores mean worse body image
Time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
health related quality of life
child self report and parental report via PedsQL; increased scores mean better outcomes
Time frame: change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Plan to share: Undecided
Ran from May 2015 to primary completion in Dec 2020, 67 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Phoenix Children's Hospital