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

June 25, 2013 updated by: Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Pediatric Chronic Pain

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - The Pediatric Chronic Pain Medicine Program at Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline at time of initial outpatient clinic visit
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)	Baseline at the time of initial outpatient clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

F081114005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.