Abdominal Pain/ Discomfort, Functional Abdominal Pain Disorders, Functional Dyspepsia, Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder, Irritable Bowel Syndrome (IBS), Pain
Conditions
Keywords
abdominal pain, irritable bowel syndrome
Brief 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. 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)
Interventions
BEHAVIORALGuided 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.
Sponsors
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain Intensity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain Frequency | Baseline and Post-intervention (immediately after 8-week intervention) | Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary |
| Anxiety | Baseline and Post-intervention (immediately after 8-week intervention) | Patient-Reported Outcomes Measurement Information System (PROMIS), Pediatric Anxiety Short Form 8a, t score ranges from approximately 36 to 83, higher scores are worse |
| Depression | Baseline and Post-intervention (immediately after 8-week intervention) | 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 |
| Somatization | Baseline and Post-intervention (immediately after 8-week intervention) | Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse |
| Pain Catastrophizing Thoughts | Baseline and Post-intervention (immediately after 8-week intervention) | Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse |
| Health-Related Quality of Life | Baseline and Post-intervention (immediately after 8-week intervention) | Pediatric Quality of Life Inventory Generic Core Scales 4.0 child self-report, raw score ranges from 0 to 100, higher scores are better |
Countries
United States
Contacts
CONTACTHollier, MD
Outcome results
None listed