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

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ClinicalTrials.gov Identifier: NCT00885976
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Pediatric Chronic Pain

Study Design

Study Type : Observational
Actual Enrollment : 99 participants
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
Study Start Date : September 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Heath-related quality of life [ Time Frame: Baseline at time of initial outpatient clinic visit ]
    PedsQLTM 4.0 and 36-Item Short-Form Health Survey Version 2 (SF-36v2)

  2. Pain intensity and functional disability [ Time Frame: Baseline at the time of initial outpatient clinic visit ]
    Pediatric Pain Questionnaire (PPQ) and Functional Disability Inventory (FDI)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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).

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

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): NCT00885976

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
Principal Investigator: Thomas R. Vetter, MD, MPH University of Alabama at Birmingham
More Information

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
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms