Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060619
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-08
Brief Title:
Migraine and Recurrent Abdominal Pain in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Treatment of Recurrent Pain Syndromes in Children
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
RECRUITING
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:
This study will evaluate a new model for assessing and treating migraine and recurrent abdominal pain in children The model combines behavioral techniques such as relaxation training with biologic components such as thermal biofeedback
Detailed Description:
Recurrent pain syndromes RPS are relatively common in pediatric populations Two of the most common types of RPS are recurrent abdominal pain RAP and migraine Similar patterns of pain are described in children with RAP and migraine and similar factors particularly stress may initiate both types of RPS
This study will assess a new biobehavioral model for evaluating and treating children with RPS This model relates precipitating intervening and functional status factors in chronic and recurring pain in children The model proposes that stress is a precipitant of pain This study will evaluate the model in children who receive therapy for RPS that is based on stress management strategies The therapy includes relaxation training cognitive coping skills training thermal biofeedback and parent education It will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy
Consenting participants will be randomized to receive either biobehavioral therapy or control therapy Participants will have 6 study visits over the course of 2 months The first study visit is an evaluation visit the remaining five study visits are treatment visits Participants will be followed for 24 months and will be asked to complete mail-in forms at Months 3 6 12 and 24
Participants will be recruited through local pediatricians pediatric neurologists and pediatric gastroenterologists Brochures about the study will be sent to these physicians to pass on to their patients informing them about the study Children in the control group will be recruited through Childrens Hospital outpatient clinics
This study will assess a new biobehavioral model for evaluating and treating children with RPS This model relates precipitating intervening and functional status factors in chronic and recurring pain in children The model proposes that stress is a precipitant of pain This study will evaluate the model in children who receive therapy for RPS that is based on stress management strategies The therapy includes relaxation training cognitive coping skills training thermal biofeedback and parent education It will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy
Consenting participants will be randomized to receive either biobehavioral therapy or control therapy Participants will have 6 study visits over the course of 2 months The first study visit is an evaluation visit the remaining five study visits are treatment visits Participants will be followed for 24 months and will be asked to complete mail-in forms at Months 3 6 12 and 24
Participants will be recruited through local pediatricians pediatric neurologists and pediatric gastroenterologists Brochures about the study will be sent to these physicians to pass on to their patients informing them about the study Children in the control group will be recruited through Childrens Hospital outpatient clinics
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