52 Participants Needed

Guided Imagery Therapy for Abdominal Pain

LC
Overseen ByLaurel Cavallo
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It mentions that participants will continue their usual care for abdominal pain, so it's likely you can keep taking your current meds.

What data supports the effectiveness of the treatment Guided Imagery Therapy for Abdominal Pain?

Research shows that guided imagery, a technique where you visualize calming images, can significantly reduce pain in children with recurrent abdominal pain and improve recovery after surgery. It has also been effective in managing pain for cancer patients and those with irritable bowel syndrome.12345

Is guided imagery therapy safe for humans?

Guided imagery therapy is generally considered safe for humans, as it is a non-invasive technique that uses imagination to help reduce pain and anxiety. It has been used in various settings, including for children with abdominal pain and patients with chronic pain, without reported safety concerns.13678

How is Guided Imagery Therapy different from other treatments for abdominal pain?

Guided Imagery Therapy is unique because it uses a mobile app to help patients use their imagination to connect their mind and body, which can reduce pain and anxiety without medication. This approach is particularly novel for children with abdominal pain, as it provides an accessible, non-drug option that can be used at home.13679

What is the purpose of 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 and other surveys. Participants who qualify will be placed in one of two groups by chance:* Immediate Treatment Group* Delayed Treatment GroupAfter randomization, the Immediate Treatment Group will get immediate access to the guided imagery therapy (GIT) mobile app intervention. This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary and other psychometric surveys at the end of this intervention period.After randomization, the Delayed Treatment group will be observed as they wait 8 weeks without app access. During this phase, these participants will continue to treat their abdominal pain in their usual fashion. After the end of this waiting period, participants will complete another abdominal pain and stooling diary and psychometric surveys again before gaining access to the GIT mobile app intervention. As noted previously, the mobile app intervention will ask participants to listen to a 10- to 15-minute GIT session 5 out of 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Another abdominal pain and stooling diary and other psychometric surveys will be collected at the end of this app intervention.

Research Team

JM

John M Hollier, MD, MS, MPH

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

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
I am a patient at Texas Children's Pediatrics, aged 7-12.
My worst daily abdominal pain score averages over 3 in the last 2 weeks.
See 1 more

Exclusion Criteria

I have a condition like cystic fibrosis that causes abdominal pain.
Prior participation in principal investigator's related feasibility or usability study
Significant development delay
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (virtual)

Immediate Treatment

Participants in the Immediate Treatment group receive guided imagery therapy via a mobile app for 8 weeks

8 weeks
Weekly virtual check-ins

Delayed Treatment

Participants in the Delayed Treatment group wait for 8 weeks before starting the guided imagery therapy

8 weeks
Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (virtual)

Treatment Details

Interventions

  • Guided Imagery Therapy Mobile Application
Trial Overview 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.
Participant Groups
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.

Guided Imagery Therapy Mobile Application is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Guided Imagery Therapy for:
  • Functional Abdominal Pain Disorders
  • Chronic Abdominal Pain
🇪🇺
Approved in European Union as Guided Imagery Therapy for:
  • Functional Abdominal Pain Disorders
  • Chronic Abdominal Pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

In a study of 22 children aged 5-18, those who learned guided imagery with progressive muscle relaxation experienced a significantly greater reduction in the number of days with abdominal pain compared to those who only practiced breathing exercises, with improvements noted at one and two months after the intervention.
Guided imagery not only reduced pain days but also decreased missed activities due to pain, suggesting it is an effective, noninvasive therapy for recurrent abdominal pain in children, with a notable increase in the number of children achieving a pain-free status.
Evaluation of guided imagery as treatment for recurrent abdominal pain in children: a randomized controlled trial.Weydert, JA., Shapiro, DE., Acra, SA., et al.[2022]
In a study involving 52 pediatric surgical patients, those who practiced guided imagery experienced significantly lower postoperative pain ratings and shorter hospital stays compared to the control group.
The use of guided imagery also reduced state anxiety in the experimental group, while anxiety levels increased in the control group after surgery, highlighting the psychological benefits of this technique.
The effects of hypnosis/guided imagery on the postoperative course of children.Lambert, SA.[2022]
Guided imagery with relaxation (GIR) is a promising mind-body therapy that may help reduce chronic pain in cancer patients, addressing a significant issue in their quality of life.
The study qualitatively compared the experiences of cancer patients using GIR versus those who engaged in planned rest, highlighting the potential benefits of GIR in pain management.
Active Despite Pain: Patient Experiences With Guided Imagery With Relaxation Compared to Planned Rest.Adeola, MT., Baird, CL., Sands, L., et al.[2019]

References

Evaluation of guided imagery as treatment for recurrent abdominal pain in children: a randomized controlled trial. [2022]
The effects of hypnosis/guided imagery on the postoperative course of children. [2022]
Active Despite Pain: Patient Experiences With Guided Imagery With Relaxation Compared to Planned Rest. [2019]
Long-Term Follow-up of Individual Therapist Delivered and Standardized Hypnotherapy Recordings in Pediatric Irritable Bowel Syndrome or Functional Abdominal Pain. [2023]
A pilot study of the use of guided imagery for the treatment of recurrent abdominal pain in children. [2022]
Using guided imagery to reduce pain and anxiety. [2019]
The Effects of Brief Guided Imagery on Patients Suffering From Chronic Back Pain: An A-B Design Study. [2023]
Strategies for implementing a guided imagery program to enhance patient experience. [2019]
Children's and Caregivers' Review of a Guided Imagery Therapy Mobile App Designed to Treat Children With Functional Abdominal Pain Disorders: Leveraging a Mixed Methods Approach With User-Centered Design. [2023]
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