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

Pediatric Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885976
• Other study ID #: F081114005
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: June 25, 2013
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Pediatric Chronic Pain

Locations

Country	Name	City	State
United States	The Pediatric Chronic Pain Medicine Program at Children's Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Pain intensity and functional disability	Pediatric Pain Questionnaire (PPQ) and Functional Disability Inventory (FDI)	Baseline at the time of initial outpatient clinic visit	No