Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386048
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2006-10-10
Brief Title:
Pain Management Protocol for Pediatric Sickle Cell Disease
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Home-based Pain Management Protocol for Children With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 clinicians 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
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 clinicians 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
Detailed Description:
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 clinicians 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 Childrens 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 childs 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 participants 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 patients 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 participants 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 Childrens Cancer and Blood Disorder Center at Palmetto Health and four DHEC Childrens 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 046 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
InclusionExclusion 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 eg 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
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 clinicians 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 Childrens 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 childs 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 participants 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 patients 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 participants 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 Childrens Cancer and Blood Disorder Center at Palmetto Health and four DHEC Childrens 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 046 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
InclusionExclusion 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None