Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Abdominal Pain Frequency
研究概览
简要总结
Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.
Participants will complete a baseline abdominal pain and stooling diary to determine eligibility and other surveys. Participants who qualify will be placed in one of two groups by chance:
- Immediate Treatment Group
- Delayed Treatment Group
After randomization, the Immediate Treatment Group will get immediate access to the guided imagery therapy (GIT) mobile app intervention. This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary and other psychometric surveys at the end of this intervention period.
After randomization, the Delayed Treatment group will be observed as they wait 8 weeks without app access. During this phase, these participants will continue to treat their abdominal pain in their usual fashion. After the end of this waiting period, participants will complete another abdominal pain and stooling diary and psychometric surveys again before gaining access to the GIT mobile app intervention. As noted previously, the mobile app intervention will ask participants to listen to a 10- to 15-minute GIT session 5 out of 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Another abdominal pain and stooling diary and other psychometric surveys will be collected at the end of this app intervention.
详细描述
After fully disclosing the study design, intervention options, randomization scheme, and potential side effects of the interventions, caregivers and their children will document their respective informed consent and assent electronically. REDCap is a secure web application designed for surveys and databases. All data captured through REDCap will be encrypted and transmitted securely to HIPAA-compliant institutional servers for storage.
Participants and their caregivers will complete the following surveys at baseline, second baseline phase (delayed treatment group only 8 weeks after baseline), and immediately post-therapy (delayed treatment group 16 weeks after baseline and immediate treatment group 8 weeks after baseline) through REDCap:
- 2-week Abdominal Pain and Stooling Diary
- Children's Somatic Symptoms Inventory (child self-report and parent proxy-report)
- Pain Catastrophizing Scale - Child Version
- Pain Catastrophizing Scale - Parent Version
- Pediatric Quality of Life Inventory 4.0 Generic Core (child self-report and parent proxy-report)
- Behavior Assessment System for Children 3rd Ed (child self-report and parent proxy-report)
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
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Texas Children's Pediatrics patients 7 to 12 years old at enrollment
- •A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary
- •Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.
排除标准
- •Prior participation in principal investigator's related feasibility or usability study
- •Previous abdominal surgeries
- •Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
- •Significant development delay
- •Psychosis
- •Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain
- •Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)
结局指标
主要结局
Abdominal Pain Frequency
时间窗: Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
次要结局
- Abdominal Pain Intensity(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
- Anxiety(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
- Pain Catastrophizing Thoughts(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
- Depression(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
- Somatization(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
- Health-Related Quality of Life(Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline))
研究者
John M Hollier
Assistant Professor
Baylor College of Medicine