Functional Abdominal Pain DisordersNCT06653647
Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain
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 1 site 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
- 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Pilot Efficacy 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 and other surveys. Participants who qualify will be placed in one of two groups by chance:
Read more
- 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.
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, 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
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders, Functional Colonic Disease, Gastrointestinal Disease, Digestive System Diseases
- Being tested
- Guided Imagery Therapy
- Keywords
- abdominal pain, irritable bowel syndrome, recurrent abdominal pain
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Digestive System Diseases, Neurologic Manifestations, Signs and Symptoms, Digestive, 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) session 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 |
|---|---|---|
| Immediate Treatment | Active comparator | Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention. Receives: Behavioral: Guided Imagery Therapy |
| Delayed Treatment | Other | 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. Receives: Behavioral: Guided Imagery Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Frequency
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
Measured: 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)
Secondary outcomes (11)
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 (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)
Anxiety
Behavior Assessment System for Children, third edition, child self-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse
Measured: 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)
Anxiety
Behavior Assessment System for Children, third edition, parent proxy-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse
Measured: 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)
Depression
Behavior Assessment System for Children, third edition, child self-report Depression scale, t score ranges from 20 to 120, higher scores are worse
Measured: 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)
Depression
Behavior Assessment System for Children, third edition, parent-proxy report Depression scale, t scores ranges from 20 to 120, higher scores are worse
Measured: 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)
Somatization
Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse
Measured: 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)
Somatization
Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse
Measured: 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 Thoughts
Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse
Measured: 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 Thoughts
Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse
Measured: 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)
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 (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)
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 (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start18 Jul 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Qualified participants will be randomized into either the Delayed Treatment group or the Immediate Treatment Group. The Delayed Treatment Group will be observed for the first 8 weeks after randomization, and then outcome data will be reassessed through abdominal pain and stool diaries and other surveys. Then, this group will be crossed over to the treatment phase and given access to the mobile app intervention for another eight weeks. After this 8-week intervention phase, outcomes will be reassessed again via an abdominal pain and stooling diary and other surveys. 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
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
- Investigators
- John M Hollier, MD, MS, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653647
- Sponsor's protocol ID
- H-51406
- Other IDs
- K23DK120928
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
- ClinicalTrials.gov ID
- NCT06653647
- Acronym / sponsor ID
- H-51406
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders, Functional Colonic Disease, Gastrointestinal Disease, Digestive System Diseases
- Keywords
- abdominal pain, irritable bowel syndrome, recurrent abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 Oct 2024 (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 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.
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, 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Qualified participants will be randomized into either the Delayed Treatment group or the Immediate Treatment Group. The Delayed Treatment Group will be observed for the first 8 weeks after randomization, and then outcome data will be reassessed through abdominal pain and stool diaries and other surveys. Then, this group will be crossed over to the treatment phase and given access to the mobile app intervention for another eight weeks. After this 8-week intervention phase, outcomes will be reassessed again via an abdominal pain and stooling diary and other surveys. 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Active comparator | Behavioral: Guided Imagery TherapyParticipants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention. |
| Delayed Treatment | Other | Behavioral: Guided Imagery TherapyParticipants 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. |
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 (8 listed)
- 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
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) session via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain. | Behavioural | Delayed Treatment, Immediate Treatment |
Primary outcome
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
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
John M Hollier, MD, MS, MPH principal investigator
Baylor College of Medicine
1 site 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 1 site 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 8 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 10 Dec 2025.