The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
研究概览
简要总结
The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.
详细描述
Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.
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
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who speak English
- •diagnosis with Recurrent abdominal pain
排除标准
- •lactose intolerance, urinary tract infections, or recent head trauma;
- •the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
- •currently receiving other treatment for recurrent abdominal pain;
- •the receipt of a recent and related surgical procedure;
- •children who met criteria for depression or anxiety disorder
研究组 & 干预措施
Biofeedback
heart rate variability biofeedback
干预措施: Biofeedback (Behavioral)
Behavioral
Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements
干预措施: Behavioral Protocol (Behavioral)
结局指标
主要结局
The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
时间窗: 3 Months
次要结局
- A measurable secondary outcome will be changes in heart rate variability(3 Months)