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Completed

NCT Number: NCT06653647

Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

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.

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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 Colonic Disease Functional Gastrointestinal Disorders Gastrointestinal Disease Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Nervous System Diseases Neurologic Manifestations Neurological 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

Houston, Texas, 77030, United States

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, 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)

Who can participate

Healthy volunteers accepted: No

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

Study staff will enroll children with functional abdominal pain disorders and their primary caregiver for this study.

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)
  • 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) session 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 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

  1. Abdominal Pain Intensity

    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 daily abdominal pain severity measured on a 0-10 (10 is most severe) ordinal scale from a self-report 2-week abdominal pain diary

  2. Anxiety

    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)

    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 (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)

    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 (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)

    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 (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)

    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 (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)

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

  7. Somatization

    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)

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

  9. Pain Catastrophizing Thoughts

    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)

    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 (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)

    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 (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)

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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Dec 10, 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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