Pain Management Protocol for Pediatric Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT00386048|
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : September 18, 2012
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.
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease||Behavioral: Brief Cognitive-Behavioral Pain Management Training|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Home-based Pain Management Protocol for Children With Sickle Cell Disease|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Standard of Care Observation Group
This group is randomized to continue their current medical management strategies for pain as recommended/prescribed by health care providers. Primary and secondary outcomes are collected at the same time intervals as the biopsychosocial intervention group.
Biopsychosocial Intervention Group
This group continues all standard of care procedures for managing pain and adds to this additional cognitive-behavioral treatment (CBT) strategies for managing pain. The intervention explicitly frames the CBT strategies as added, complimentary pain management methods to add to the standard of care treatment.
Behavioral: Brief Cognitive-Behavioral Pain Management Training
Participants complete a manualized, single session of training which includes: (A) education about the causes of sickle cell pain, (B) education about how the nervous system processes pain signals, and (C) explanations of how one can use cognitive and behavioral treatment (CBT) strategies to decrease the extent of pain experienced (all based on how the nervous system processes pain). Four specific CBT skills are taught and practiced by the participant (Progressive muscle relaxation, Controlled Deep Breathing, Imagery, and Distraction). The protocol explicitly emphasizes the use of CBT as a complimentary pain management tool to use in addition to the standard of care methods.
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): NCT00386048
|United States, South Carolina|
|Children's Cancer and Blood Disorder|
|Columbia, South Carolina, United States, 29203|
|Principal Investigator:||Catherine B McClellan, Ph.D.||University of South Carolina|