The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00885976
First received: April 20, 2009
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

This study is intended to provide additional insight into the factors affecting health-related quality of life with pediatric chronic pain as perceived by the patient versus his or her parents.In doing so, additional insight into the subjective interpretation the pediatric chronic pain experience will be gained. The four objectives of this study will be (a) to examine further the relationship between patient self-reported health-related quality of life and parent proxy-reported health-related quality; (b) to identify what biological, psychological, and/or social factors are the strongest predictors of a pediatric chronic pain patient's self-reported pain intensity and self-reported health-related quality of life, in a diverse cohort of patients referred to and subsequently treated by an anesthesiology-based yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and health-related quality of life; and (d) to determine the effect of patient/parental satisfaction with on-going health care on their compliance with and uptake of the pain treatment regimen.


Condition
Pediatric Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Heath-related quality of life [ Time Frame: Baseline at time of initial outpatient clinic visit ] [ Designated as safety issue: No ]
    PedsQLTM 4.0 and 36-Item Short-Form Health Survey Version 2 (SF-36v2)

  • Pain intensity and functional disability [ Time Frame: Baseline at the time of initial outpatient clinic visit ] [ Designated as safety issue: No ]
    Pediatric Pain Questionnaire (PPQ) and Functional Disability Inventory (FDI)


Enrollment: 99
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will come from those patients evaluated and treated in the Pediatric Chronic Pain Medicine Clinic at the Children's Hospital facilities. The likely study population includes essentially the pediatric population of the entire state of Alabama and immediately adjacent states (i.e., the geographic catchment area of the Children's Hospital of Alabama).

Criteria

Inclusion Criteria:

  • outpatients ranging between 8 years and 18 years of age directly referral from either their primary care physician or another specialist physician

Exclusion Criteria:

  • patients in whose biologic families English is not the primary, native language
  • patients suffering from severe cognitive dysfunction (i.e., mental retardation)
  • patients with a life-expectancy of less than three months at the time of initial clinical evaluation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885976

Locations
United States, Alabama
The Pediatric Chronic Pain Medicine Program at Children's Hospital
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Thomas R. Vetter, MD, MPH University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Thomas R. Vetter, MD, MPH, M.D., M.P.H., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00885976     History of Changes
Other Study ID Numbers: F081114005
Study First Received: April 20, 2009
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014