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

Sponsor

Phoenix Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02337621

Collaborator

(none)

Enrollment

Location

76.1

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Other: No intervention

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 Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
pectus excavatum surgical candidates Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum	Other: No intervention

Arm

Intervention/Treatment

pectus excavatum surgical candidates

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

Other: No intervention

Outcome Measures

Primary Outcome Measures

Improvement in pain scores [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 [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

Secondary Outcome Measures

mood [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 [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 modified Y-BOCS ; increased scores mean worse body image

Other Outcome Measures

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)]
child self report and parental report via PedsQL; increased scores mean better outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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