Trial Summary
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 Group
After 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.
Is Guided Imagery Therapy Mobile Application a promising treatment for abdominal pain?Yes, Guided Imagery Therapy Mobile Application is a promising treatment for abdominal pain. It uses imagination to help reduce pain and anxiety, and studies show it can be effective for children and adults. The mobile app makes it easier for people to access this helpful therapy.35689
What safety data exists for guided imagery therapy for abdominal pain?The research indicates that guided imagery therapy, also known as guided imagery with relaxation, is a well-studied complementary therapy used to reduce pain, stress, and anxiety. It has been evaluated in various contexts, including for children with recurrent abdominal pain and patients with chronic pain. The studies suggest that guided imagery is a non-pharmacological method that can improve patient experiences and healthcare outcomes, indicating a favorable safety profile.23569
Do I have to stop taking my current medications for the trial?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 idea that Guided Imagery Therapy for Abdominal Pain is an effective treatment?The available research shows that Guided Imagery Therapy can be effective for treating abdominal pain, especially in children. One study found that children with recurrent abdominal pain experienced a 67% decrease in pain after using guided imagery. Another study demonstrated that children who used guided imagery had significantly lower pain ratings and shorter hospital stays after surgery compared to those who did not use the therapy. These findings suggest that guided imagery can help reduce pain and improve recovery in children.14567
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
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.
I have been diagnosed with a functional abdominal pain disorder.
Exclusion Criteria
I have a condition like cystic fibrosis that causes abdominal pain.
I have had surgery in my abdomen before.
I have seen blood in my stool.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Baylor College of Medicine / Texas Children's HospitalHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
The effects of hypnosis/guided imagery on the postoperative course of children. [2022]Hypnosis, guided imagery, and relaxation have been shown to improve the postoperative course of adult surgical patients. Children have successfully used hypnosis/guided imagery to significantly reduce the pain associated with invasive procedures and to improve selected medical conditions. The purpose of this study was to examine the effect of hypnosis/guided imagery on the postoperative course of pediatric surgical patients. Fifty-two children (matched for sex, age, and diagnosis) were randomly assigned to an experimental or control group. The experimental group was taught guided imagery by the investigator. Practice of the imagery technique included suggestions for a favorable postoperative course. Significantly lower postoperative pain ratings and shorter hospital stays occurred for children in the experimental group. State anxiety was decreased for the guided imagery group and increased postoperatively for the control group. This study demonstrates the positive effects of hypnosis/guided imagery for the pediatric surgical patient.
Strategies for implementing a guided imagery program to enhance patient experience. [2019]The patient in acute care settings can have severe emotional and physical stresses that are also experienced by family and significant others. The experience in a hospital has often been described as overwhelming; it can evoke feelings of fear, anger, helplessness, and isolation. Guided imagery, one of the most well-studied complementary therapies, is used increasingly to improve patients' experiences and healthcare outcomes. More and more, patients are relying on the use of guided imagery to provide a significant source of strength, support, and courage as they prepare for a procedure or manage the stresses of a hospital stay. This article provides a brief review of the research base for guided imagery and broad indications for its use. It describes key elements of the therapy and outlines steps to implement a program of guided imagery that can be used in variety of settings.
Using guided imagery to reduce pain and anxiety. [2019]Guided imagery is a therapeutic technique that allows a person to use his or her own imagination to connect their body and mind to achieve desirable outcomes such as decreased pain perception and reduced anxiety. This article describes the use and application of guided imagery for clients in the home and the benefits to the agency. A step-by-step approach to teaching clients how to use guided imagery is included.
A pilot study of the use of guided imagery for the treatment of recurrent abdominal pain in children. [2022]Few effective therapies are available for children with recurrent abdominal pain (RAP). Relaxation and guided imagery have been shown to impact the autonomic nervous system, which is altered in patients with functional gastrointestinal disorders. Ten children with RAP were enrolled in the study after evaluation by a pediatric gastroenterologist. They were trained in relaxation and guided imagery during 4 weekly 50-minute sessions. Pain diaries were completed at 0, 1, and 2 months. Children and parents also completed psychological questionnaires at enrollment. Although refractory to conventional treatment by their physician and pediatric gastroenterologist, the children experienced a 67% decrease in pain during the therapy (chi-square for trend, p
Evaluation of guided imagery as treatment for recurrent abdominal pain in children: a randomized controlled trial. [2022]Because of the paucity of effective evidence-based therapies for children with recurrent abdominal pain, we evaluated the therapeutic effect of guided imagery, a well-studied self-regulation technique.
Active Despite Pain: Patient Experiences With Guided Imagery With Relaxation Compared to Planned Rest. [2019]Inadequate pain control remains a threat to the quality of life of patients with cancer. Guided imagery with relaxation (GIR) is a mind-body therapy that has shown promise in reducing chronic pain. This article discusses a qualitative, descriptive study for which the objective was to compare the experiences of patients with cancer with reported pain using GIR compared to planned rest. .
Long-Term Follow-up of Individual Therapist Delivered and Standardized Hypnotherapy Recordings in Pediatric Irritable Bowel Syndrome or Functional Abdominal Pain. [2023]We previously showed that standardized home-based gut-directed hypnosis exercises with compact disc (CD) is non-inferior to individual hypnotherapy (iHT) by a therapist in the treatment of children with irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)). Aim of this follow-up study was to investigate the long-term effects of standardized-hypnosis-recordings at home in comparison to iHT.
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]Functional abdominal pain disorders (FAPDs) are highly prevalent and associated with substantial morbidity. Guided imagery therapy (GIT) is efficacious; however, barriers often impede patient access. Therefore, we developed a GIT mobile app as a novel delivery platform.
The Effects of Brief Guided Imagery on Patients Suffering From Chronic Back Pain: An A-B Design Study. [2023]Guided imagery (GI) is a non-pharmacological method used to reduce pain, stress, and anxiety.