Guided Imagery Therapy for Abdominal Pain

Not yet recruiting at 1 trial location

Overseen By Hollier, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Abdominal surgeries, Cystic fibrosis, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of guided imagery therapy for children with chronic abdominal pain. Delivered through a mobile app, children listen to short sessions several times a week. The goal is to determine if these sessions can reduce pain when combined with their usual care. Children with persistent abdominal pain who are patients at Texas Children's Pediatrics might be suitable candidates.

As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative therapy while contributing to valuable research.

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 the guided imagery therapy is in addition to your usual care, so you may be able to continue your current treatments.

What prior data suggests that guided imagery therapy is safe for children with abdominal pain?

Research has shown that guided imagery therapy is generally safe and well-tolerated. A small study found that guided imagery helps reduce symptoms in children with functional abdominal pain, and the children did not experience major side effects.

Another study examined guided imagery therapy for people with COVID-19 and found it reduced anxiety and muscle pain without causing serious issues. This supports the idea that guided imagery is usually safe for many people.

Overall, guided imagery therapy, especially when used through a mobile app, is considered safe for children with functional abdominal pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Guided Imagery Therapy is unique because it offers a non-drug approach to managing abdominal pain, setting it apart from standard treatments like pain medications and dietary changes. This therapy involves using mental visualization techniques to create calming and healing images in the mind, which can help reduce stress and pain perception. Researchers are excited about this treatment because it provides an accessible, side-effect-free alternative that empowers patients to manage their symptoms through a mobile application, offering convenience and ease of use.

What evidence suggests that guided imagery therapy is effective for abdominal pain?

Research has shown that guided imagery therapy can help reduce stomach pain in children. One study found that listening to guided imagery recordings was more effective than regular medical care in reducing pain, disability, and the need for doctor visits. Another study suggested that guided imagery is a promising way to treat stomach pain disorders in children. This therapy helps children manage pain by using mental pictures and relaxation techniques. Overall, guided imagery therapy has demonstrated positive results and is considered an effective option for managing this type of stomach pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with chronic abdominal pain due to conditions like IBS or other gastrointestinal diseases. They must be able to use a mobile app and commit to an 8-week treatment plan, including listening sessions and diary entries. Children with hepatobiliary disorders or persistent surgical pain may also qualify.

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.

I have been diagnosed with a functional abdominal pain disorder.

Exclusion Criteria

Autism

Significant development delay

Psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Treatment

Participants use the guided imagery therapy mobile application for 8 weeks, listening to sessions 5 out of 7 days per week

8 weeks

Remote participation via mobile app

Follow-up

Participants complete abdominal pain and stooling diary, and other surveys 3 months post-treatment

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Guided Imagery Therapy

Trial Overview The study tests a guided imagery therapy (GIT) mobile app designed to help manage abdominal pain in children. Participants will listen to GIT sessions regularly over two months while maintaining their usual care, followed by evaluations immediately after and three months post-treatment.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1660537/

Evaluation of guided imagery as treatment for recurrent ... Guided imagery is one type of self-regulation technique that has been beneficial in treating other pain syndromes and now found, in this study, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06653647

Efficacy of Guided Imagery Therapy Mobile Application for ... The Delayed Treatment Group will be observed for the first 8 weeks after randomization, and then outcome data will be reassessed through abdominal pain and ...

3. publications.aap.org publications.aap.org/pediatrics/article/124/5/e890/72171/Audio-Recorded-Guided-Imagery-Treatment-Reduces

Audio-Recorded Guided Imagery Treatment Reduces ... Audio-recorded guided imagery treatment was superior to standard medical care in reducing abdominal pain, disability, and medical visits and ...

4. formative.jmir.org formative.jmir.org/2023/1/e41321

Children's and Caregivers' Review of a Guided Imagery ... Guided by user-centered design, this study captured the critiques of our GIT app from children with FAPDs and their caregivers.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561672218000056

Maternal and Child Acceptability of a Proposed Guided ... Of the various functional abdominal pain disorder treatment modalities, psychological therapies such as guided imagery therapy appear most effective.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7982304/

Effect of guided imagery on anxiety, muscle pain, and vital ... This study aimed to determine the effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19.

7. pure.psu.edu pure.psu.edu/en/publications/a-pilot-study-of-the-use-of-guided-imagery-for-the-treatment-of-r

A pilot study of the use of guided imagery for the treatment ... No baseline psychological characteristics impacted the response to therapy. The use of relaxation along with guided imagery is an effective and safe treatment ...

8. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/guided-imagery-APP.pdf

Guided Imagery, Biofeedback, and Hypnosis 10 pain/ or pain management/ or abdominal pain/ or abdomen, acute/ or acute pain/ or arthralgia/ or shoulder pain/ or back pain/ or failed back surgery ...