Pain, Exercise and Psychological Well-being in Pectus Excavatum

NCT02337621 | Completed

• 1 other identifier: #14-124
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

sunken chest; caved-in chest; chest deformity; sunken sternum

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• mood

  change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)

• body image

  change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)

Other Outcomes (1)

• health related quality of life

  change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)

Study Arms (1)

pectus excavatum surgical candidates

Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum

Other: No intervention

Interventions

No intervention OTHER

pectus excavatum surgical candidates

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (8)

• Fonkalsrud EW. Current management of pectus excavatum. World J Surg. 2003 May;27(5):502-8. doi: 10.1007/s00268-003-7025-5. Epub 2003 Apr 28.

  PMID: 12715210 BACKGROUND

• 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.

  PMID: 20207934 BACKGROUND

• Maagaard M, Tang M, Ringgaard S, Nielsen HH, Frokiaer 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.

  PMID: 23684487 BACKGROUND

• Tang M, Nielsen HH, Lesbo M, Frokiaer 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.

  PMID: 22219453 BACKGROUND

• 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.

  PMID: 24246622 BACKGROUND

• 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. doi: 10.1016/s0022-3468(98)90314-1.

  PMID: 9574749 BACKGROUND

• 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.

  PMID: 22568812 BACKGROUND

• 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.

  PMID: 19047237 BACKGROUND

Related Links

• Pectus Excavatum Mobility and Stretching Exercises

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lisa McMahon, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: January 13, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)