An interventional study of Guided Imagery Therapy in Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS) and Functional Gastrointestinal Disorders (FGIDs), sponsored by Baylor College of Medicine. Recruiting at 2 sites in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
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:
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 63 is close to the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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Exclusion Criteria:
Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.
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.
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
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Abdominal Pain Frequency
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Post-intervention (immediately after 8-week intervention)
Plan to share: Undecided
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