Pain, Exercise and Psychological Well-being in Pectus Excavatum (PEP)
April 18, 2022 updated by: Lisa McMahon, MD, Phoenix Children's Hospital
Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pectus excavatum surgical candidates
Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Improvement in pain scores
Time Frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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pain diary and self report via questionnaires
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change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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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)
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wireless activity monitor and physical therapy notes
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change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mood
Time Frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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child self report and parental report via questionnaires
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change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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body image
Time Frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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child self report and parental report via modified Y-BOCS ; increased scores mean worse body image
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change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
health related quality of life
Time Frame: change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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child self report and parental report via PedsQL; increased scores mean better outcomes
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change of quality of life from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa McMahon, MD, Phoenix Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
January 12, 2015
First Posted (Estimate)
January 13, 2015
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #14-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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