Sickle Cell Disease Clinical Trial
Official title:
Home-based Pain Management Protocol for Children With Sickle Cell Disease
Verified date | April 2021 |
Source | University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sickle cell disease (SCD) is a devastating chronic health condition that primarily affects African-Americans. Painful episodes are the most frequent form of morbidity in SCD and the most frequent reason for hospitalization. Cognitive-behavioral interventions for pain management have shown efficacy for improving coping abilities, reducing the amount of medication needed to manage pain, and improving daily functioning during painful episodes. However, difficulties with disseminating and implementing cognitive-behavioral treatments have resulted in almost no use of these techniques in pediatric settings. In South Carolina these difficulties are compounded by social and geographical factors that pose particular challenges. A major issue with implementing quality pain management protocols is the difficulty with providing adequate practice and monitoring of the use of the techniques, particularly given the rural population in South Carolina and transportation difficulties for economically disadvantaged families. Due to a history of under-treating pain in SCD it is also critical that psychological and medical treatments are presented in an integrated manner so that these approaches are viewed as complimentary, not mutually exclusive, approaches to pain management. Finally, we believe the same implementation issues for improving the use of behavioral coping skills are also important for improving adherence to medication protocols for appropriate home-based pain management. The purpose of this proposal is to develop, implement, and evaluate a pain management protocol that uses portable electronic devices and other technologies to increase the practice of psychosocial pain management techniques, improve adherence to the overall biopsychosocial pain management protocol, and improve the clinician's ability to track progress with fewer office visits. In addition to addressing important dissemination issues, by embedding methods to assess for adherence into the technology it will be possible to continuously evaluate and modify protocol efficacy, resulting in a product that is effective, empirically sound, and flexible. Participants will be randomly assigned to the intervention or waitlist control condition. Those on the waitlist condition will receive the same study procedures after a 2 month wait periods. We anticipate that the intervention will result in better pain management and less impairment in the participants.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria mandate that the families selected demonstrate adherence with standard SCD treatment as indicated by reliable attendance to clinic visits, and chart notes demonstrating adherence to prescribed medical care (e.g., follow-through with required specialist visits and appointments for diagnostic procedures). Participants must have had at least 1 major pain episode or 3 minor pain episodes in the previous 6 months that resulted in functional impairment, such as reduced school attendance. Exclusion Criteria: - Individuals with developmental disabilities such as mental retardation, autism, and Down syndrome, severe cognitive limitations following stroke, or diagnoses of severe psychopathology will be excluded from participation as these disorders have the potential to confound the findings. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Cancer and Blood Disorder | Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
University of South Carolina | Pfizer |
United States,
McClellan CB, Schatz JC, Puffer E, Sanchez CE, Stancil MT, Roberts CW. Use of handheld wireless technology for a home-based sickle cell pain management protocol. J Pediatr Psychol. 2009 Jun;34(5):564-73. doi: 10.1093/jpepsy/jsn121. Epub 2008 Nov 23. — View Citation
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