Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain
NCT ID: NCT06653647
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2025-07-18
2025-11-30
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Those qualified participants randomized to the Immediate Treatment Group will be given access to the mobile app intervention for eight weeks. At the end of the eight weeks, outcome measures will be reassessed through an abdominal pain and stooling diary and other surveys.
TREATMENT
NONE
Study Groups
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Immediate Treatment
Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.
Guided Imagery Therapy
Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) session via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Delayed Treatment
Participants randomized to the Delayed Treatment arm will be placed on waitlist status and will not have any intervention from weeks 3 to 10. Participants will continue their usual care for their abdominal pain during this time. Then, this study arm will cross over to the guided imagery therapy mobile application intervention from weeks 11 to 18.
Guided Imagery Therapy
Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) session via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Interventions
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Guided Imagery Therapy
Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) session via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous abdominal surgeries
* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
* Autism
* 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)
7 Years
12 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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John M Hollier
Assistant Professor
Principal Investigators
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John M Hollier, MD, MS, MPH
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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H-51406
Identifier Type: -
Identifier Source: org_study_id
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