Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guided Imagery Therapy.
- Who it may be relevant to
- Registry conditions: Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Overview
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.
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, 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)
Interventions
- Behavioral Guided Imagery Therapy
Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) sessions via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Primary outcome measures
- Abdominal Pain Intensity [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
Secondary outcome measures (11)
- Abdominal Pain Frequency [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Anxiety [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Anxiety [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Depression [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Depression [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Somatization [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Somatization [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Pain Catastrophizing Thoughts [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Pain Catastrophizing Thoughts [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Health-Related Quality of Life [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
- Health-Related Quality of Life [Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Baylor College of Medicine/Texas Children's Hospital — Austin
- Baylor College of Medicine / Texas Children's Hospital — Houston
Identifiers
NCT: NCT07222943 · H-58306