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Completed

NCT Number: NCT02337621

Pain, Exercise and Psychological Well-being in Pectus Excavatum

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Improvement in pain scores

    Time frame: 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

  2. 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)

    wireless activity monitor and physical therapy notes

Secondary outcomes

  1. mood

    Time frame: 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

  2. body image

    Time frame: 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 outcomes

  1. 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)

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

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Acronym: PEP

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jan 13, 2015
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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