Pain, Exercise and Psychological Well-being in Pectus Excavatum

NCT ID: NCT02337621

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-09-30

Brief Summary

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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 Description

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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.

Conditions

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Pectus Excavatum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pectus excavatum surgical candidates

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

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lisa McMahon, MD

Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa McMahon, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12715210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20207934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23684487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22219453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24246622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9574749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22568812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19047237 (View on PubMed)

Related Links

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https://www.youtube.com/watch?v=hy8C__bCJXM

Pectus Excavatum Mobility and Stretching Exercises

Other Identifiers

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#14-124

Identifier Type: -

Identifier Source: org_study_id

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