Headstrong Intervention for Recurrent Pediatric Headache

顽固干预治疗复发性小儿头痛

• 批准号: 7100280
• 负责人: MICHAEL Andrew RAPOFF
• 金额: $ 16.75万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7100280
• 关键词: DVD /CD ROM; analgesia; behavioral /social science research tag; child with disability; clinical research; clinical trials; cognitive behavior therapy; computer assisted patient care; computer human interaction; cost effectiveness; data collection methodology /evaluation; disease /therapy duration; headache; human subject; human therapy evaluation; longitudinal human study; mental health education; middle childhood (6-11); migraine; muscle contraction; patient care management; pediatrics; personal log /diary; psychological stressor; quality of life; self care

DESCRIPTION (provided by applicant): Recurrent pediatric headache is a chronic pain syndrome affecting more than two million American children and often resulting in significant functional disability and debilitation. Moreover, this syndrome represents a substantial cost to the patient's family and the health care system. The goal of the present study is to evaluate the efficacy of a new cost-effective approach to the treatment of recurrent pediatric headache that allows children to learn how to self-manage their headaches via a CD-ROM program (called "Headstrong TM"). This grant proposal is being submitted in response to PA-01-115, which called for research seeking to identify and refine innovative and effective treatment strategies for specific pain conditions. A randomized trial will be used to evaluate the effectiveness of the Headstrong TM intervention. One-hundred and eight (108) pediatric patients, ages 7-12 years, with a diagnosed recurrent migraine, muscle-contraction, or chronic daily headache syndrome will be enrolled in the study. After enrollment, each patient's baseline headache frequency, duration, and intensity will be assessed for one month using headache diaries. During this one-month baseline period, we will also collect data to examine headache-related disability and health related quality of life. After baseline, patients will be randomly assigned to the standard medical care plus Headstrong TM intervention or the standard medical care plus Education condition (also a CD-ROM program with information about recurrent headaches, such as types, etiology, and triggers). Both groups will work through modules in their respective programs over the course of one month. Dependent measures will then continue to be collected at one-month post-treatment and three-, six-, and twelve-month post-treatment follow-up. The primary study outcome will be headache frequency, duration, and intensity as measured by daily headache diaries. Secondary endpoints will include headache-related disability outcomes and quality of life.

描述（由申请人提供）：经常性的小儿头痛是一种慢性疼痛综合征，影响了200万以上美国儿童，并且经常导致功能障碍和衰弱。此外，该综合征对患者的家庭和医疗保健系统代表了巨大的成本。本研究的目的是评估一种新的具有成本效益的方法来治疗复发性儿科头痛的功效，该方法使儿童能够通过CD-ROM程序学习如何自我管理自己的头痛（称为“ Headstrong TM”）。该赠款提案正在响应PA-01-115提交，该提案呼吁进行研究，以识别和完善特定疼痛状况的创新和有效的治疗策略。一项随机试验将用于评估头肌TM干预的有效性。该研究将纳入一百八岁（108）个儿科患者，年龄在7-12岁之间，诊断为复发性偏头痛，肌肉收缩或慢性每日头痛综合征。入学后，使用头痛日记评估每个患者的基线头痛频率，持续时间和强度。在这个一个月的基准期间，我们还将收集数据以检查与头痛相关的残疾和与健康有关的生活质量。基线后，将将患者随机分配到标准医疗服务以及标准医疗服务以及教育状况（也是CD-ROM计划），其中包含有关经常性头痛的信息，例如类型，病因和触发者）。两个小组将在一个月的时间内通过各自计划中的模块进行工作。然后，将继续在治疗后一个月以及在治疗后的三个月，六个月和十二个月后继续收集依赖措施。主要的研究结果将是通过每日头痛日记来衡量的头痛频率，持续时间和强度。次要终点将包括与头痛相关的残疾结果和生活质量。