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NCT Number: NCT07222943

Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

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.

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Key information

Conditions

Functional Abdominal Pain Disorders Abdominal Pain Abdominal Pain/ Discomfort Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Functional Dyspepsia Functional Gastrointestinal Disorders (FGIDs) Gastrointestinal Diseases Gastrointestinal and Digestive Disorder Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine/Texas Children's Hospital, Austin, Texas, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Guided Imagery Therapy

Behavioral

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 outcomes

  1. Abdominal Pain Intensity

    Time frame: 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

Secondary outcomes

  1. Abdominal Pain Frequency

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary

  2. Anxiety

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Behavior Assessment System for Children, third edition, child self-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse

  3. Anxiety

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Behavior Assessment System for Children, third edition, parent proxy-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse

  4. Depression

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Behavior Assessment System for Children, third edition, child self-report Depression scale, t score ranges from 20 to 120, higher scores are worse

  5. Depression

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Behavior Assessment System for Children, third edition, parent-proxy report Depression scale, t scores ranges from 20 to 120, higher scores are worse

  6. Somatization

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse

  7. Somatization

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse

  8. Pain Catastrophizing Thoughts

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse

  9. Pain Catastrophizing Thoughts

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse

  10. Health-Related Quality of Life

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Pediatric Quality of Life Inventory Generic Core Scales 4.0 child self-report, raw score ranges from 0 to 100, higher scores are better

  11. Health-Related Quality of Life

    Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

    Pediatric Quality of Life Inventory Generic Core Scales 4.0 parent-proxy report, raw score ranges from 0 to 100, higher scores are better

Study contacts

Contact information is provided by the study sponsor or research team.

Hollier, MD

CONTACT

[email protected]

832-824-3814

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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