About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous abdominal surgeries
Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
Autism
Significant development delay
Trial design
Single group
Treatments tested in this trial
Guided Imagery Therapy
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Abdominal Pain Frequency
Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
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
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
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
Sponsors and contacts
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