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

This study is currently recruiting participants.
Verified April 2017 by Lisa McMahon, MD, Phoenix Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02337621
First Posted: January 13, 2015
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa McMahon, MD, Phoenix Children's Hospital
  Purpose
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 Intervention
Pectus Excavatum Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being

Resource links provided by NLM:


Further study details as provided by Lisa McMahon, MD, Phoenix Children's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • quality of life [ 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

  • 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


Estimated Enrollment: 10
Study Start Date: May 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pectus excavatum surgical candidates
Any person who is eligible to undergo the Nuss procedure for surgical correction of 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.

  Eligibility

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Erica Baimbridge, M.Ed 602-933-3524 ebaimbridge@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Erica Baimbridge, M.Ed    602-933-1000    ebaimbridge@phoenixchildrens.com   
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Lisa McMahon, MD Phoenix Children's Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Lisa McMahon, MD, Attending, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT02337621     History of Changes
Other Study ID Numbers: #14-124
First Submitted: December 10, 2014
First Posted: January 13, 2015
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lisa McMahon, MD, Phoenix Children's Hospital:
sunken chest
caved-in chest
chest deformity
sunken sternum

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities