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临床试验/NCT00061230
NCT00061230Unknown不适用

Efficacy of Relaxation Training

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebral palsy
  • Referred by the study physician
  • Chronic cerebral palsy-related pain for at least 3 months prior to study entry. The pain needs to have an average daily occurrence of 3 on a 0 to 10 scale, where 0 is no pain and 10 is extreme pain.
  • Primary language is English

排除标准

  • Acute painful conditions
  • Cognitive impairment as determined by a score < 12 on the modified Mini-Mental Status Exam

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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