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: * 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Baylor College of Medicine/Texas Children's Hospital
Austin, Texas, United States
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States
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, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Abdominal Pain Frequency
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Anxiety
Behavior Assessment System for Children, third edition, child self-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Anxiety
Behavior Assessment System for Children, third edition, parent proxy-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Depression
Behavior Assessment System for Children, third edition, child self-report Depression scale, t score ranges from 20 to 120, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Depression
Behavior Assessment System for Children, third edition, parent-proxy report Depression scale, t scores ranges from 20 to 120, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Somatization
Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Somatization
Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Pain Catastrophizing Thoughts
Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
Pain Catastrophizing Thoughts
Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse
Time frame: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
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, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
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, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment
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