Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00884780|
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : July 31, 2013
|Condition or disease|
Approximately 1 in 4 children aged 5-18 report experiencing pain. As many as 2 in 3 of these children will develop a significant physical, emotional, social or academic impairment. Recent research has identified pediatric pain as an area where biological, psychological and social treatments can interact to provide substantial changes in pain symptoms. However, there is a lamentable dearth of empirical studies evaluating the efficacy of treatments for chronic pain in children. These findings necessitate more intensive efforts to improve methods on initial assessment and treatment, but an important first step is to improve the sensitivity of outcome evaluation.
Existing measures of pediatric pain have been concerned with symptom intensity and the general locus of pain. Children are traditionally asked to mark with a number or a color the region in which they experience pain. This is helpful for understanding generality that a large area such as the head, joints, or stomach hurts. However, it does not allow the child the option to specify a narrow area of discomfort within a broader region (e.g., upper right quadrant of the stomach). Consequently, current pain instruments may lead to an inaccurate or imprecise understanding of a child's pain, which can adversely impact clinical care of the quality of clinical trials.
The current study will compare a widely used paper-based "pain mapping" tool to a new electronic tool designed by study investigators to capture the same information as the paper measure, while adding more precision regarding pain regions and greater range in terms of pain intensity. We expect that children's responses on these two measures (pencil/paper and electronic) will be generally similar, but we expect that the electronic measure will map more closely onto the Attending Physician's notes regarding discrete pain location, intensity, and/or diagnosis.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Development of a New Electronic Measure of Pediatric Pain: A Pilot Study|
|Study Start Date :||April 2009|
|Primary Completion Date :||June 2009|
|Study Completion Date :||July 2009|
Children between the ages of 8 and 17 experiencing pain.
- To establish initial acceptability and feasibility of an electronic tool for pain assessment. [ Time Frame: One-time standard of care visit. ]
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): NCT00884780
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Study Chair:||Craig A Friesen, M.D.||Children's Mercy Hospital - Gastroenterology:Abdominal Pain Team|
|Study Chair:||Mark Connelly, PhD||The Children's Mercy Hospital: Integrative Pain Medicine Clinic|
|Study Chair:||Joy Weydert, M.D||The Children's Mercy Hospital: Integrative Pain Management Clinic|
|Principal Investigator:||Jennifer V Schurman, PhD||Children's Mercy Hospital|
|Study Chair:||Christopher C Cushing, PhD||Children's Mercy Hospital|