Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061230
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-22
Brief Title:
Relaxation Training to Decrease Pain and Improve Function in Adolescents With Cerebral Palsy
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:
Efficacy of Relaxation Training
Status:
UNKNOWN
Status Verified Date:
2003-04
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 examine the effectiveness of relaxation training for providing pain relief and improving physical and psychological functioning in youth with physical disabilities due to cerebral palsy
Detailed Description:
Chronic pain is a serious problem in many youths with disabilities There is a growing body of research supporting the efficacy of relaxation training for reducing chronic pain in adults Given this evidence there has been a growing interest in determining whether these findings also generalize to youths with chronic pain This study will address a significant gap in the medical literature by examining the efficacy of relaxation training for providing pain relief and improving function in youths with physical disabilities The study will evaluate the effects of relaxation training on global physiological arousal pain-site specific muscle tension and perceived control over pain Physiological arousal will be assessed via hand temperature and galvanic skin response Muscle tension will be assessed via surface EMG biofeedback recordings before during and after each treatment session Self-efficacy concerning pain control will be assessed via a modified Survey of Pain Attitudes and modified Coping Strategies Questionnaire
Sixty youth age range 10 to 20 years old with spastic type cerebral palsy CP will be randomly assigned to either the relaxation training group or a distraction control group Youths in the relaxation training group will be given eight sessions of autogenic relaxation training and will be asked to practice relaxation at home using audio tapes Youths in the distraction control group will receive eight sessions of distracting story-telling and will be asked to listen to age-appropriate audio tapes of stories at home Study visits are scheduled weekly for eight weeks Average pain intensity will be assessed with a numerical rating scale Secondary outcome measures include psychological functioning and pain interference with personal activities Medical services utilization will be assessed by asking the parent or guardian about any medications taken by the participant any illnesses or medical complications any medical treatments received and the frequency of health care visits Participants will be assessed at 1 3 6 9 and 12 months after treatment
Sixty youth age range 10 to 20 years old with spastic type cerebral palsy CP will be randomly assigned to either the relaxation training group or a distraction control group Youths in the relaxation training group will be given eight sessions of autogenic relaxation training and will be asked to practice relaxation at home using audio tapes Youths in the distraction control group will receive eight sessions of distracting story-telling and will be asked to listen to age-appropriate audio tapes of stories at home Study visits are scheduled weekly for eight weeks Average pain intensity will be assessed with a numerical rating scale Secondary outcome measures include psychological functioning and pain interference with personal activities Medical services utilization will be assessed by asking the parent or guardian about any medications taken by the participant any illnesses or medical complications any medical treatments received and the frequency of health care visits Participants will be assessed at 1 3 6 9 and 12 months after treatment
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