Guided Imagery Therapy for Abdominal Pain

Overseen By Laurel Cavallo

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Previous surgeries, Cystic fibrosis, Autism, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app that uses guided imagery therapy to help children with chronic abdominal pain. The goal is to determine if listening to guided imagery sessions can reduce pain when added to their usual care. Children who have experienced functional abdominal pain for at least two weeks and are patients at Texas Children's Pediatrics might be suitable candidates. Participants will either start using the app immediately or wait eight weeks before beginning. Both groups will listen to short sessions five days a week for eight weeks and track their symptoms.

As an unphased trial, this study offers participants a unique opportunity to explore innovative pain management techniques and contribute to advancing pediatric care.

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 prior data suggests that this guided imagery therapy mobile application is safe for children with abdominal pain?

Studies have shown that guided imagery therapy can help people manage pain by promoting relaxation and a sense of control. This is important because it can divert attention from the pain and its symptoms. Research also suggests that guided imagery can reduce abdominal pain in children.

A small study found that listening to guided imagery recordings reduced the frequency and severity of abdominal pain in children. Another study found that a guided imagery app was easy and helpful for both children and their parents to use.

While these studies are encouraging, guided imagery is generally safe with few reported side effects. However, as with any treatment, results can vary from person to person. Participants should keep this in mind and consult their healthcare provider if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Guided Imagery Therapy for abdominal pain because it offers a non-invasive, drug-free alternative to traditional pain management methods like medication and physical therapy. This therapy uses a mobile application, making it easily accessible and convenient for users, allowing them to engage in guided imagery sessions anytime and anywhere. Unlike standard treatments that often focus on physical symptoms, guided imagery aims to manage pain by harnessing the power of the mind, promoting relaxation and potentially reducing the perception of pain. This innovative approach has the potential to improve quality of life without the side effects associated with medication.

What evidence suggests that guided imagery therapy might be an effective treatment for abdominal pain?

Research has shown that guided imagery therapy can help reduce stomach pain in children. One study found that children who used guided imagery and muscle relaxation experienced fewer days with pain compared to those who did not. Another study demonstrated that listening to guided imagery recordings, along with regular medical care, was more effective for treating stomach pain than medical care alone. Additionally, several studies have shown that guided imagery can help reduce various types of pain not related to muscles or bones. In this trial, participants in the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application, while those in the Delayed Treatment arm will initially continue their usual care before crossing over to the guided imagery intervention. These findings suggest that guided imagery therapy could be a useful treatment for managing ongoing stomach pain in children. ^{3 6 7 8 9}

Who Is on the Research Team?

John M Hollier, MD, MS, MPH

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Delayed Treatment Experimental Treatment 1 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 Treatment Active Control 1 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

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+

Published Research Related to This Trial

Guided imagery is an effective therapeutic technique that helps individuals connect their mind and body, leading to reduced pain perception and decreased anxiety.

The article provides a detailed step-by-step approach for teaching clients how to use guided imagery, highlighting its practical application in home settings and the benefits it offers to both clients and healthcare agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using guided imagery to reduce pain and anxiety. Ackerman, CJ., Turkoski, B.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Despite Pain: Patient Experiences With Guided Imagery With Relaxation Compared to Planned Rest. Adeola, MT., Baird, CL., Sands, L., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of hypnosis/guided imagery on the postoperative course of children. Lambert, SA.[2022]

In a study involving 10 children with recurrent abdominal pain (RAP), relaxation and guided imagery techniques led to a significant 67% reduction in pain after 4 weekly sessions, demonstrating their efficacy as a treatment option.

The therapy was found to be safe and effective, with no baseline psychological factors affecting the children's response, suggesting that these techniques can be beneficial regardless of psychological background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the use of guided imagery for the treatment of recurrent abdominal pain in children. Ball, TM., Shapiro, DE., Monheim, CJ., et al.[2022]

Guided imagery is a well-researched complementary therapy that helps patients cope with the emotional and physical stresses of acute care settings, providing them with strength and support during challenging times.

The article outlines the implementation of guided imagery programs, highlighting its broad applicability in various healthcare settings to improve patient experiences and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for implementing a guided imagery program to enhance patient experience. Tusek, DL., Cwynar, RE.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The GIT mobile app for children with functional abdominal pain disorders received favorable usability ratings from both children and caregivers, with average scores above 78, indicating it is generally user-friendly.

However, 75% of children and 69% of caregivers experienced difficulties in setting reminder notifications, highlighting a key area for improvement, along with suggestions for enhancing the app's aesthetics and incorporating gamification to encourage regular use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Hollier, JM., Strickland, TA., Fordis, CM., et al.[2023]

A study involving 35 women with chronic back pain showed that brief guided imagery (GI) significantly reduced pain levels, anxiety, and improved daily activities after an 8-10 week intervention, with notable changes in pain ratings and anxiety scores.

The intervention included five group sessions where participants practiced GI exercises, leading to a significant decrease in pain (NPRS) and anxiety (STAI), although there was no significant change in fear-avoidance beliefs (FABQ).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Brief Guided Imagery on Patients Suffering From Chronic Back Pain: An A-B Design Study. Kaplun, A., Trosman, S., Reitblat, T., et al.[2023]

A follow-up study involving 227 children with irritable bowel syndrome (IBS) showed that both home-based gut-directed hypnosis using CDs and individual hypnotherapy (iHT) maintained long-term effectiveness, with over 80% of participants reporting adequate relief from abdominal complaints after 6 years.

Improvements in anxiety, depression, and other health-related factors were observed in both treatment groups, indicating that standardized home-based hypnosis is a viable, cost-effective alternative to traditional therapy for managing IBS and functional abdominal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of Individual Therapist Delivered and Standardized Hypnotherapy Recordings in Pediatric Irritable Bowel Syndrome or Functional Abdominal Pain. Rexwinkel, R., Bovendeert, JFM., Rutten, JMTM., et al.[2023]

Citations

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

Evaluation of guided imagery as treatment for recurrent ... Children who learned guided imagery with progressive muscle relaxation had significantly greater decrease in the number of days with pain than ...

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 ... CONCLUSION: Guided imagery treatment plus medical care was superior to standard medical care only for the treatment of abdominal pain, and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392412000942

Review Article Guided Imagery for Non-Musculoskeletal Pain Their methodological quality was generally poor. Eleven trials found that guided imagery led to a significant reduction of non-musculoskeletal pain. Four ...

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

Guided Imagery, Biofeedback, and Hypnosis Pain, disability- related41. 10 (N=380). Diagnosis- related. Absolute treatment effectiveness compared to no treatment or education only: medium weighted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10807512/

Meta-analytic evidence on the efficacy of hypnosis for mental ... The NCCIH recognizes evidence for the efficacy of hypnosis in the treatment of IBS, chronic pain, PTSD, and hot flashes (National Center for ...

7. sciencedirect.com sciencedirect.com/topics/nursing-and-health-professions/guided-imagery

Guided Imagery - an overview Guided imagery can be useful for helping people with pain relax, achieve a sense of control, and distract themselves from pain and accompanying symptoms. This ...

8. researchgate.net researchgate.net/publication/26888266_Audio-Recorded_Guided_Imagery_Treatment_Reduces_Functional_Abdominal_Pain_in_Children_A_Pilot_Study

Audio-Recorded Guided Imagery Treatment Reduces ... Primary outcome measures include the following: (1) Symptom improvement (abdominal pain frequency/severity) and (2) improvement in health-related quality of ...

9. pediatrics.jmir.org pediatrics.jmir.org/2018/1/e6/

Maternal and Child Acceptability of a Proposed Guided ... Conclusions: A guided imagery therapy app designed to treat pediatric patients with functional abdominal pain disorders appears to be acceptable ...