Clinical Trial: Pain, Exercise and Psychological Well-being in Pectus Excavatum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being

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 Summary:

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.

Sponsor: Phoenix Children's Hospital

Current Primary Outcome:

• Improvement in pain scores [ 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
• Increase in activity level/exercise [ 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• quality of life [ 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
• mood [ 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
• body image [ 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

Original Secondary Outcome: Same as current

Information By: Phoenix Children's Hospital

Dates:
Date Received: December 10, 2014
Date Started: May 2015
Date Completion: December 2020
Last Updated: April 3, 2017
Last Verified: April 2017