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

NCT00885976 | Completed

• 1 other identifier: F081114005
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Heath-related quality of life

  PedsQLTM 4.0 and 36-Item Short-Form Health Survey Version 2 (SF-36v2)

  Baseline at time of initial outpatient clinic visit

• Pain intensity and functional disability

  Pediatric Pain Questionnaire (PPQ) and Functional Disability Inventory (FDI)

  Baseline at the time of initial outpatient clinic visit

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The Pediatric Chronic Pain Medicine Program at Children's Hospital

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 22824550 RESULT

Study Officials

• Thomas R. Vetter, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

US (1)