Open-Labelled Feasibility Study 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
- 招募中
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Abdominal Pain Intensity
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, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.
This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.
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, immediately post-therapy (8 weeks after baseline), and 3 months post-treatment 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
- Na
- 干预模型
- Single Group
- 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
- •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)
研究组 & 干预措施
Treatment
Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.
干预措施: Guided Imagery Therapy (Behavioral)
结局指标
主要结局
Abdominal Pain Intensity
时间窗: Baseline and Post-intervention (immediately after 8-week intervention)
Average daily abdominal pain severity measured on a 0-10 (10 is most severe) ordinal scale from a self-report 2-week abdominal pain diary
Abdominal Pain Intensity
时间窗: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Average daily abdominal pain severity measured on a 0-10 (10 is most severe) ordinal scale from a self-report 2-week abdominal pain diary
次要结局
- Abdominal Pain Frequency(Baseline and Post-intervention (immediately after 8-week intervention))
- Anxiety(Baseline and Post-intervention (immediately after 8-week intervention))
- Depression(Baseline and Post-intervention (immediately after 8-week intervention))
- Somatization(Baseline and Post-intervention (immediately after 8-week intervention))
- Pain Catastrophizing Thoughts(Baseline and Post-intervention (immediately after 8-week intervention))
- Health-Related Quality of Life(Baseline and Post-intervention (immediately after 8-week intervention))
- Anxiety(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
- Health-Related Quality of Life(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
- Abdominal Pain Frequency(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
- Depression(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
- Somatization(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
- Pain Catastrophizing Thoughts(Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment)
研究者
John M Hollier
Associate Professor
Baylor College of Medicine