Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorBaylor College of Medicine

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Guided Imagery Therapy

    Behavioral

    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.

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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