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Pain, Exercise and Psychological Well-being in Pectus Excavatum

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02337621
Acronym
PEP
Enrollment
6
Registered
2015-01-13
Start date
2015-05-31
Completion date
2021-09-30
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus Excavatum

Keywords

sunken chest, caved-in chest, chest deformity, sunken sternum

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.

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.

Interventions

OTHERNo intervention

Sponsors

Phoenix Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in pain scoreschange 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/exercisechange 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

MeasureTime frameDescription
moodchange 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 imagechange 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

MeasureTime frameDescription
health related quality of lifechange 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026