A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in abdominal pain severity
研究概览
简要总结
Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.
详细描述
Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with CP or ARP
- •ages 10-19 years
- •at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
- •access to the Internet on any web-enabled device
排除标准
- •non-English speaking
- •inability to read at the 5th grade level due to learning problem or developmental delay
- •children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
- •patients with Shwachman-Bodian-Diamond Syndrome
- •Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
- •anticipated surgery (TPIAT or other) during study participation
研究组 & 干预措施
Web-based CBT (WebMAP)
Receives access to WebMAP
干预措施: Web-based CBT (Behavioral)
Pain Education (WebED)
Receives access to WebED
干预措施: Pain Education (Behavioral)
结局指标
主要结局
Change in abdominal pain severity
时间窗: Baseline, 12 weeks, 6 months
The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity.
Change in Adolescent Abdominal Pain Severity
时间窗: Baseline, 12 weeks, 6 months
The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.
次要结局
- Change in pain-related disability(Baseline, 12 weeks, 6 months)
- Change in pain interference(Baseline, 12 weeks, 6 months)
- Change in health-related quality of life(Baseline, 12 weeks, 6 months)
- Change in opioid use(Baseline, 12 weeks, 6 months)
- Change in health service utilization(Baseline, 6 months)
- Change in emotional distress(Baseline, 12 weeks, 6 months)
- Change in pain self-efficacy(Baseline, 12 weeks, 6 months)
- Change in parent impact of pain(Baseline, 12 weeks, 6 months)
- Change in Pain-related Disability(Baseline, 12 weeks, 6 months)
- Change in Health-related Quality of Life(Baseline, 12 weeks, 6 months)
- Change in Emotional Distress(Baseline, 12 weeks, 6 months)
- Change in Opioid Use(Baseline, 6 months)
- Change in Pain Self-efficacy(Baseline, 12 weeks, 6 months)
- Change in Parent Impact of Pain(Baseline, 12 weeks, 6 months)
- Change in Pain Interference(Baseline, 12 weeks, 6 months)
- Change in Health Service Utilization(Baseline, 6 months)
研究者
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital