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Home-based Pain Management Protocol for Children With Sickle Cell Disease


N/A
8 Years
18 Years
Not Enrolling
Both
Sickle Cell Disease

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Trial Information

Home-based Pain Management Protocol for Children With Sickle Cell Disease


"Home-Based Pain Management Protocol for Children with Sickle Cell Disease"

BACKGROUND: 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.

PURPOSE: The purpose of this research is to implement and evaluate a pain management
protocol that uses portable electronic devices (PDA) 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.

STUDY PROCEDURES:

Recruitment and Assignment to Study Conditions. Families will be approached as part of their
routine psychosocial screenings currently conducted at the Children's Cancer and Blood
Disorder Center. Parental informed consent and child assent will be obtained from families
who meet inclusion criteria and agree to participate. Next, participants will be randomly
assigned to waitlist control or intervention groups through the use of a random assignment
procedure. The researcher will explain details of the participation incentive system to the
families at this time, including the number of coupons assigned for each phase of study
completion and how to redeem coupons for toys and gift cards. All participants (waitlist
control group and intervention group) will complete the initial measures: Background
Information Questionnaire ; Structured Pain History Interview - Parent and Child Forms;
Coping Strategies Questionnaire (CSQ); Pediatric Quality of Life Inventory (PEDS-QL);
Pediatric Pain Questionnaire (PPQ); Child Health Locus of Control during the initial meeting
and the second set of measures (CSQ, PEDS-QL and PPQ) 4 weeks after the initial meeting.

Cognitive-Behavioral Training. Following completion of the intake measures, families in the
intervention condition will be provided education on pain medication use and explanation of
active versus passive methods of coping with pain and the cognitive-behavior techniques will
be introduced (Progressive Muscle Relaxation, Deep Breathing, Guided imagery and
Distraction). These techniques will be tailored to the child's preferences and recorded onto
the PDA.

Next, the researcher will review with the family the pain flow chart, how to complete the
Daily Pain and Activity Diary (DPAD), and use the PDA and Pain Management software.
Participants and their parents will be provided with detailed instructions regarding care of
PDA, who to contact if device is broken or lost, policy on continued participation if device
is lost, and a padded addressed stamped envelope to return the PDA should it require
attention. Three days after the initial visit families will be contacted to answer questions
and ensure implementation of skills.

Families will also receive a weekly telephone contact at a pre-arranged time to address any
difficulties with protocol implementation. Pain diaries and frequency of skills practice
will be electronically downloaded approximately every three days using wireless
synchronization built into the PDA devices. One month following the initial session, all
participants (waitlist and intervention groups) will complete the PPQ, PEDS-QL and CSQ
outcome measures. Two months after the initial session, intervention participants will
complete outcome measures, including PPQ, PEDS-QL, CSQ and Protocol Evaluation Form (PEF).
Six months after the initial session, intervention participants will complete the follow-up
measures, including child report on the CSQ, and parent and child report on the PPQ and
PEDS-QL. At this time the participant's school will be contacted to obtain school attendance
records so as to document absences due to illness over the previous year and participants
medical records will be reviewed to examine patient's disease severity over the course of
their study participation time and their lives (Medical Record Review Form). Participants in
the waitlist control group will start participation in the intervention at the two month
point, and follow the procedures outlined above for the intervention condition.

Concurrent Validity Study Procedures. Assessment of pain experience will be obtained for
study participants undergoing routine venipuncture as part of their clinic visit
co-occurring with study entry and study completion. Observational, physiological response,
parent-report, and self-report of pain experience will be obtained to provide convergent
validity for measures of pain report. A brief measure of medical coping style, the Child
Approach-Avoidance Rating Scale (CAARS; Appendix J) will be included to assess for shifts in
coping strategies employed by the participant during painful procedures. Participants and
parents will report on child pain experience before, during, and after the routine
venipuncture that is part of their clinic visit on the day of initial contact. Participant
response to routine venipuncture will also be captured via video recording to allow for an
in-depth analysis of observable pain behaviors. Pre-procedural heart rate will be taken at
three intervals: when the patient is first seen for the clinic visit, immediately prior to
the venipuncture, and immediately following the venipuncture. Additionally, small extra vial
of blood will be obtained (5mL) to measure the participant's level of endothelin-1, a
biological marker of pain. This extra vial of blood will not require an additional needle
stick. Finally, the medical records of all participants will be reviewed to obtain
information about disease course.

SUBJECT POPULATION:

Participants will include up to 50 children and adolescents with SCD ranging between the
ages of 8 to 18 years of age and their primary caregivers. Participants will be recruited
from the Children's Cancer and Blood Disorder Center at Palmetto Health and four DHEC
Children's Rehabilitative Services sites (Orangeburg, Columbia, Florence and Sumter).
Reviews of behavioral interventions for rheumatoid arthritis or chronic low back pain have
indicated typical treatment effect sizes for pain experience and coping of d = 0.46 or
greater (Astin et al., 2002; van Tulder et al., 2001). Using this value as a basis for
computing study power (with an alpha level of .05) the study has an expected power of .80
with a sample size of 50 participants.

Inclusion/Exclusion 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. Finally, 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.

CONFIDENTIALITY: To minimize threats to confidentiality, only investigators will have access
to participant data. For data management purposes and confidentiality, subjects will be
given a unique identifier to use when recording data and electronically transmissions of
data. This arrangement minimizes risk to loss of patient confidentiality. All study staff,
including research assistants who may enter data, will be required to complete and pass the
University of South Carolina Human Subjects on-line tutorial prior to commencing their work
on this research project. All data will be stored in a locked file cabinet in the
investigators office at Palmetto Health.

EXPECTED RESULTS AND IMPLICATIONS: We anticipate that the intervention will result in better
pain management and less impairment in the participants. These data will be used to seek
funding for a larger-scale study and in the development of interventions to decrease the
impact of pain on the lives of individuals with SCD.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Catherine B McClellan, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

SCD pain management protocol

NCT ID:

NCT00386048

Start Date:

November 2006

Completion Date:

August 2012

Related Keywords:

  • Sickle Cell Disease
  • Cognitive Behavioral Therapy
  • Pediatric Sickle Cell Disease
  • Pain Management
  • Anemia, Sickle Cell

Name

Location

Children's Cancer and Blood DisorderColumbia, South Carolina  29203