Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Abdominal Pain Disorders
- Sponsor
- Baylor College of Medicine
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Abdominal Pain Frequency
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
John M Hollier
Assistant Professor
Baylor College of Medicine
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Abdominal Pain Frequency
Time Frame: 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
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))