Pain, Exercise and Psychological Well-being in Pectus Excavatum (PEP)
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|ClinicalTrials.gov Identifier: NCT02337621|
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment|
|Pectus Excavatum||Other: No intervention|
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|
|Estimated Enrollment :||10 participants|
|Official Title:||Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
pectus excavatum surgical candidates
Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum
Other: No intervention
- 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
- 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
- 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 questionnaires
- 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
- 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 questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337621
|Contact: Erica Baimbridge, M.Edemail@example.com|
|United States, Arizona|
|Phoenix Children's Hospital||Recruiting|
|Phoenix, Arizona, United States, 85016|
|Contact: Erica Baimbridge, M.Ed 602-933-1000 firstname.lastname@example.org|
|Principal Investigator:||Lisa McMahon, MD||Phoenix Children's Hospital|