Functional Abdominal Pain DisordersNCT07222943
Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
A study testing Guided Imagery Therapy in people with Functional Abdominal Pain Disorders and Irritable Bowel Syndrome (IBS), run by Baylor College of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs)
- What is being tested?
- Guided Imagery Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baylor College of Medicine/Texas Children's Hospital
Austin, Texas, 78759
Hollier, MD, 832-824-3814, jmhollie@bcm.edu
- Recruiting
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
Hollier, MD, 832-824-3814, jmhollie@bcm.edu
About this study
Official title: Open-Labelled 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.
Read the 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)
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder, Abdominal Pain/ Discomfort, Pain
- Being tested
- Guided Imagery Therapy
- Keywords
- abdominal pain, irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Digestive System Diseases, Pain, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention. Receives: Behavioral: Guided Imagery Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Intensity
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
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Secondary outcomes (11)
Abdominal Pain Frequency
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS), Pediatric Anxiety Short Form 8a, t score ranges from approximately 36 to 83, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS), Parent Proxy Anxiety Short Form 8a, t score ranges from approximately 36 to 84, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Depression
Patient-Reported Outcomes Measurement Information System (PROMIS), Pediatric Depressive Symptoms Short Form 8a, t score ranges from approximately from 38-82, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Depression
Patient-Reported Outcomes Measurement Information System (PROMIS), Parent Proxy Depressive Symptoms Short Form 6a, t score ranges from approximately from 36 to 85, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Somatization
Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Somatization
Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Pain Catastrophizing Thoughts
Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Pain Catastrophizing Thoughts
Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Health-Related Quality of Life
Pediatric Quality of Life Inventory Generic Core Scales 4.0 child self-report, raw score ranges from 0 to 100, higher scores are better
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Health-Related Quality of Life
Pediatric Quality of Life Inventory Generic Core Scales 4.0 parent-proxy report, raw score ranges from 0 to 100, higher scores are better
Measured: Baseline and Post-intervention (immediately after 8-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start8 Sep 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Qualified participants 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. we will also assess these same outcomes 3 months -post-treatment.
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M Hollier, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222943
- Sponsor's protocol ID
- H-58306
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
- ClinicalTrials.gov ID
- NCT07222943
- Acronym / sponsor ID
- H-58306
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder, Abdominal Pain/ Discomfort, Pain
- Keywords
- abdominal pain, irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Qualified participants 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. we will also assess these same outcomes 3 months -post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Guided Imagery TherapyParticipants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous abdominal surgeries
- Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
- Autism
- Significant development delay
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery TherapyParticipants 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. | Behavioural | Treatment |
Primary outcome
Abdominal Pain Intensity
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
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
11 secondary outcomes
Abdominal Pain Frequency
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Anxiety
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Anxiety
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Depression
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Depression
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Somatization
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Somatization
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Pain Catastrophizing Thoughts
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Pain Catastrophizing Thoughts
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Health-Related Quality of Life
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Health-Related Quality of Life
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery Therapy in people with Functional Abdominal Pain Disorders and Irritable Bowel Syndrome (IBS), run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hollier, MD (832-824-3814, GITgoStudy@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Pain Intensity (time frame: Baseline and Post-intervention (immediately after 8-week intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.