Pain Management Protocol for Pediatric Sickle Cell Disease

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. Identifier: NCT00386048
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
University of South Carolina

Brief Summary:

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
Time Perspective: Prospective
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

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U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population are youths with sickle cell disease who are experiencing intermittent pain episodes that interfere with quality of life.

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.

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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 identifier (NCT number): NCT00386048

United States, South Carolina
Children's Cancer and Blood Disorder
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
University of South Carolina
Principal Investigator: Catherine B McClellan, Ph.D. University of South Carolina

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of South Carolina Identifier: NCT00386048     History of Changes
Other Study ID Numbers: SCD pain management protocol
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by University of South Carolina:
Cognitive Behavioral Therapy
Pediatric Sickle Cell Disease
Pain Management

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn