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Behavioral Intervention

Guided Imagery Therapy for Abdominal Pain

N/A

Recruiting

Led By John M Hollier, MD, MS, MPH

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Texas Children's Pediatrics patients 7 to 12 years old at enrollment

Weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0 to 10 point scale (10 is most severe) from a self-report 2-week abdominal pain diary

Must not have

Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)

Previous abdominal surgeries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (both groups), second baseline (delayed treatment group only, 8 weeks after baseline), and post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test how well pre-recorded guided imagery therapy sessions, delivered via a mobile app on a smartphone or tablet, help in reducing chronic abdominal pain in children. Participants will be divided into

Who is the study for?

This trial is for children with chronic abdominal pain due to conditions like IBS or functional gastrointestinal disorders. They must be able to use a mobile app and complete diaries and surveys. Specific eligibility details are not provided, but typically there would be age limits and requirements for diagnosis.

What is being tested?

The trial tests if a mobile app delivering Guided Imagery Therapy (GIT) can help ease abdominal pain in children. Participants are randomly placed into two groups: one starts using the GIT app immediately, while the other waits 8 weeks before starting.

What are the potential side effects?

Guided Imagery Therapy is generally considered safe with minimal risk of side effects since it's a non-invasive psychological therapy involving listening to calming sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a patient at Texas Children's Pediatrics, aged 7-12.

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My worst daily abdominal pain score averages over 3 in the last 2 weeks.

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I have been diagnosed with a functional abdominal pain disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like cystic fibrosis that causes abdominal pain.

Select...

I have had surgery in my abdomen before.

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I have seen blood in my stool.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (both groups), second baseline (delayed treatment group only, 8 weeks after baseline), and post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (both groups), second baseline (delayed treatment group only, 8 weeks after baseline), and post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (both groups), second baseline (delayed treatment group only, 8 weeks after baseline), and post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abdominal Pain Frequency

Secondary study objectives

Abdominal Pain Intensity

Anxiety

Depression

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Delayed TreatmentExperimental Treatment1 Intervention

Participants randomized to the Delayed Treatment arm will be placed on waitlist status and will not have any intervention from weeks 3 to 10. Participants will continue their usual care for their abdominal pain during this time. Then, this study arm will cross over to the guided imagery therapy mobile application intervention from weeks 11 to 18.

Group II: Immediate TreatmentActive Control1 Intervention

Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.

0 / 6Eligibility criteria met