Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.
详细描述
An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.
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
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate in English
- •Age 11-17 years
- •Pain present for at least 3 months duration
- •Pain occurs at least 1 time per week and interferes with daily functioning
- •Pain is not related to a chronic disease
- •Receiving evaluation or treatment in a pediatric pain clinic
- •Has access to a computer, the Internet, and a phone
排除标准
- •A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
- •Non-English speaking
- •More than 4 sessions of CBT for pain management in the 6 months prior to the time of screening.
研究组 & 干预措施
Online Behavioral Intervention
In addition to standard medical care, children and parents in the online behavioral intervention will receive access to the full web-based program including education about chronic pain, training in behavioral and cognitive coping skills, instruction in increasing activity participation, and education about pain behaviors and parental operant strategies using an engaging, interactive format on the Internet.
干预措施: Online Behavioral Intervention (Behavioral)
Online Patient Education
The Online Patient Education group will serve as an attention control condition. In addition to standard medical care, children and parents will be provided with access to a modified version of the study website that will provide information from publicly available educational websites about pediatric chronic pain management.
干预措施: Education: Online Patient Education (Other)
结局指标
主要结局
Pain intensity
时间窗: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Children will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS) with anchors of 0= no pain to 10= worst pain (McGrath et al., 2008). Mean average intensity of the pain reported will serve as primary pain measure.
Activity limitations
时间窗: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Child report of activity limitations will be assessed using the prospective version of the Child Activity Limitations Interview (Palermo, Witherspoon, Valenzuela, \& Drotar, 2004), which includes 8 activities that children identify as important in their day-to-day lives that are impacted by pain. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Children will provide ratings daily for 7 days on their online diaries at each assessment period. Mean activity limitations across the reporting period is used in analyses.
次要结局
- Sleep Quality(pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up)
- Depression and pain-specific anxiety(pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up)
- Treatment Satisfaction(Immediately Post-Treatment, 6-month follow-up, 12-month follow-up)
- Parental Response to Pain Behavior(pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up)
- Health service Use(pre-treatment, 12-month follow-up)
- Miscarried Helping(pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up)
研究者
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital