Pain, Exercise and Psychological Well-being in Pectus Excavatum

Pectus Excavatum Clinical Trial

— PEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337621
• Other study ID #: #14-124
• Status: Completed
• Start date: May 2015
• Est. completion date: September 2021

Study information

• Verified date: April 2022
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Fonkalsrud EW. Current management of pectus excavatum. World J Surg. 2003 May;27(5):502-8. Epub 2003 Apr 28. Review. — View Citation

Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234. Review. — View Citation

Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723. — View Citation

Kelly RE Jr, Mellins RB, Shamberger RC, Mitchell KK, Lawson ML, Oldham KT, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Cooper D, Bagley T, Quinn A, Moskowitz AB, Paulson JF. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes. J Am Coll Surg. 2013 Dec;217(6):1080-9. doi: 10.1016/j.jamcollsurg.2013.06.019. — View Citation

Khan RS, Skapinakis P, Ahmed K, Stefanou DC, Ashrafian H, Darzi A, Athanasiou T. The association between preoperative pain catastrophizing and postoperative pain intensity in cardiac surgery patients. Pain Med. 2012 Jun;13(6):820-7. doi: 10.1111/j.1526-4637.2012.01386.x. Epub 2012 May 8. — View Citation

Maagaard M, Tang M, Ringgaard S, Nielsen HH, Frøkiær J, Haubuf M, Pilegaard HK, Hjortdal VE. Normalized cardiopulmonary exercise function in patients with pectus excavatum three years after operation. Ann Thorac Surg. 2013 Jul;96(1):272-8. doi: 10.1016/j.athoracsur.2013.03.034. Epub 2013 May 14. — View Citation

Nuss D, Kelly RE Jr, Croitoru DP, Katz ME. A 10-year review of a minimally invasive technique for the correction of pectus excavatum. J Pediatr Surg. 1998 Apr;33(4):545-52. — View Citation

Tang M, Nielsen HH, Lesbo M, Frøkiær J, Maagaard M, Pilegaard HK, Hjortdal VE. Improved cardiopulmonary exercise function after modified Nuss operation for pectus excavatum. Eur J Cardiothorac Surg. 2012 May;41(5):1063-7. doi: 10.1093/ejcts/ezr170. Epub 2011 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health related quality of life	child self report and parental report via PedsQL; increased scores mean better outcomes	change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Primary	Improvement in pain scores	pain diary and self report via questionnaires	change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Primary	Increase in activity level/exercise	wireless activity monitor and physical therapy notes	change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Secondary	mood	child self report and parental report via questionnaires	change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Secondary	body image	child self report and parental report via modified Y-BOCS ; increased scores mean worse body image	change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)

External Links

•   Pectus Excavatum Mobility and Stretching Exercises