Clinical trial NCT00885976: The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain
Official title: The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Chronic Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 99
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: Heath-related quality of life
timeFrame: Baseline at time of initial outpatient clinic visit
measure: Pain intensity and functional disability
timeFrame: Baseline at the time of initial outpatient clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Pediatric Chronic Pain Medicine Program at Children's Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Thomas R. Vetter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vetter TR, Bridgewater CL, McGwin G Jr. An observational study of patient versus parental perceptions of health-related quality of life in children and adolescents with a chronic pain condition: who should the clinician believe? Health Qual Life Outcomes. 2012 Jul 23;10:85. doi: 10.1186/1477-7525-10-85.